Details of a Researcher - Obara, Hideaki

Papers - Obara, Hideaki

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Phase I study of neoadjuvant S-1 plus cisplatin with concurrent radiation for biliary tract cancer (Tokyo Study Group for Biliary Cancer: TOSBIC02)

Abe Y., Itano O., Takemura Y., Minagawa T., Ojima H., Shinoda M., Kitago M., Obara H., Shigematsu N., Kitagawa Y.

Annals of Gastroenterological Surgery 7 ( 5 ) 808 - 818 2023.09

ISSN 2475-0328

Aim: Neoadjuvant chemoradiotherapy may improve survival in patients with advanced cholangiocarcinoma. This Phase I study aimed to determine the recommended dose of neoadjuvant chemoradiotherapy and decide whether to move to a Phase II study. Methods: Patients diagnosed with resectable stage II–IVa cholangiocarcinoma were administered cisplatin (40 [level 0], 50 [level 1 as starting dose], or 60 [level 2] mg/m2), 80 mg/m2 of S-1, and 50.4 Gy of external beam radiation. The recommended dose was defined as a dose one-step lower than the maximum-tolerated dose, which was defined when dose-limiting toxicity was observed in three or more of the six patients. Results: Twelve patients were eligible from November 2012 to May 2016. Ten patients had perihilar cholangiocarcinoma and two patients had distal cholangiocarcinoma. Dose-limiting toxicity was observed in one of the first six patients at level 1 and two of the next six patients at level 2; thus, the maximum-tolerated dose was not determined even at level 2 and the recommended dose was determined as level 2. Four patients had partial response, four patients had stable disease, and two patients had progression of disease because of liver metastases. Finally, nine patients underwent radical surgery and seven cases achieved R0 resection. However, five cases suffered biliary leakage and one suffered intrahospital death due to rupture of the hepatic artery. Conclusion: We determined the recommended dose of neoadjuvant chemoradiotherapy for resectable cholangiocarcinoma. However, we terminated the trial due to a high incidence of morbidity and unexpected mortality.

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Surgical Treatment for Popliteal Artery Entrapment Syndrome in Japan: a Retrospective, Multicentre Study Using a National Clinical Registry

Fujimura N., Obara H., Takahashi A., Miyata H., Hosaka A., Obitsu Y., Zempo N., Miyata T., Azuma N., Komori K.

European Journal of Vascular and Endovascular Surgery 66 ( 3 ) 381 - 388 2023.09

ISSN 10785884

Objective: Surgical treatment is an established method for popliteal artery entrapment syndrome (PAES), which, however, mainly derives from single centre experiences where PAES cases are centralised and treated periodically. This study evaluated clinical outcomes of surgical treatment for PAES in a clinical setting where PAES cases were not centralised. Methods: Multicentre, retrospective cohort study using a national clinical registry. From a Japanese nationwide clinical registry, data for patients who underwent surgical treatment for PAES between 2013 and 2018, including 58 limbs from 41 institutes, were retrieved and evaluated. Patency was analysed using Kaplan–Meier curves. Results: The mean patient age was 36 ± 19 years, 78% were male, and the incidence of PAES was 0.24 limbs/centre/year, reflecting a clinical setting where PAES cases are not centralised. The most frequent arterial symptom was intermittent claudication (90%). Computed tomography was performed in 57 limbs (98%) for the diagnosis, however active manoeuvres such as dorsiflexion and plantarflexion during the examination was performed in only 13 limbs (22%), and occlusion of the popliteal artery was present in 38 limbs (66%) at diagnosis. Regarding surgical treatment, myotomy alone was performed in only seven limbs (12%), and other limbs were revascularised. Mean follow up was 26 ± 20 months, and surgical treatment was effective as it relieved symptoms in > 96% of limbs, with five year primary and secondary patency of the surgical treatment for PAES of 72% and 93%, respectively. Conclusion: Results of surgical treatment were acceptable even in a clinical setting where PAES cases were not centralised. However, a low incidence of active manoeuvres performed during the examination and a high incidence of occlusion at diagnosis suggests there may be delayed or underdiagnosis of PAES in Japan, and increased awareness for PAES is warranted.

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Effect of aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on incidence of surgical site infections in gastrointestinal surgery: multicentre randomised controlled clinical trial (OEDO trial) protocol

Takeuchi M., Obara H., Furube T., Kawakubo H., Kitago M., Okabayashi K., Aoyama J., Amemiya R., Fujisaki H., Sano J., Goto R., Sato Y., Kitagawa Y.

BMJ Open 13 ( 8 ) e074169 2023.08

ISSN 2044-6055

Introduction Surgical site infections (SSIs) are among the most common nosocomial infections in surgery patients. Two types of preparations, povidone-iodine and chlorhexidine-alcohol, are commonly used in preoperative antiseptic procedures worldwide. However, there are inconsistencies among international guideline recommendations concerning skin antiseptics. This trial aimed to evaluate the superiority of olanexidine, which reduced SSI rates more than povidone-iodine in our previous randomised trial, over chlorhexidine-alcohol in clean-contaminated surgery. Methods and analysis This multicentre randomised controlled clinical trial will compare two antiseptics (1.5% olanexidine and 1.0% chlorhexidine-alcohol) to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. On providing consent, patients aged <18 years will be included. The primary outcome will be the postoperative 30-day overall SSI rate, while the secondary outcomes will be the postoperative 30-day superficial incisional SSI rate, deep incisional SSI rate, organ/space SSI rate, positive bacterial wound culture rate, cultured bacterial strains, rates of intervention-related toxicity and allergic events (eg, erythema, pruritus, dermatitis and other symptoms of allergy around the region disinfected by the antiseptic during surgery), rate of reoperations due to SSI, medical economic effect indicators (based on health insurance claims) and hospital duration. The Mantel-Haenszel method will be used to estimate the adjusted risk ratio and its 95% CI for the primary analysis, which will compare the treatment effects. Ethics and dissemination The protocol was approved by the Institutional Review Board of Keio University School of Medicine and subsequently by the board of each participating site. Participant recruitment began in January 2023. The final results will be published in medical journals after international peer review. Trial registration number UMIN000049712.

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Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort

Sekimoto Y., Fujimura N., Matsubara K., Uchida N., Asami A., Harada H., Shintani T., Watada S., Ono S., Fujii T., Shimogawara T., Hayashi K., Hayashi M., Obara H., Kitagawa Y.

Journal of Endovascular Therapy 30 ( 4 ) 571 - 579 2023.08

ISSN 15266028

Purpose: To compare the long-term outcomes of the most widely used third-generation stent grafts, the Endurant and Excluder stent grafts, in Japanese patients using a multicenter registry. Materials and Methods: A retrospective analysis of endovascular aneurysm repairs for abdominal aortic and iliac artery aneurysms using either the Endurant or the Excluder stent grafts from January 2012 to July 2019 at 10 Japanese hospitals was performed. Results: A total of 332 and 378 repairs using the Endurant and Excluder stent grafts, respectively, were analyzed. Although the patients’ characteristics were generally similar in the two groups, the Endurant group exhibited significantly shorter (Endurant: 31.5±18.6 mm, Excluder: 37.4±21.0 mm; p<0.001), larger (Endurant: 22.4±4.2 mm, Excluder: 21.7±3.8 mm; p=0.029), and more reversed tapered (Endurant: 12.1%, Excluder: 5.8%; p=0.003) proximal necks. The incidence of instructions for use (IFU) violations was similar between the two groups (Endurant: 59.0%, Excluder: 54.5%; p=0.223). However, the Endurant group had significantly more proximal neck-related IFU violations (54.1% and 46.3%, respectively; p=0.039), more access-related IFU violations (8.1% and 4.0%, respectively; p=0.019), and fewer bilateral hypogastric artery embolizations (5.1% and 9.3%, respectively; p=0.035) compared with the Excluder group. The incidence of intraoperative (Endurant: 3.6%, Excluder: 3.7%; p=0.950) and perioperative complications (Endurant: 3.6%, Excluder: 3.4%, p=0.899) was equivalent in the two groups. However, there was a significantly higher incidence of postoperative type II endoleaks in the Excluder group (Endurant: 28%, Excluder: 46.0%, p<0.001). Aneurysm sac regression was more frequent in the Endurant group (Endurant: 40.7%, Excluder: 31.7%, p=0.013). The Endurant group also had significantly higher rates of sac increase (Endurant: 13.0%, Excluder: 7.7%, p=0.020). Kaplan-Meier curve and log-rank analyses revealed no statistical differences in late complications (p=0.868) and overall survival (p=0.926). Conclusions: There were no statistically significant differences between the Endurant and the Excluder stent grafts in terms of intraoperative, perioperative, and late complication rates; however, the anatomical characteristics of the patients were significantly different.

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Japanese national survey on declined liver allografts from brain-dead donors: High decline rate but promising outcomes in allografts with moderate steatosis

Takemura Y., Shinoda M., Hasegawa Y., Yamada Y., Obara H., Kitago M., Kasahara M., Umeshita K., Eguchi S., Kitagawa Y., Ohdan H., Egawa H.

Annals of Gastroenterological Surgery 7 ( 4 ) 654 - 665 2023.07

ISSN 2475-0328

Aim: Liver allografts from brain-dead donors, which were declined and were eventually not transplanted due to accompanying marginal factors, have never been surveyed in Japan. We surveyed the declined allografts and discussed the graft potential focusing on various marginal factors. Methods: We collected data on brain-dead donors between 1999 and 2019 from the Japan Organ Transplant Network. We divided their liver allografts into declined (nontransplanted) and transplanted ones, and then characterized declined ones focusing on their timepoints of decline and accompanying marginal factors. For each marginal factor, we calculated the decline rate from the number of declined and transplanted allografts, and assessed the 1-year graft survival rate from transplanted allografts. Results: A total of 571 liver allografts were divided into 84 (14.7%) declined and 487 (85.3%) transplanted ones. In the declined allografts, a majority was declined after laparotomy (n = 55, 65.5%), most of which had steatosis and/or fibrosis (n = 52). Out of the moderate steatotic (without F ≥ 2 fibrosis) allografts (n = 33), 21 were declined and 12 were transplanted, leading to a 63.6% decline rate. The latter 12 achieved a 92.9% 1-year graft survival rate after transplantation. Comparison of donor background showed no significant difference between the declined and transplanted allografts. Conclusion: Pathological abnormalities of steatosis/fibrosis seem to be the most common donor factor leading to graft decline in Japan. Allografts with moderate steatosis were highly declined; however, transplanted ones achieved promising outcomes. This national survey highlights the potential utility of liver allografts with moderate steatosis.

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Comparison of Clinical Outcomes in Patients Undergoing Common Femoral Thromboendarterectomy With or Without Patch Angioplasty

Kobayashi T., Takahara M., Fujimura N., Ichihashi S., Kudo T., Okadome J., Obara H., Nakama T., Suzuki K., Yamaoka T.

European Journal of Vascular and Endovascular Surgery 65 ( 6 ) 870 - 877 2023.06

ISSN 10785884

Objective: Surgical thromboendarterectomy (TEA) is the standard treatment for an occlusive lesion of the common femoral artery (CFA). However, there is limited knowledge on the need for patch angioplasty in CFA TEA. The objective of this study was to compare the peri-operative and two year results of CFA TEA with or without patch angioplasty. Methods: A multicentre retrospective observational study was performed at 34 Japanese centres. Comparisons were made between patients undergoing CFA TEA with or without patch angioplasty after propensity score matching (PSM). The primary endpoints were primary patency and freedom from target lesion revascularisation (TLR) of the TEA lesion. The secondary endpoints were hospital outcomes, limb salvage, and overall survival. Results: Between 2018 and 2020, 428 TEA procedures (237 with patch angioplasty and 191 with primary closure) were performed. PSM extracted 151 pairs with no significant intergroup differences in baseline characteristics. Peri-operative death and complications occurred in 0.7% vs. 1.3% (p = 1.0) and 6.0% vs. 6.6% (p = 1.0), respectively. The follow up rate was 96% over a median follow up of 14.9 months (interquartile range 8.3, 24.3). Loss of primary patency occurred in 18 patients. The two year primary patency of patch angioplasty cases was statistically significantly higher than that of primary closure cases (97.0% vs. 89.9%; p = .021). TLR was performed in 14 patients. The two year freedom from TLR in patch angioplasty cases was also statistically significantly higher than in primary closure cases (98.6% vs. 92.9%; p = .003). During follow up, seven limbs required major amputation and 40 patients died. There was no statistically significant difference in limb salvage and survival between the two groups after PSM. Conclusions: This is the first report to show that patch angioplasty may decrease re-stenosis and target lesion revascularisation of CFA TEA lesions.

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Five-Year Outcomes of the Bioresorbable Peripheral Remedy Stent in the Treatment of Iliac Artery Disease

Obara H., Matsubara K., Fujimura N., Harada H., Okada M., Okui J., Sato Y., Fukuda K., Kitagawa Y.

Journal of Vascular and Interventional Radiology 34 ( 6 ) 1024 - 1035.e2 2023.06

ISSN 10510443

Purpose: To evaluate the 5-year performance of a bioresorbable vascular scaffold, the Remedy stent, for the treatment of iliac artery atherosclerotic disease. Materials and Methods: This prospective, multicenter, single-arm clinical study evaluated 97 patients (97 lesions) with symptomatic TransAtlantic Inter-Society Consensus II A/B iliac artery lesions for 5 years after stent placement. The primary efficacy end point was 12-month primary patency compared with the prespecified standard derived from historical data with metallic stents, and the primary safety end point was the occurrence of major adverse clinical events within 5 years. All angiographic and computed tomography angiographic findings were evaluated by an independent core laboratory for quantitative vessel analysis. Results: The 12-month primary patency rate was 88.6% (95% CI, 80.1%–94.4%), which was lower than the prespecified standard. No significant difference was noted between the diameter stenosis at 9 and 12 months. There were no device- or procedure-related deaths, major amputation, or distal embolization during the follow-up period. The ankle-brachial index maintained significant improvement through the 5-year period compared with that at baseline. The Kaplan–Meier estimates of freedom from target lesion revascularization (TLR), major adverse cardiovascular events, and major adverse cardiovascular and limb events were 95.8%, 91.7%, and 87.5% at 12 months and 85.4%, 72.1%, and 62.5% at 5 years, respectively. Conclusions: The 5-year follow-up outcomes, including freedom from TLR, of the Remedy stent in iliac artery lesions were satisfactory, with a good safety profile. Nevertheless, the 12-month primary patency did not meet the expected standard compared with that of contemporary metallic stents.

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Long-term Results of a Heparin-bonded Expanded Polytetrafluoroethylene Grafts for Above-the-knee Femoropopliteal Bypasses: A Japanese Prospective Multicenter Registry

Fujimura, N; Obara, H; Matsubara, K; Toya, N; Isogai, N; Ogino, H; Fujii, T; Kudo, T; Kanaoka, Y; Harada, H; Uchiyama, H; Guntani, A; Shimogawara, T; Shibutani, S; Ohki, T

JOURNAL OF VASCULAR SURGERY 77 ( 6 ) E183 - E184 2023.06

ISSN 0741-5214

Clot waveform analysis for perioperative hemostatic monitoring in a hemophilia A patient on emicizumab undergoing liver transplantation

Awane M., Wakui M., Ozaki Y., Kondo Y., Oka S., Fujimori Y., Yatabe Y., Arai T., Yamada Y., Hori S., Obara H., Hasegawa Y., Matsushita H.

Clinica Chimica Acta 544 117339 2023.04

ISSN 00098981

How to optimize perioperative factor VIII (FVIII) replacement through hemostatic monitoring is critically important to manage hemophilia A patients. The bispecific antibody emicizumab binds activated FIX (FIXa) and FX to functionally mimic FVIIIa. While being used for hemostatic control in hemophilia A, this therapeutic antibody inconveniently interferes with coagulation tests using human FIXa and FX, such as activated partial thromboplastin time (APTT) and FVIII activity measurement based on one-stage clotting assays. Clot waveform analysis (CWA) extends the interpretation of measurement curves for coagulation time to provide global information. We performed APTT-CWA to monitor perioperative hemostasis in a hemophilia A patient on emicizumab undergoing liver transplantation. Plasma samples were treated with anti-idiotype monoclonal antibodies against emicizumab to enable accurate coagulation assays. Kinetics of maximum coagulation velocity and acceleration mimicked that of FVIII activity. These CWA parameters better correlated with FVIII activity than APTT. The plateaus of them were observed at FVIII activity of 100% or more, supporting the protocol for perioperative FVIII replacement. Thus, CWA may measure coagulation potential in hemophilia A patients undergoing liver transplantation, aiding in optimizing perioperative hemostasis.

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Early Clinical Outcomes of Initial Launch of the Zenith Alpha Abdominal Endovascular Graft in Japan

Fujimura N., Ichihashi S., Obara H., Asakura T., Komooka M., Onitsuka S., Kurimoto Y., Kato H., Ohki T.

Journal of Endovascular Therapy 30 ( 2 ) 241 - 249 2023.04

ISSN 15266028

Purpose: This study retrospectively evaluated the 12-month outcomes of the Zenith Alpha Abdominal Endovascular graft (Zenith Alpha AAA, Cook, Inc, Bloomington, Indiana), which was launched partially in Japan in March 2019, starting with 9 selected sites. Methods: A retrospective analysis was performed of all endovascular aneurysm repairs (EVAR) for abdominal aortic aneurysms using the Zenith Alpha AAA. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including an aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reinterventions were excluded from late complications. Results: During the study period, 79 EVARs using the Zenith Alpha AAA were performed. The mean age was 76.6±6.9 years old, 91.1% of patients were male, and the mean aneurysm diameter was 51.1±7.5 mm. Instructions for use violation was observed in 27 patients (34.2%), most frequently being a severely angulated proximal neck (>60°). There were 4 intraoperative complications, including 2 unintentional partial renal artery coverages caused by the premature anchoring of the exposed suprarenal stent barb to the aortic wall, which was a result of the design change of the top cap deletion. Since it was a partial coverage without flow impairment and since renal stenting was unsuccessful, it was left untreated and had no subsequent renal function impairment. During the mean follow-up of 444±123 days, 74 patients completed 12 months of follow-up. Freedom from late complications at 12 months was 90.8%, which included 2 limb occlusions (2.5%). Of 71 patients with a 12-month computed tomography scan, there was only 1 type 1a endoleak (1.3%), 1 sac enlargement of >5 mm (1.3%), and an aneurysm sac shrinkage of >5 mm was observed in 42.2% of patients. There was no type 3 endoleak during the follow-up. Conclusions: This study demonstrated that the new generation of low-profile Zenith Alpha AAA has satisfactory early clinical outcomes, comparable to those obtained with the conventional Zenith endovascular graft. Long-term follow-up is needed to determine whether these favorable outcomes persist.

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Specificity of Presepsin as a Biomarker of Bacterial Infection in Mouse Sepsis Models

Hosokawa K., Obara H., Fukuda K., Mastubara K., Kitagawa Y.

Journal of Surgical Research 283 572 - 580 2023.03

ISSN 00224804

Introduction: Since its discovery in 2002, presepsin (P-SEP) has been reported to be useful in the early diagnosis of sepsis and has been evaluated in many clinical studies. However, as antibodies that bind to mouse P-SEP were previously unavailable, serum P-SEP levels in mice are limited. This study used a P-SEP enzyme-linked immunosorbent assay kit to evaluate the changes in serum P-SEP levels in mouse sepsis models compared with changes in other inflammatory markers and determine whether P-SEP can function as a biomarker specific to bacterial infections. Methods: Sepsis was induced in mice via cecal ligation and puncture (CLP), induction with lipopolysaccharide (LPS), and cecal ligation (CL) model was created as a control for the CLP model, following which clinical biomarkers (P-SEP, C-reactive protein, and procalcitonin) were evaluated. Results: The 48-h survival rates in the CLP, CL, and LPS-induced sepsis models were 67%, 89%, and 57%, respectively. Serum C-reactive protein levels did not increase in the CLP and CL models within 24 h but significantly increased in the LPS-induced sepsis model. Serum procalcitonin levels increased in the CLP and CL models and especially increased in the LPS-induced sepsis model. In contrast, an increase in serum P-SEP level was found in the CLP model at 6 h compared with those at baseline, the CL, and LPS-induced sepsis models. Conclusions: Mouse P-SEP is elevated early in infection and more specific to bacterial infection compared with other biomarkers.

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Early Clinical Outcomes of the Active Seal Technology of the AFX Endovascular Aortic Aneurysm System With the VELA Cuff for Patients With a Conical Proximal Neck

Fujimura N., Obara H., Nagano T., Ogawa Y., Kobayashi T., Ohmine T., Ozeki Y., Sakaguchi S., Yamaoka T., Ueda H., Sumi M., Taniguchi S., Ichihashi S.

Journal of Endovascular Therapy 30 ( 1 ) 114 - 122 2023.02

ISSN 15266028

Purpose: To evaluate the efficacy of the Active Seal technology employed in the AFX endovascular aortic aneurysm system (AFX), during endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysms (AAAs) having a conical proximal neck. Materials and Methods: A retrospective analysis of the EVAR for AAA with a conical proximal neck using the AFX was performed at 17 Japanese hospitals between January 2016 and August 2020. The conical proximal neck was defined as a cone-shaped proximal neck, with more than 10% diameter increase within a 15 mm length at the proximal landing zone. All anatomical analyses were performed in the core laboratory, and cases with parallel walls within the proximal neck adequate for the landing zone were excluded from the study. Results: This study included 53 patients, but only 39 patients (mean age, 76.6 ± 6.7 years; 87.0% males; mean aneurysm diameter, 52.0 ± 8.0 mm) were analyzed after being characterized as having a pure conical neck by the core laboratory. The mean proximal neck diameters at the lower renal artery and proximal edge of the aneurysm were 20.0 ± 2.9 mm and 27.5 ± 4.9 mm, respectively. The mean proximal neck length was 21.5 ± 6.0 mm. Instructions for use violations other than the conical neck were observed in 15 patients (38.5%). The VELA cuff was used in all cases; however, additional proximal cuff was required in 9 more cases (23.1%). The Active Seal technology was able to significantly extend the proximal sealing zone from 21.5 ± 6.0 to 26.0 ± 12.2 mm (p =.047). Thirty-six patients completed the 12-month follow-up (one patient was lost to follow-up, and 2 patients died from causes unrelated to the aneurysm), and there were no type-1a and 3 endoleaks with only one reintervention (2.6%) related to type 1b endoleak in the 12-month period. Furthermore, there was no significant enlargement of the proximal neck diameter at 12 months (at 1 month: 20.6 ± 3.4 mm and at 12 months: 21.3 ± 3.8 mm; p =.420). Conclusion: The Active Seal technology of the AFX significantly extended the proximal seal zone and no type-1a endoleak and proximal neck dilation was observed in patients with conical proximal neck at 12 months.

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Standardized upfront Glissonean approach and liver hanging maneuver reduces bile leakage from the hepatic hilum in living donors

Hirukawa K., Masuda Y., Abe Y., Yagi H., Ibuki S., Itano O., Shinoda M., Kitago M., Hasegawa Y., Hori S., Tanaka M., Nakano Y., Matsubara K., Obara H., Yamada Y., Kuroda T., Hibi T., Kitagawa Y.

Liver Transplantation 29 ( 1 ) 48 - 57 2023.01

ISSN 15276465

Biliary complications after hepatectomy in living donors have yet to be eradicated. We hypothesized that a standardized upfront Glissonean approach and liver hanging maneuver (GH) would prevent mechanical and thermal injuries to the hilar plate of the remnant liver by determining the point of bile duct division and the final destination of hepatectomy preceding liver parenchymal transection (safety) and facilitate liver transection deep within the parenchyma and allow maximum length of hilar structures (rationality). GH was implemented in 2016 and its incidence of bile leakage was retrospectively compared against the conventional technique. GH comprises six steps: (1) development of the retrohepatic avascular plane between the right hepatic vein (RHV) and the middle hepatic vein (MHV) and isolation of the hepatic vein(s); (2) isolation of the right or left Glissonean pedicle with the corresponding Glissonean pedicles of the caudate lobe; (3) for right liver grafts and left liver grafts with the caudate lobe, passage of the tape for the liver hanging maneuver along the retrohepatic avascular plane and above the hilar plate, and for left liver grafts without the caudate lobe and for left lateral section grafts, passage of the tape from between the RHV and the MHV, along the Arantius ligament, and to the right of the umbilical portion; (4) liver transection; (5) isolation of hilar structures; and (6) graft procurement. Until 2020, 62 consecutive living donors underwent GH (success rate, 100%). The incidence of bile leakage from the hepatic hilum (0%) was significantly lower than that among 59 donors who underwent the conventional technique in 2011-2015 (9%; p = 0.01). In conclusion, GH is highly effective in reducing bile leakage from the hepatic hilum in living donors.

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Adverse effects of long-term drain placement and the importance of direct aspiration: a retrospective cohort study

Okui J., Obara H., Uno S., Sato Y., Shimane G., Takeuchi M., Kawakubo H., Kitago M., Okabayashi K., Kitagawa Y.

Journal of Hospital Infection 131 156 - 163 2023.01

ISSN 01956701

Background: Long-term placement of prophylactic drains may result in retrograde infections. Aim: To investigate the association between the timing of drain removal and clinical outcomes. Methods: This retrospective, single-centre cohort study evaluated 110 patients who underwent elective gastrointestinal or hepatopancreatobiliary surgery and developed subsequent organ/space surgical site infection (SSI) between 2016 and 2020. The difference between the culture-positive species of prophylactic drains and direct aspiration was evaluated; whether the prophylactic drains functioned effectively at the time of SSI diagnosis; and whether the empirical antibiotics administered before drainage were effective against all the detected bacteria. Finally, clinical outcomes were compared between early (i.e. cases wherein the prophylactic drain had already been removed or replaced at the time of SSI diagnosis) and late (removal after diagnosis) drain removal. Findings: The prophylactic drains functioned effectively in only 27 (25%) patients at the time of SSI diagnosis. Due to the results of direct aspiration cultures, 43% of patients required antibiotic escalation. The median time to drain removal or first replacement was seven postoperative days. The early removal group included 43 patients (39%). Compared with early removal, late removal resulted in a higher frequency of vancomycin use (7.0% vs 22.4%; P = 0.037). Conclusion: Prolonged prophylactic drain placement is associated with complicated infections requiring vancomycin; therefore, the drains should be removed as soon as possible. Additionally, obtaining the cultures of direct aspiration should be actively considered, as escalation of antimicrobial therapy is often performed based on culture results.

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Prediction of need for bowel resection in acute superior mesenteric artery occlusion: A retrospective study of 48 Japanese patients

Watada S., Obara H., Okui J., Hosokawa K., Matsubara K., Harada H., Fujimura N., Fujii T., Shimogawara T., Kitagawa Y.

Annals of Gastroenterological Surgery 7 ( 1 ) 175 - 181 2023.01

ISSN 2475-0328

Aim: This study aimed to predict cases of acute superior mesenteric artery (SMA) occlusion requiring bowel resection using occlusion site and time from symptom onset to diagnosis at five Japanese institutions. Advances in imaging, endovascular treatment, and perioperative management have improved the clinical outcomes of patients with acute SMA occlusion; however, in clinical practice it remains difficult to effectively determine patients requiring bowel resection. Methods: We retrospectively analyzed the data of 48 patients (mean age: 82.5 y; male: 37.5%) diagnosed with acute SMA occlusion between June 2009 and August 2018. Background data of patients who required and did not require bowel resection were compared. A multivariable predictive model was developed using the time from symptom onset to diagnosis and whether SMA occlusion was proximal, including the origin of the middle colic artery. Results: Fifteen patients (31.3%) died during the hospital stay. Atrial fibrillation (83.3%) was the most common comorbidity. The median time from symptom onset to diagnosis was 13.0 (interquartile range, 4.75–24.0) h. Laparotomy, bowel resection, and thrombus embolectomy were performed in 41 (85.4%), 26 (54.2%), and 21 (43.8%) patients, respectively. A logistic regression model achieved 78.6% sensitivity in predicting cases not requiring bowel resection. Proximal occlusion was significantly associated with the requirement for bowel resection (P =.039). Conclusion: The time from symptom onset to diagnosis and occlusion site contributed to high sensitivity in determining the need for bowel resection in patients with acute SMA occlusion. Further prospective studies are warranted to investigate the clinical impact of this model.

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Successful Case of Deceased Donor Liver Transplant for Polycystic Liver Disease

Sugimoto H., Oshima Y., Oba Y., Ikuma D., Sekine A., Mizuno H., Yamanouchi M., Hasegawa E., Suwabe T., Chu P.S., Hasegawa Y., Obara H., Sawa N., Ubara Y.

Transplantation Proceedings 54 ( 10 ) 2779 - 2783 2022.12

ISSN 00411345

A 58-year-old woman was admitted to hospital for deceased donor liver transplant. Her liver volume, measured by computed tomography, had reached 22,764 cm3 and she was bedridden with performance status 3 because of abdominal distention. The Model for End-Stage Liver Disease score was 24 with exception points. The final weight of the removed liver after cystic fluid puncture was 14 kg. The patient recovered well after transplant and was discharged on postoperative day 43 with a weight of 41 kg and performance status of 1.

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Survey on the current status of the indication and implementation protocols for bile replacement in patients with external biliary drainage with special reference to infection control

Shinkawa H., Kubo S., Mikamo H., Matsuda N., Omura K., Okamoto K., Ono S., Obara H., Kobayashi M., Sasaki J., Shimizu J., Sueyoshi S., Yoshida J., Watanabe M., Takesue Y.

Surgery Today 52 ( 10 ) 1446 - 1452 2022.10

ISSN 09411291

Purpose: This survey of bile replacement (BR) was conducted on patients with external biliary drainage to assess the current status of indication and implementation protocol of BR with special reference to infection control. Methods: A 12-item questionnaire regarding the performance of perioperative BR was sent to 124 institutions in Japan. Results: BR was performed in 29 institutions, and the indication protocol was introduced in 19. BR was performed preoperatively in 11 institutions, pre- and postoperatively in 12, and postoperatively in 6. The methods used for BR administration included oral intake (n = 10), nasogastric tube (n = 1), enteral nutrition tube (n = 3), oral intake and enteral nutrition tube (n = 6), oral intake or nasogastric tube (n = 2), nasogastric tube and enteral nutrition tube (n = 2), and oral intake or nasogastric tube and enteral nutrition tube (n = 5). In 10 of 29 institutions, isolation of multidrug-resistant organisms and a high bacterial load were considered contraindications for the use of BR. Seven institutions experienced environmental contamination. Conclusions: Given the different implementation of BR among institutions, the appropriate indication and protocols for BR should be established for infection control.

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Development of a risk score model for 1-year graft loss after adult deceased donor liver transplantation in Japan based on a 20-year nationwide cohort

Takemura Y., Shinoda M., Takemura R., Hasegawa Y., Yamada Y., Obara H., Kitago M., Sakamoto S., Kasahara M., Umeshita K., Eguchi S., Ohdan H., Egawa H., Kitagawa Y.

Annals of Gastroenterological Surgery 6 ( 5 ) 712 - 725 2022.09

ISSN 2475-0328

Aim: Using nationwide data collected over the past 20 years, we aimed to investigate deceased donor liver transplantation (DDLT) outcomes to develop a unique risk model that can be used to establish a standard for organ acceptance in Japan. Methods: Data were collected for 449 recipients aged ≥18 years who underwent DDLT between 1999 and 2019. Least absolute shrinkage and selection operator (LASSO) regression analysis was utilized to develop an original risk score model for 1-year graft loss (termed the Japan Risk Index [JRI]). We developed risk indices according to recipient, donor, and surgery components (termed JRI-R, D, and S, respectively). The JRI was validated via a 5-fold cross-validation. We also compared DDLT outcomes and risk indices among Era1 (−2011), Era2 (−2015), and Era3 (−2019). Results: The 1-year graft survival rate was 89.5% and improved significantly, reaching 84.7%, 87.6%, and 93.9% in Era1, Era2, and Era3, respectively. The JRI was calculated as JRI-R (re-transplantation, Model for End-Stage Liver Disease score, medical condition in intensive care unit) × JRI-D (age, catecholamine index, maximum sodium, maximum total bilirubin) × JRI-S (total ischemic time) × 0.84. The risk model achieved a mean C-statistic value of 0.81 in the validation analysis. The risk index was significantly lower in Era3 than in Era2. Conclusion: Changes in the risk index over time indicated that avoiding risks contributed to the improved outcomes in Era3. The JRI is unique to adult DDLT in Japan and may be useful as a reference for organ acceptance in the future.

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In-situ bypass is associated with superior infection-free survival compared with extra-anatomic bypass for the management of secondary aortic graft infections without enteric involvement

Janko M.R., Hubbard G., Back M., Shah S.K., Pomozi E., Szeberin Z., DeMartino R., Wang L.J., Crofts S., Belkin M., Davila V.J., Lemmon G.W., Wang S.K., Czerny M., Kreibich M., Humphries M.D., Shutze W., Joh J.H., Cho S., Behrendt C.A., Setacci C., Hacker R.I., Sobreira M.L., Yoshida W.B., D'Oria M., Lepidi S., Chiesa R., Kahlberg A., Go M.R., Rizzo A.N., Black J.H., Magee G.A., Elsayed R., Baril D.T., Beck A.W., McFarland G.E., Gavali H., Wanhainen A., Kashyap V.S., Stoecker J.B., Wang G.J., Zhou W., Fujimura N., Obara H., Wishy A.M., Bose S., Smeds M., Liang P., Schermerhorn M., Conrad M.F., Hsu J.H., Patel R., Lee J.T., Liapis C.D., Moulakakis K.G., Farber M.A., Motta F., Ricco J.B., Bath J., Coselli J.S., Aziz F., Coleman D.M., Davis F.M., Fatima J., Irshad A., Shalhub S., Kakkos S., Zhang Q., Lawrence P.F., Woo K., Chung J.

Journal of Vascular Surgery 76 ( 2 ) 546 - 555.e3 2022.08

ISSN 07415214

Objective: The optimal revascularization modality following complete resection of aortic graft infection (AGI) without enteric involvement remains unclear. The purpose of this investigation is to determine the revascularization approach associated with the lowest morbidity and mortality using real-world data in patients undergoing complete excision of AGI. Methods: A retrospective, multi-institutional study of AGI from 2002 to 2014 was performed using a standardized database. Baseline demographics, comorbidities, and perioperative variables were recorded. The primary outcome was infection-free survival. Descriptive statistics, Kaplan-Meier survival analysis, and univariate and multivariable analyses were performed. Results: A total of 241 patients at 34 institutions from seven countries presented with AGI during the study period (median age, 68 years; 75% male). The initial aortic procedures that resulted in AGI were 172 surgical grafts (71%), 66 endografts (27%), and three unknown (2%). Of the patients, 172 (71%) underwent complete excision of infected aortic graft material followed by in situ (in-line) bypass (ISB), including antibiotic-treated prosthetic graft (35%), autogenous femoral vein (neo-aortoiliac surgery) (24%), and cryopreserved allograft (41%). Sixty-nine patients (29%) underwent extra-anatomic bypass (EAB). Overall median Kaplan-Meier estimated survival was 5.8 years. Perioperative mortality was 16%. When stratified by ISB vs EAB, there was a significant difference in Kaplan-Meier estimated infection-free survival (2910 days; interquartile range, 391-3771 days vs 180 days; interquartile range, 27-3750 days; P < .001). There were otherwise no significant differences in presentation, comorbidities, or perioperative variables. Multivariable Cox regression showed lower infection-free survival among patients with EAB (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.6-3.6; P < .001), polymicrobial infection (HR, 2.2; 95% CI, 1.4-3.5; P = .001), methicillin-resistant Staphylococcus aureus infection (HR, 1.7; 95% CI, 1.1-2.7; P = .02), as well as the protective effect of omental/muscle flap coverage (HR, 0.59; 95% CI, 0.37-0.92; P = .02). Conclusions: After complete resection of AGI, perioperative mortality is 16% and median overall survival is 5.8 years. EAB is associated with nearly a two and one-half-fold higher reinfection/mortality compared with ISB. Omental and/or muscle flap coverage of the repair appear protective.

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Reappraisal of liver transplantation for erythropoietic protoporphyria: A deadly combination of disease recurrence and biliary complication

Endo Y., Hibi T., Shinoda M., Obara H., Kitago M., Yagi H., Abe Y., Hasegawa Y., Matsubara K., Hori S., Tanaka M., Makiuchi S., Nakano Y., Itano O., Kuroda T., Kitagawa Y.

Pediatric Transplantation 26 ( 4 ) e14261 2022.06

ISSN 13973142

Background: Erythropoietic protoporphyria (EPP) is a rare inherited disorder that causes the accumulation of protoporphyrin in the erythrocytes, skin, and liver. Severe protoporphyric hepatopathy results in liver failure, requiring both liver and bone marrow transplantation as a life-saving procedure and to correct the underlying enzymatic defect, respectively. Case presentation: We report a 20-year-old man who underwent split liver transplantation using a right trisegment and caudate lobe graft for EPP-induced liver failure, but succumbed to a deadly combination of early relapse of EPP and subsequent, intractable, late-onset bile leakage from the cut surface of segment 4. EPP recurrence most likely created a high-risk situation for bile leakage from the non-communicating bile ducts of segment 4; therefore, this case shed light on the potential relationship between EPP recurrence and biliary complications. Conclusion: Physicians should recognize the potentially rapid and life-threatening progression of protoporphyric hepatopathy that leads to liver failure. For young patients with EPP, LT and sequential BMT should thoroughly be considered by a multidisciplinary team as soon as hepatic reserve deterioration becomes evident. Split liver transplantation should preferably be avoided and appropriate post-transplant management is critical before protoporphyrin depositions to the bile duct and hepatocyte causes irreversible damage to the liver graft.

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