A Multi-Facility, Randomized, Comparative Study Examining the Efficacy of Biliary Reconstruction Under a Surgical Microscope in Living Donor Liver Transplantation.

Akihiko Soyama,Mitsuhisa Takatsuki,Takeo Toshima,Hajime Imamura,Susumu Eguchi,Masaaki Hidaka,Takanobu Hara,Tomoharu Yoshizumi,Shinichiro Ono,Tomohiko Adachi,Hajime Matsushima,Takayuki Tanaka,Noboru Harada

doi:10.29337/ijsp.151

Akihiko Soyama, Mitsuhisa Takatsuki + Show 11 more

Open Access

https://doi.org/10.29337/ijsp.151

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Abstract

Introduction:Postoperative biliary complications in living donor liver transplantation are often difficult to treat, and if treatment is not successful, the patient’s QOL is significantly reduced. The frequency of postoperative biliary complications is reported to be higher than that of deceased donor transplantation. In 2013, Lin et al. reported that while biliary reconstruction has traditionally used a surgical surgical loupe (2.5x–4.5x), biliary reconstruction using a surgical microscope (5x–15x) can reduce the incidence of complications. The objective of this study is to clarify the efficacy of biliary reconstruction using surgical microscope in living donor liver transplantation by a multi-facility, randomized comparative study.Methods and analysis:It is an open-label randomized controlled study in which target patients who meet the registration requirements are randomly allocated to a surgical loupe group and a microscopy group after obtaining their consent (Ratio 1:1). The primary endpoint is an incidence of biliary complications (bile leakage and anastomotic biliary stricture) with Clavien-Dindo class III or higher within 52 weeks following surgery. The secondary endpoint is length of time required for biliary reconstruction using a surgical microscope.Ethics and dissemination:This study protocol was approved by the institutional review board of Nagasaki University Hospital (No. 20122102-2). The study is registered in UMIN-CTR as UMIN000042011. Written informed consent will be obtained from all participants. The results will be published in a peer-reviewed journal and will be presented at medical meetings.HighlightsPostoperative biliary complications in living donor liver transplantation are often difficult to treat.Lower incidence of biliary complication following biliary reconstruction using a surgical microscope has been reported.Facilities those use a surgical microscope for biliary reconstruction are limited.The first study to investigate the efficacy of surgical microscope for biliary construction in liver transplantation by randomized controlled trial.

Highlights

Postoperative biliary complications in living donor liver transplantation are often difficult to treat, and if treatment is not successful, the patient’s QOL is significantly reduced
The secondary endpoint is length of time required for biliary reconstruction using a surgical microscope
If this study proves the usefulness of biliary reconstruction using a microscope, the technique will become one standard technique, with expectations of low incidence of biliary complications following liver transplantation as well as improved patient QOL by performing this technique

Summary

Methods and analysis

It is an open-label randomized controlled study in which target patients who meet the registration requirements are randomly allocated to a surgical loupe group and a microscopy group after obtaining their consent (Ratio 1:1). The primary endpoint is an incidence of biliary complications (bile leakage and anastomotic biliary stricture) with Clavien-Dindo class III or higher within 52 weeks following surgery. The secondary endpoint is length of time required for biliary reconstruction using a surgical microscope. Ethics and dissemination: This study protocol was approved by the institutional review board of Nagasaki University Hospital (No 20122102-2). The results will be published in a peer-reviewed journal and will be presented at medical meetings. A Multi-Facility, Randomized, Comparative Study Examining the Efficacy of Biliary Reconstruction Under a Surgical Microscope in Living Donor Liver Transplantation.

BACKGROUND

OBJECTIVE

EXPECTED RESULTS

STUDY DESIGN

No gender restrictions

DISCUSSION