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A magnetic device will be used during bilioenteric anastomosis.

A handsewn technique will be used during bilioenteric anastomosis.

The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.

Magnetic Compressive Anastomosis

A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.

Manual Anastomosis

Yi Lv, MD,PHD

Xu-Feng Zhang, MD, PhD

Yi Lv, MD，PHD

Rongfeng Wang, MD

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on bilioenteric anastomosis.

The bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study. This study is a prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive bilioenteric anastomosis versus traditional suture method on incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need bilioenteric anastomosis operation. The study is to enroll about 200 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.

Bilioenteric Anastomosis by Magnetic Compressive Technique

Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial

To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis

To compare the anastomotic time between magnetic and hand-sewn groups

To confirm the safe discharge of the magnets

To compare the length of stay between magnetic and hand-sewn groups

To compare the long-term outcome between magnetic and hand-sewn groups

Health Science Center of Xi'an Jiaotong University

Northwest Institute for Non-ferrous Metal Research

First Affiliated Hospital Xi'an Jiaotong University

Klatskin Tumor

The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.

Xiaopeng Yan, PHD

The purpose of this study is to determine whether the magnetic compressive anastomosis has a better outcomes than traditional manual anastomosis on superior bilioenteric anastomosis.

The superior bilioenteric anastomosis is one of the most common and difficult operations in Hepatobiliary Surgery. The traditional manual anastomosis has become one of the main prognosis factors because of the length of suture time, the difficulty of operation, the high incidence of anastomotic leakage and stricture. Magnetic compressive anastomosis can realize the fast anastomosis, reduce the difficulty, and reduce the incidence of anastomotic leakage and stricture. Currently, the majority of studies of magnetic compressive bilioenteric anastomosis are merely confined within clinical case report and single-center, small sample, retrospective study, thus they are lack of convictive evidence of evidence-based medicine for the security, reliability and convince.

This study is a multicenter, prospective, randomized controlled trial. To evaluate the security, reliability and convince of magnetic compressive superior bilioenteric anastomosis, this study compared the incidence of anastomotic leakage and stricture between magnetic compressive anastomosis and traditional manual anastomosis among patients who need superior bilioenteric anastomosis operation. The study design plan to enroll 70 patients and divide into Study Group (Group A: Magnetic compressive anastomosis) and Control Group (Group B: traditional manual anastomosis) as 1:1 ratio randomly by stratification factors. The incidence of anastomotic leakage and stricture, length of bilioenteric anastomosis time, value of serum bilirubin, length of discharge time of magnetic device and mean time of hospital stay will be evaluated. The patients will drop out of the study if adverse events happen, active request for dropping out, new-onset severe disease or death. The primary and secondary end point will be observed by regular follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bilioenteric Anastomosis by Magnetic Compressive Technique	NCT03774589	Pancreatic Canc... Cholangiocarcin... Bile Duct Injur... Choledochal Cys... Biliary Calculi	Magnetic Compre... Manual Anastomo...	18 Years - 75 Years	First Affiliated Hospital Xi'an Jiaotong University
Bilioenteric Anastomosis by Magnetic Compressive Technique	NCT03774589	Pancreatic Canc... Cholangiocarcin... Bile Duct Injur... Choledochal Cys... Biliary Calculi	Magnetic Compre... Manual Anastomo...	18 Years - 75 Years	First Affiliated Hospital Xi'an Jiaotong University
Superior Bilioenteric Anastomosis by Magnetic Compressive Technique	NCT02801500	Hilar Cholangio... Bile Duct Injur... Choledochal Cys... Biliary Calculi	Magnetic Compre... Manual Anastomo...	18 Years - 75 Years	First Affiliated Hospital Xi'an Jiaotong University

Spots Global Cancer Trial Database for biliary calculi