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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02801500
Study type Interventional
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Yi Lv, MD,PHD
Phone 0086-13991200581
Email luyi169@126.com
Status Recruiting
Phase N/A
Start date July 1, 2017
Completion date June 2019

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