Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

Not Applicable

• Conditions: Hilar Cholangiocarcinoma; Bile Duct Injury; Choledochal Cyst; Biliary Calculi
• Interventions: Device: Magnetic Compressive Anastomosis; Procedure: Manual Anastomosis

• Registration Number: NCT02801500
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2016-05-29
• Study First Submitted QC: 2016-06-11
• Study First Posted: 2016-06-16
• Study Start: 2017-07-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-21
• Primary Completion: 2018-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Patients with age between 18 to 75
• Patients' gender was not limited
• Patients who were well-diagnosed and had the indication for superior bilioenteric anastomosis.
• Patients whose lifetimes will be longer than 12 months.
• Patients who are willing to join this clinical trial and informed consent form voluntarily.

Exclusion Criteria

• Woman during pregnancy or lactation or anyone with mental disorder
• The wall of hepatic duct or jejunum was too thick so that the attractive force of magnetic device cannot meet the requirements of compression.
• Any anatomical variation in bile ducts system or the inner diameter is too small so that the magnetic device cannot place in.
• Any foreign body has been implanted in body, such as heart pacemaker.
• Surgical contraindication, including:

Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long-term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.

• Any other disease in perioperation periods which needs MRI examination in the next 8 weeks post operation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Compressive Anastomosis	Magnetic Compressive Anastomosis	A magnetic device will be used during bilioenteric anastomosis.
Traditional Manual Anastomosis	Manual Anastomosis	A handsewn technique will be used during bilioenteric anastomosis.

Primary Outcome Measures

Name	Time	Method
Bilioenteric anastomotic leakage	1 month post operation

Secondary Outcome Measures

Name	Time	Method
Bilioenteric anastomotic stricture	Time Frame: 1,3,6,12-month post operation
Length of bilioenteric anastomosis time	during operation
Number of patients who have discharged the device on the date expected.	1 to 4 weeks postoperation
Number of patients who have been diagnosed as discharge disorder of magnetic device	less than 1 week or more than 4 weeks
average length of postoperative hospital stay	3 months
Times of pathological examination of bile duct's remnant of Klatskin' tumor	during operation

Trial Locations

Locations (2)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

First Affiliated Hospital of Xian JiaotongUniversity; 🇨🇳 Xi'an, Shaanxi, China