Bilioenteric Anastomosis by Magnetic Compressive Technique (BAMCT)

• ClinicalTrials.gov Identifier: NCT03774589
• Recruitment Status: Unknown
• First Posted: December 13, 2018
• Last Update Posted: November 18, 2019
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Health Science Center of Xi'an Jiaotong University; Northwest Institute for Non-ferrous Metal Research
• Information provided by (Responsible Party): First Affiliated Hospital Xi'an Jiaotong University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer; Cholangiocarcinoma; Bile Duct Injury; Choledochal Cyst; Biliary Calculi	Procedure: Magnetic Compressive Anastomosis; Procedure: Manual Anastomosis	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Bilioenteric Anastomosis by Magnetic Compressive Technique: A Prospective, Randomized Controlled Trial
• Actual Study Start Date: February 1, 2019
• Estimated Primary Completion Date: January 31, 2021
• Estimated Study Completion Date: January 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Magnetic Compressive Anastomosis; A magnetic device will be used during bilioenteric anastomosis.	Procedure: Magnetic Compressive Anastomosis; The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.
Active Comparator: Traditional Manual Anastomosis; A handsewn technique will be used during bilioenteric anastomosis.	Procedure: Manual Anastomosis; A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.

Outcome Measures

Primary Outcome Measures :

1. Bilioenteric anastomotic leakage [ Time Frame: 1 month post operation ]
   To compare the incidence of biliary leakage after magnetic or hand-sewn anastomosis

Secondary Outcome Measures :

1. Length of bilioenteric anastomosis time [ Time Frame: during operation ]
   To compare the anastomotic time between magnetic and hand-sewn groups
2. Time from the date of operation to expel of the magnets. [ Time Frame: 1 to 4 weeks postoperation ]
   To confirm the safe discharge of the magnets
3. average length of postoperative hospital stay [ Time Frame: 3 months ]
   To compare the length of stay between magnetic and hand-sewn groups
4. Bilioenteric anastomotic stricture [ Time Frame: 1,3,6,12-month post operation ]
   To compare the long-term outcome between magnetic and hand-sewn groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients with age between 18 to 75
• Patients' gender was not limited
• Patients who were well-diagnosed and had the indication for 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.

Contacts and Locations

Contacts

Contact: Yi Lv, MD,PHD; 86-29-85323900; luyi169@126.com

Contact: Xu-Feng Zhang, MD, PhD; 86-29-85323626; xfzhang125@126.com

Locations

China, Shaanxi

The First Affiliated Hospital of Xi'an Jiaotong University; Recruiting

Xi'an, Shaanxi, China, 710061

Contact: Yi Lv, MD，PHD 0086-13991200581 luyi169@126.com

Contact: Rongfeng Wang, MD 0086-15877553630 15877553630@163.com

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Health Science Center of Xi'an Jiaotong University

Northwest Institute for Non-ferrous Metal Research

Investigators

• Principal Investigator: Yi Lv, MD,PHD; China, Shaanxi First Affiliated Hospital of Xian JiaotongUniversity

More Information

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT03774589
• Other Study ID Numbers: XJTU1AF-CRF-2015-001-1
• First Posted: December 13, 2018
• Last Update Posted: November 18, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:

bilioenteric anastomosis; magnetic compressive technique; morbidity

Additional relevant MeSH terms:

Cholangiocarcinoma; Choledochal Cyst; Gallstones; Calculi; Neoplasms; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pathological Conditions, Anatomical; Cysts; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Abnormalities; Congenital Abnormalities; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases