Superior Bilioenteric Anastomosis by Magnetic Compressive Technique (CTREG)

September 19, 2017 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xian JiaotongUniversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic Compressive Anastomosis
A magnetic device will be used during bilioenteric anastomosis.
Device: Magnetic Compressive Anastomosis
The magnetic compressive anastomosis device 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bilioenteric anastomotic leakage
Time Frame: 1 month post operation
1 month post operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Shaanxi Provincial People's Hospital
Tang-Du Hospital
General Hospital of Ningxia Medical University
First Affiliated Hospital of Xinjiang Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

May 29, 2016

First Submitted That Met QC Criteria

June 11, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2015-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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