Clinical Trial: Superior Bilioenteric Anastomosis by Magnetic Compressive Technique

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Current Primary Outcome: Bilioenteric anastomotic leakage [ Time Frame: 1 month post operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of bilioenteric anastomosis time [ Time Frame: during operation ]
  • Number of patients who have discharged the device on the date expected. [ Time Frame: 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 ]
  • average length of postoperative hospital stay [ Time Frame: 3 months ]
  • Times of pathological examination of bile duct's remnant of Klatskin' tumor [ Time Frame: during operation ]
  • Bilioenteric anastomotic stricture [ Time Frame: Time Frame: 1,3,6,12-month post operation ]


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital Xi'an Jiaotong University

Dates:
Date Received: May 29, 2016
Date Started: June 2016
Date Completion: June 2019
Last Updated: June 11, 2016
Last Verified: May 2016