Analysis of Biliodigestive Anastomosis Techniques (BDA)

Not Applicable

Completed

• Conditions: Continuous or Interrupted Suture
• Interventions: Procedure: Continuous suture technique; Procedure: Interrupted suture technique

• Registration Number: NCT02658643
• Lead Sponsor: Technische Universität Dresden

Brief Summary

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.

Detailed Description

The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.

Study Timeline

• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-15
• Study Start: 2016-01-20
• Study First Posted: 2016-01-20
• Primary Completion: 2019-09-17
• Study Completion: 2019-09-17
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients over 18 years of age
• Scheduled for elective BDA procedure
• Primary BDA procedure
• Diameter of DHC > 7mm
• Written consent

Exclusion Criteria

• Previous BDA procedure
• Impaired mental state or language problems
• Lacking compliance
• Emergency procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous suture technique	Continuous suture technique	The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
Interrupted suture technique	Interrupted suture technique	The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis

Primary Outcome Measures

Name	Time	Method
Time to complete the biliodigestive anastomosis	30 minutes

Trial Locations

Locations (1)

Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany; 🇩🇪 Dresden, Germany