Analysis of Biliodigestive Anastomosis Techniques (BDA)

NCT ID: NCT02658643

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-20
• Study Completion Date: 2019-09-17

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.

Conditions

Continuous or Interrupted Suture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Continuous suture technique

Intervention Type: PROCEDURE

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

The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis

Group Type: ACTIVE_COMPARATOR

Interrupted suture technique

Intervention Type: PROCEDURE

The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Reißfelder, MD

Role: PRINCIPAL_INVESTIGATOR

christoph.reissfelder@uniklinikum-dresden.de

Locations

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

Dresden, , Germany

Countries

Germany

References

Seifert L, von Renesse J, Seifert AM, Sturm D, Meisterfeld R, Rahbari NN, Kahlert C, Distler M, Weitz J, Reissfelder C. Interrupted versus continuous suture technique for biliary-enteric anastomosis: randomized clinical trial. BJS Open. 2023 Jan 6;7(1):zrac163. doi: 10.1093/bjsopen/zrac163.

Reference Type: DERIVED

PMID: 36723996 (View on PubMed)

Other Identifiers

VTG-06

Identifier Type: -

Identifier Source: org_study_id