Analysis of Biliodigestive Anastomosis Techniques (BDA)

Technische Universität Dresden

Status: Completed

Conditions: Continuous or Interrupted Suture

Treatments: Procedure: Interrupted suture technique; Procedure: Continuous suture technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02658643

VTG-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Continuous suture technique

Experimental group

Description:

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

Treatment:

Procedure: Continuous suture technique

Interrupted suture technique

Active Comparator group

Description:

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

Treatment:

Procedure: Interrupted suture technique