Analysis of Biliodigestive Anastomosis Techniques (BDA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique

Conditions
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Continuous or Interrupted Suture

Intervention / Treatment
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* Procedure: Continuous suture technique
* Procedure: Interrupted suture technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous suture technique<br>The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis | Procedure: Continuous suture technique<br>* The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis<br>|
| Active Comparator: Interrupted suture technique<br>The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis | Procedure: Interrupted suture technique<br>* The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete the biliodigestive anastomosis |  | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biliodigestive anastomosis techniques