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Completed

NCT Number: NCT02658643

Analysis of Biliodigestive Anastomosis Techniques (BDA)

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.

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Key information

Conditions

Continuous or Interrupted Suture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Dresden, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous suture technique

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

Procedure

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

Primary outcomes

  1. Time to complete the biliodigestive anastomosis

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 20, 2016
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.