Analysis of Biliodigestive Anastomosis Techniques (BDA)

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Completed
• CT.gov ID: NCT02658643
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.9
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Continuous or Interrupted Suture	Procedure: Continuous suture technique; Procedure: Interrupted suture technique	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Study to Determine the Difference in Time and Complication Rate for Biliodigestive Anastomosis by Continuous Versus Interrupted Suture Technique
• Actual Study Start Date: Jan 20, 2016
• Actual Primary Completion Date: Sep 17, 2019
• Actual Study Completion Date: Sep 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Procedure: 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
Active Comparator: 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	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

Outcome Measures

Primary Outcome Measures

1. Time to complete the biliodigestive anastomosis [30 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany	Dresden		Germany

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

• Principal Investigator: Christoph Reißfelder, MD, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Technische Universität Dresden
• ClinicalTrials.gov Identifier: NCT02658643
• Other Study ID Numbers: VTG-06
• First Posted: Jan 20, 2016
• Last Update Posted: Oct 22, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Technische Universität Dresden: biliodigestive anastomosis techniques

Study Results

No Results Posted as of Oct 22, 2019