Billroth II Versus Roux-en-Y for the Gastrojejunostomy in the Pancreatoduodenectomy

August 26, 2016 updated by: Fundacion Miguel Servet

Billroth II Versus Roux-en-Y for the Gastrojejunostomy Reconstruction in the Pancreatoduodenectomy: a Randomized Controlled Study

The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Complejo Hospitalario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive series of patients undergoing pancreaticoduodenectomy (PD).
  • Given informed consent.

Exclusion Criteria:

  • Inability to perform pancreatogastrostomy.
  • Resection of other organs, except the superior mesenteric-portal vein.
  • Previous gastric surgery.
  • Preoperative gastric or duodenal obstruction.
  • Previous complex abdominal surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roux-en-Y
Roux-en-Y for the gastrojejunostomy reconstruction
Procedure: Roux-en-Y for the gastrojejunostomy reconstruction
Active Comparator: Billroth II
Billroth II for the gastrojejunostomy reconstruction
Procedure: Billroth II for the gastrojejunostomy reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of delayed gastric emptying (DGE)
Time Frame: 30 day after surgery
30 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Miguel Servet

Investigators

  • Principal Investigator: Francisco Javier Herrera, MD, Complejo Hospitalario de Navarra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 14, 2013

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • CIRUGIA-CHN
  • 2013-000693-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatoduodenectomy

Clinical Trials on Roux-en-Y for the gastrojejunostomy reconstruction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe