Antecolic Versus Retrocolic Gastrojejunostomy During Whipple's Procedure

June 5, 2025 updated by: Chrysoula-Christina Kolla, University of Thessaly

Antecolic Versus Retrocolic Gastrojejunostomy Following Pancreaticoduodenectomy: a Prospective Randomised Study

Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy.

Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded.

Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

76

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 Contact

Study Locations

      • Larissa, Greece, 41500
        • Recruiting
        • University of Thessaly
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age over 18 years old
  • Elective pancreaticoduodenectomy
  • Signed consent form

Exclusion Criteria:

  • Age under 18 years old
  • Patients who are participants in other trials that may affect the results of this study
  • Patients who do not consent to participate in the study

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antecolic gastrojejunostomy
Gastrojejunostomy in front of the transverse colon
Active Comparator: Retrocolic gastrojejunostomy
Gastrojejunostomy through the transverse mesocolon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed Gastric Emptying
Time Frame: 3 years
The occurence of delayed gastric emptying will be compared between two groups of patients: those who undergo an antecolic gastrojejunostomy and those who undergo a retrocolic approach.
3 years

Collaborators and Investigators

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

Investigators

  • Study Chair: Dimitrios Symeonidis, University of Thessaly

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 (Actual)

March 30, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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