New Technique of End-to-Side Two-Layered Duct-to-Mucosa Pancreaticojejunostomy With Omental Wrapping and Glue (Glubran 2) During Laparoscopic Whipple Operation

December 30, 2025 updated by: Mahmoud Rady, Theodor Bilharz Research Institute
Following pancreaticoduodenectomy, omental flaps around the pancreatic anastomosis and adhesive glue can lower the risk of pancreatic fistula, post-pancreatectomy bleeding, and delayed gastric emptying. The overall morbidity following pancreaticoduodenectomy can be decreased with this straightforward and efficient treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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

  • Egypt
      • Giza, Egypt
        • Theodor Bilharz Research Institute

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:

- Resectable tumors of the periampullary region

Exclusion Criteria:

  • Pancreatic or duodenal tumors
  • Irresectability criteria (such as metastases, ascites, or arterial vascular invasion)

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue
Procedure: Pancreaticojejunostomy without omental patch
A laparoscopic pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreatojejunostomy was created and not fixed with an omental patch or glue.
Active Comparator: A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue
Procedure: Pancreaticojejunostomy with omental patch and glue
A laparoscopic pancreaticoduodenectomy was performed on each patient. A pancreaticojejunostomy was fixed with glue to secure the anastomosis. The greater omentum was separated longitudinally over an avascular zone, and one or two omental branches of the gastroepiploic arteries were preserved using pedicle omental flaps. The omentum was rolled up and secured with glue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of pancreatic fistula after pancreaticoduodenectomy
Time Frame: 4 weeks postoperative
4 weeks postoperative

Collaborators and Investigators

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

Sponsor

Theodor Bilharz Research Institute

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.

General Publications

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)

November 5, 2023

Primary Completion (Actual)

November 5, 2025

Study Completion (Actual)

November 5, 2025

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT (672)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared upon request from the principle investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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