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

NCT07333755 | Completed Phase 4

• 1 other identifier: PT (672)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periampullary Carcinoma Resectable

Keywords

pancreaticoduodenectomy; omental flaps; Laparoscopic whipple operation

Outcome Measures

Primary Outcomes (1)

• The rate of pancreatic fistula after pancreaticoduodenectomy

  4 weeks postoperative

Study Arms (2)

A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue

ACTIVE COMPARATOR

Procedure: Pancreaticojejunostomy without omental patch

A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue

ACTIVE COMPARATOR

Procedure: Pancreaticojejunostomy with omental patch and glue

Interventions

Pancreaticojejunostomy with omental patch and glue PROCEDURE

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.

A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue

Pancreaticojejunostomy without omental patch PROCEDURE

A laparoscopic pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreatojejunostomy was created and not fixed with an omental patch or glue.

A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Resectable tumors of the periampullary region

You may not qualify if:

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

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, Egypt

Location

Related Publications (1)

• Maeda A, Ebata T, Kanemoto H, Matsunaga K, Bando E, Yamaguchi S, Uesaka K. Omental flap in pancreaticoduodenectomy for protection of splanchnic vessels. World J Surg. 2005 Sep;29(9):1122-6. doi: 10.1007/s00268-005-7900-3.

  PMID: 16132400 RESULT

MeSH Terms

Interventions

Pancreaticojejunostomy; Adhesives

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of general surgery

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: November 5, 2023
• Primary Completion: November 5, 2025
• Study Completion: November 5, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)