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

Theodor Bilharz Research Institute

Status and phase: Completed; Phase 4

Conditions: Periampullary Carcinoma Resectable

Treatments: Procedure: Pancreaticojejunostomy with omental patch and glue; Procedure: Pancreaticojejunostomy without omental patch

Study type: Interventional

Funder types: Other

Identifiers

NCT07333755

PT (672)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

- Resectable tumors of the periampullary region

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

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

Active Comparator group

Treatment:

Procedure: Pancreaticojejunostomy without omental patch

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

Active Comparator group

Treatment:

Procedure: Pancreaticojejunostomy with omental patch and glue