NCT07333755CompletedPhase 4
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 Institute1 site in 1 country30 target enrollmentStarted: November 5, 2023Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The rate of pancreatic fistula after pancreaticoduodenectomy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Resectable tumors of the periampullary region
Exclusion Criteria
- •Pancreatic or duodenal tumors
- •Irresectability criteria (such as metastases, ascites, or arterial vascular invasion)
Arms & Interventions
A double-layered, end-to-side pancreaticojejunostomy without omental patch or glue
Active Comparator
Intervention: Pancreaticojejunostomy without omental patch (Procedure)
A double-layered, end-to-side pancreaticojejunostomy with omental patch and Glue
Active Comparator
Intervention: Pancreaticojejunostomy with omental patch and glue (Procedure)
Outcomes
Primary Outcomes
The rate of pancreatic fistula after pancreaticoduodenectomy
Time Frame: 4 weeks postoperative
Secondary Outcomes
No secondary outcomes reported
Investigators
Mahmoud Rady
Lecturer of general surgery
Theodor Bilharz Research Institute
Study Sites (1)
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