Buttressed Pancreatico-Gastrostomy for Soft Pancreas With Small Diameter Pancreatic Duct in Whipple Procedure

Completed

• Conditions: Pancreatic Fistula
• Interventions: Procedure: Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures

• Registration Number: NCT05682768
• Lead Sponsor: South Valley University

Brief Summary

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

Detailed Description

Post-operative pancreatic fistula after Pancreaticoduodenectomy procedure, is still a major complication that might be affected by pancreatic stump reconstruction technique. More than 60 techniques were published in literature. Soft pancreas and small pancreatic duct size were major risk factors for post-operative pancreatic fistula. Supporting Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures is a new and safe technique for decreasing the risk of post-operative pancreatic fistula in high-risk patients.

The authors used this technique in pancreato-gastrostomy. Data were collected, tabulated and analyzed to evaluate the new technique and its impact on the incidence of post-operative pancreatic fistula.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2022-11-30
• Status Verified: 2022-12
• Study Completion: 2022-12-25
• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Patient diagnosed with resectable cancer head pancreas.
• Soft Pancreas.
• Small pancreatic duct diameter.

Exclusion Criteria

• Unresectable cancer pancreas.
• Non soft pancreas.
• Dilated pancreatic duct.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Duct to Mucosa Pancreatico-Gastrostomy with trans-pancreatic transverse mattress U- Shaped sutures	Patients with cancer pancreas with soft pancreas and non-dilated pancreatic duct

Primary Outcome Measures

Name	Time	Method
Post operative Pancreatic Fistula	up to 5 days (from time of surgery to time of detection of post-operative pancreatic fistula)	Detection of chemical or clinical pancreatic fluid discharge after post-operative day 3.

Trial Locations

Locations (1)

Qena Faculty of Medicine, South Valley University Hospitals; 🇪🇬 Qinā, Egypt