Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

Completed

• Conditions: Pancreatic Fistula
• Interventions: Procedure: pancreaticoduodenectomy procedure

• Registration Number: NCT05687825
• Lead Sponsor: South Valley University

Brief Summary

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Detailed Description

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Study First Submitted: 2023-01-08
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

1. Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
2. American Society of Anesthesiologists (ASA) scores I & II.
3. Patients aged > 20 years.
4. Agreement to complete the study.

Exclusion Criteria

1. Patients with benign disease, trauma, and receive neoadjuvant therapy.
2. double primary cancers.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinically relevant postoperative pancreatic fistula	pancreaticoduodenectomy procedure	patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy
No clinically relevant postoperative pancreatic fistula	pancreaticoduodenectomy procedure	patients who did not develop clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

Primary Outcome Measures

Name	Time	Method
clinically relevant post operative pancreatic fistula	10 days	A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day

Trial Locations

Locations (1)

Qena faculty of Medicine, South Valley University; 🇪🇬 Cairo, Egypt