Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- South Valley University
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- clinically relevant post operative pancreatic fistula
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
- •American Society of Anesthesiologists (ASA) scores I & II.
- •Patients aged > 20 years.
- •Agreement to complete the study.
Exclusion Criteria
- •Patients with benign disease, trauma, and receive neoadjuvant therapy.
- •double primary cancers.
Outcomes
Primary Outcomes
clinically relevant post operative pancreatic fistula
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohammed Ahmed Omar, MD
Associate professor of surgery
South Valley University