FindTrial
Sign In

Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

Operative Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Multicenter Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05687825
Enrollment
107
Registered
2023-01-18
Start date
2017-08-01
Completion date
2022-07-30
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Fistula

Keywords

risk factors,, clinically relevant pancreatic fistula,, pancreaticoduodenectomy

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.

Interventions

PROCEDUREpancreaticoduodenectomy procedure

Pancreaticoduodenectomy operation

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
clinically relevant post operative pancreatic fistula10 daysA 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026