Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula

NCT05687825 | Completed

• 1 other identifier: SVU/MED/SUR011/4/23/4/612
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fistula

Keywords

risk factors,; clinically relevant pancreatic fistula,; pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• clinically relevant post operative pancreatic fistula

  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

  10 days

Study Arms (2)

Clinically relevant postoperative pancreatic fistula

patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

Procedure: pancreaticoduodenectomy procedure

No clinically relevant postoperative pancreatic fistula

patients who did not develop clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

Procedure: pancreaticoduodenectomy procedure

Interventions

pancreaticoduodenectomy procedure PROCEDURE

Pancreaticoduodenectomy operation

Clinically relevant postoperative pancreatic fistula; No clinically relevant postoperative pancreatic fistula

Eligibility Criteria

• Age: 20 Years - 80 Years
• Gender Eligibility Details: more than 20 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all consecutive patients who were treated with a pancreaticoduodenectomy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Qena faculty of Medicine, South Valley University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed A Omar, M.D.

  General Surgery Department, Faculty of Medicine, South Valley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of surgery

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: August 1, 2017
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)