Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

NCT07022015 | Recruiting DMC

• 1 other identifier: 1438/2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.

Conditions

Pancreas Cancer; Pancreas Neoplasm; Pancreatic Fistula; Pancreas Adenocarcinoma; Periampullary Cancer; Periampullary Carcinoma; Resectable Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of 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 (1)

Clinically relevant postoperative pancreatic fistula

OTHER

patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

Procedure: pancreaticoduodenectomy procedure

Interventions

pancreaticoduodenectomy procedure PROCEDURE

Pancreaticoduodenectomy operation

Also known as: PD

Clinically relevant postoperative pancreatic fistula

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
• Patients meeting the curative treatment intent in accordance with clinical guidelines:
• No evidence of metastasis.
• Radiological non-involvement of superior mesenteric vein \& portal vein.
• American Society of Anesthesiologists (ASA) scores I \& II.
• Patients aged \> 18 years.
• Ability to understand and the willingness to sign a written informed consent document
• Agreement to complete the study

You may not qualify if:

• Unfit patients for surgery due to severe medical illness.
• Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
• Irresectable tumors in diagnostic laparoscopy.
• History of other malignant disease.
• Pregnant or breast-feeding women.
• Patients with serious mental disorders.
• Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data.
• Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis
• Patients refused to participate in the study.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 15, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)