Predictive Risk Factors For Pancreatic Fistula After Pancreaticoduodenectomy

Study Overview

Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

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.

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 rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. This study aimed 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.

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

PROCEDURE: pancreaticoduodenectomy procedure

1438/2025

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-06-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-06-19
First Submitted that Met QC Criteria 2025-06-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-06-22
First Posted (ACTUAL) 2025-06-15	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Clinically relevant postoperative pancreatic fistula patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy	PROCEDURE: pancreaticoduodenectomy procedure Pancreaticoduodenectomy operation

Participant Group/Arm

Intervention/Treatment

OTHER: Clinically relevant postoperative pancreatic fistula

patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

PROCEDURE: pancreaticoduodenectomy procedure

Pancreaticoduodenectomy operation

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Saleh K Saleh, MD

Phone Number: 01201765401

Email: salehkhairy@mu.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Saleh K Saleh, MD, Minia University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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