Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

NCT ID: NCT07022015

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2026-07-20

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.

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clinically relevant postoperative pancreatic fistula

patients who developed clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

Group Type: OTHER

pancreaticoduodenectomy procedure

Intervention Type: PROCEDURE

Pancreaticoduodenectomy operation

Interventions

pancreaticoduodenectomy procedure

Pancreaticoduodenectomy operation

Intervention Type: PROCEDURE

Other Intervention Names

PD

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Saleh K Saleh, MD

Role: CONTACT

salehkhairy@mu.edu.eg

01201765401 ext. +2

Facility Contacts

Saleh K Saleh

Role: primary

salehkhairy@mu.edu.eg

01201765401 ext. +2

Other Identifiers

1438/2025

Identifier Type: -

Identifier Source: org_study_id