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NCT Number: NCT07022015

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pancreaticoduodenectomy procedure

Procedure

Pancreaticoduodenectomy operation

Other names: PD

Primary outcomes

  1. Incidence of clinically relevant post operative pancreatic fistula

    Time frame: 10 days

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Saleh K Saleh, MD

CONTACT

[email protected]

01201765401 ext. +2

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.

Acronym: POPF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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