Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy (NCT07022015) | Clinical Trial Compass
RecruitingNot Applicable
Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy
Egypt100 participantsStarted 2025-06-20
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of clinically relevant post operative pancreatic fistula