NCT07022015 Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy
| NCT ID | NCT07022015 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minia University |
| Condition | Pancreas Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2026-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-06-20 with a primary completion date of 2026-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07022015 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreas Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07022015 currently recruiting?
Yes, NCT07022015 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07022015 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07022015 clinical trial?
NCT07022015 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 100 participants.
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