NCT07230509 Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate
| NCT ID | NCT07230509 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Minia University |
| Condition | Pancreaticoduodenectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-12-01 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2025-12-01 with a primary completion date of 2027-12-01.
⚠ 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
This randomized controlled trial investigates the safety and efficacy of injecting N-butyl-2- cyanoacrylate (Histoacryl®) into the pancreatic parenchyma during pancreaticoduodenectomy (PD) to enhance the security of the pancreaticojejunostomy (PJ) anastomosis and reduce postoperative pancreatic fistula (POPF) rates.
Eligibility Criteria
Inclusion Criteria: * Patients undergoing pancreaticoduodenectomy for malignant lesions meeting the curative treatment intent in accordance with clinical guidelines. * Soft pancreatic texture. * Small main pancreatic duct diameter (\<3 mm). * Informed consent obtained. Exclusion Criteria: * Known hypersensitivity to cyanoacrylate or Lipiodol®. * Extremely hard, fibrotic pancreas. * Significant pancreatitis involving the pancreatic remnant. * Active infection at the surgical site. * Uncontrolled coagulopathy. * 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. * Patients requiring left, central or total pancreatectomy or other palliative surgery. * Pregnant or breastfeeding women. * Patients with serious mental disorders. * Patients with vascular invasion and requiring vascular resection. * Patients refused to participate in the study.
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07230509 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreaticoduodenectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07230509 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07230509 currently recruiting?
Yes, NCT07230509 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07230509 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07230509 clinical trial?
NCT07230509 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 90 participants.