NCT07132541 Saleh's Technique for Pancreaticojejunostomy (Pancreatic Parenchymal Injection of N-butyl-2-cyanoacrylate)
| NCT ID | NCT07132541 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Minia University |
| Condition | Pancreaticoduodenectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-25 |
| Primary Completion | 2026-08-25 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-08-25 with a primary completion date of 2026-08-25.
⚠ 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 study 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 NCT07132541 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 NCT07132541 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07132541 currently recruiting?
Yes, NCT07132541 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07132541 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07132541 clinical trial?
NCT07132541 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 30 participants.