Comparing two methods for preventing pancreatic fistula after surgery
Impact of Reinforced Pancreaticojejunostomy With or Without Tissue Adhesive Glue Modified Cyanoacrylate (Glubran 2) Following Pancreaticoduodenectomy, Randomized Controlled Clinical Trial.
This study is testing if using a special glue during pancreatic surgery can help prevent serious leaks in the pancreas compared to the usual method for people having surgery for cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya) |
| Trial ID | NCT06756074 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of reinforced pancreaticojejunostomy using a tissue adhesive (glubran 2) compared to the standard technique without the adhesive in patients undergoing pancreaticoduodenectomy for cancer. The research focuses on reducing the incidence of pancreatic fistula, a serious complication following this type of surgery. By analyzing long-term clinical outcomes, the study seeks to determine the best method for preventing this complication. The use of tissue adhesives is explored for their potential to enhance surgical techniques and improve patient recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing pancreaticoduodenectomy for cancer who can provide informed consent.
Not a fit: Patients who are unfit for surgery due to severe medical conditions or have inoperable tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the occurrence of pancreatic fistula, improving recovery and outcomes for patients undergoing pancreatic surgery.
How similar studies have performed: While the use of tissue adhesives in surgical procedures is gaining traction, this specific approach to pancreaticojejunostomy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All the patients undergoing pancreaticoduodenectomy for cancer * Patients able to give their informed consent Exclusion Criteria: * Unfit patients for surgery due to severe medical illness. * Inoperable patients by imaging studies, irresectable tumors after laparotomy or diagnostic laparoscopy. * Presence of distant metastasis . * Patients refused to participate in the study.
Where this trial is running
Minya
- Liver and GIT hospital / Minia university — Minya, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.