Using an external stent to prevent complications after pancreatic surgery
The Impact of External Pancreatic Drainage During Pancreaticojejunostomy Following Pancreaticoduodenectomy in Cases of Soft Pancreas
This study tests whether using an external stent during pancreatic surgery can help prevent complications like pancreatic fistulas in patients with a soft pancreas.
Quick facts
| Phase | Not applicable |
|---|---|
| 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 | NCT06743516 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of external pancreatic duct drainage in preventing pancreatic fistula after pancreaticoduodenectomy, particularly in patients with a soft pancreas. Participants will be randomly assigned to either receive an external stent during their surgery or not. The study aims to evaluate the long-term clinical outcomes and potential benefits of this intervention, including reduced hospital stays and improved quality of life. The risks associated with stent placement will also be assessed to ensure a balanced understanding of the intervention's impact.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing pancreaticoduodenectomy with a confirmed soft pancreas texture.
Not a fit: Patients with a hard or fibrotic pancreas or those with severe uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of pancreatic fistula and improve recovery outcomes for patients undergoing pancreatic surgery.
How similar studies have performed: While the use of external stents in similar contexts has been explored, this specific approach is novel and aims to provide new insights into managing pancreatic fistula.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing pancreaticoduodenectomy (Whipple procedure) for various indications (e.g., pancreatic cancer, ampullary cancer, etc.). * Patients with a confirmed soft pancreas texture, as determined intraoperatively by the surgeon. Exclusion Criteria: * Patients with a hard or fibrotic pancreas, as determined intraoperatively by the surgeon. * Patients with severe uncontrolled comorbidities (e.g., uncontrolled diabetes, severe cardiovascular disease, renal failure). * Pregnancy or lactation.
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 Khairy, 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.