Using biodegradable stents during surgery to prevent complications after pancreas surgery
Intraoperative Biodegradable Stent Placement to Reduce Complications After Pancreatoduodenectomy - Protocol and Statistical Analysis Plan for Randomized, Clinical Trial
This study is testing if using biodegradable stents during pancreas surgery can help prevent complications like leaks after the operation for adults who are having this type of surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Capitol) |
| Trial ID | NCT06205693 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of placing biodegradable stents in the pancreatojejunostomy during pancreatoduodenectomy to prevent postoperative pancreatic fistulas. It is a prospective, randomized, and blinded trial designed to determine if this intervention can safely reduce the risk of pancreatic leakage. The study will involve patients aged 18 and older who are undergoing this specific type of surgery and have provided informed consent. The biodegradable stents used in the trial are designed to degrade over time, minimizing long-term complications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for pancreatoduodenectomy and can provide informed consent.
Not a fit: Patients with a history of thrombo-embolic diseases, bleeding disorders, or those undergoing active immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of pancreatic fistulas, improving recovery outcomes for patients undergoing pancreatoduodenectomy.
How similar studies have performed: While the use of biodegradable stents is a novel approach in this context, similar studies have shown promise in reducing complications in other surgical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients undergoing a pancreatoduodenectomy 2. Patients aged 18 or above 3. Patients who have given an informed consent Exclusion Criteria: 1. Patients who do not or cannot give an informed consent. 2. Patients with at a high risk or with previous history of multiple thrombo-embolic diseases or bleeding disorders. 3. Patients undergoing active immunosuppressive therapy.
Where this trial is running
Copenhagen, Capitol
- Rigshospitalet — Copenhagen, Capitol, Denmark (Recruiting)
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.