Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistu
The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-P
| Condition(s) | Pancreatoduodenectomy, Clinically Relevant Postoperative Pancreatic Fistula, Internal Biodegradable Pancreatic Stent |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF). Patients undergoing PD will be randomized into two arms: * arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis * arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis The rate of occurrence of CR-POPF will be compared between the two arms. |
| Who can participate | Inclusion Criteria: * Age ≥18 * Patients who undergo pancreatoduodenectomy (PD) * Informed Consent Exclusion Criteria: * Previous distal pancreatectomy * Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score \< 7) |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Ospedale San Raffaele |
| Locations | Milan, Milan, Italy |
| Start date | 2023-01-25 |
| NCT ID | NCT05668260 |
| Official listing | https://clinicaltrials.gov/study/NCT05668260 |