Robotic vs Open Pancreatoduodenectomy
Recruiting · NCT06981273 · Interventional (participants receive a specific treatment) · Lead sponsor: Hospital del Mar
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Pancreatic surgery, specifically pancreatoduodenectomy (PD), is a complex procedure often required for patients with pancreatic or other periampullary cancers. In recent years, minimally invasive techniques have become more popular, especially robotic-assisted surgery. However, there are limited studies comparing robotic surgery to traditional open surgery. This is a national, multicenter study in Spain comparing the outcomes of robotic versus open pancreatoduodenectomy (PD). The main goal is to assess complications within 90 days after surgery. This study is important because it will provide evidence on which approach is safer and more effective for patients. The study follows a \*\*prospective, randomized, and multicenter design\*\*, meaning patients are assigned to either robotic or open surgery randomly, and multiple hospitals are involved. The study will include all eligible patients undergoing planned PD surgery, either by robotic or open technique. To be included in the study, patients must meet these conditions: * Be \*\*18 years or older\*\*. * Require \*\*planned PD surgery\*\*. * Sign an \*\*informed consent form\*\*. Who Cannot Participate? Patients will \*\*not\*\* be included if they: * \*\*Refuse the procedure\*\*. * Have \*\*uncertainty about vascular involvement\*\*. * Have a severe health condition classified as \*\*ASA IV\*\* (high-risk for surgery). The main outcome measured will be the \*\*Comprehensive Complication Index (CCI), a standardized way to assess post-surgical complications. Additional factors being studied include: * \*\*Clinical outcomes\*\* during and after surgery. * \*\*Quality of life\*\* assessments. * \*\*Surgical costs\*\*. * \*\*Hospital stay duration\*\*. * \*\*Need to switch from robotic to open surgery\*\*. * \*\*Need for additional surgery (reoperations)\*\*. * \*\*Hospital readmissions\*\*. Where Is the Study Being Conducted? The study is being conducted in \*\*ten major hospitals across Spain\*\*: 1. Hospital del Mar, Barcelona 2. Hospital Balmis, Alicante 3. Hospital Vall d'Hebron, Barcelona 4. Arnau de Vilanova, Lleida 5. Joan XXIII, Tarragona 6. Hospital Sant Pau, Barcelona 7. HM Sanchinarro, Madrid 8. Hospital Rio Hortega, Valladolid How Long Will the Study Last? The study will take \*\*two years\*\* to complete, and patients will be followed for \*\*three years\*\* after surgery to track long-term outcomes. Why Is This Study Important for Patients? For patients undergoing PD, this study will provide essential information about the risks and benefits of robotic versus open surgery. The findings will help doctors determine the best surgical approach, leading to improved safety, faster recovery, and better long-term health outcomes. If you are a patient facing this type of surgery, participating in this study could contribute to valuable medical knowledge while ensuring that you receive a carefully monitored treatment plan.
Who can take part
Inclusion criteria
- Age 18 years or older.
- Patients requiring planned pancreatoduodenectomy (robotic or open).
- Signed informed consent to participate in the study.
Exclusion criteria
- Patients who refuse the procedure.
- Uncertainty about vascular involvement that could affect resectability.
- Poor general health status (American Society of Anesthesiologists \[ASA\] classification IV).
- Pancreatitis
Where it is running
1 location listed.
- Hospital del Mar - Barcelona, Spain