SPAIN Trial Comparing Open vs Robotic Pancreatoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Complication Index
研究概览
简要总结
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**:
- Hospital del Mar, Barcelona
- Hospital Balmis, Alicante
- Hospital Vall d'Hebron, Barcelona
- Arnau de Vilanova, Lleida
- Joan XXIII, Tarragona
- Hospital Sant Pau, Barcelona
- HM Sanchinarro, Madrid
- 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.
详细描述
Introduction
Pancreatoduodenectomy (PD), commonly known as the Whipple procedure, is a complex surgical procedure used to treat pancreatic, bile duct, and duodenal diseases, including cancer. Traditionally, this surgery has been performed using an open approach (PDA), but recent advancements in minimally invasive techniques have introduced the robotic approach (PDR) as a potential alternative.
Minimally invasive robotic surgery may offer benefits such as reduced blood loss, shorter hospital stays, and potentially lower complication rates. However, there is limited high-quality evidence comparing the outcomes of robotic PD versus open PD. This national, multicenter, randomized clinical trial aims to provide clear answers by analyzing postoperative complications and overall patient outcomes.
Primary Objective
Evaluate postoperative complications using the CCI within 90 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Patients requiring planned pancreatoduodenectomy (robotic or open).
- •Signed informed consent to participate in the study.
排除标准
- •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
研究组 & 干预措施
Robotic
Robotic pancreatoduodenectomy is performed under the robotic da Vinci system where at least the pancreatic and biliary anastomosis is performed throughout this approach.
干预措施: Robotic pancreatoduodenectomy (Procedure)
Open
open pancreatoduodenectomy is performed through a laparotomy following the standard criteria for this type of surgery.
干预措施: open pancreatoduodenectomy (Procedure)
结局指标
主要结局
Complication Index
时间窗: up to 90 days after surgery
Morbidity is assessed using the Complication Index (CCI) (www.assesssurgery.com). The primary objective is to measure CCI®, which tracks complications up to 90 days after surgery.
次要结局
- Cost effectiveness(3 months after surgery)
- Tumor clearance(until the end of the study)
- operative time(during the surgery)
- Blood loss(during the surgery)
- Conversion to open surgery(during surgery)
- EORTC QLQ-C30(before and after surgery at 30 and 90 days)
- Pancreatic Fistula(after surgery up to 90 days from operation)
- QoR-15(after surgery at 30 and 90 days)