Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- COMPOS-panc left score
研究概览
简要总结
The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patient-blinded up to post-operative day 5. Blinded adjudication committee assessing the primary endpoint.
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 at least 18 years;
- •Indication for elective left-sided pancreatectomy, either spleen-preserving or non-preserving (because of proven or suspected left-sided benign or premalignant disease);
- •Both robot-assisted and laparoscopic left-sided pancreatectomy are technically feasible for resection, according to the local treatment team;
- •Fit to undergo left-sided pancreatectomy according to the surgeon and anaesthesiologist;
- •Written informed consent
排除标准
- •Suspected pancreatic ductal adenocarcinoma;
- •Tumor or cyst larger than 8 cm;
- •Required resection or ablation of organs other than pancreas and spleen;
- •Tumor involvement or abutment of major vessels (celiac trunk, mesenteric artery or vena cava);
- •Pregnancy;
- •Body mass index >40 kg/m2;
- •Participation in another study with interference of study outcomes
研究组 & 干预措施
Laparoscopic minimally invasive left-sided pancreatecomy
Laparoscopic minimally invasive left-sided pancreatecomy
干预措施: Laparoscopic minimally invasive left-sided pancreatecomy (Procedure)
Robot-assisted minimally invasive left-sided pancreatecomy
Robot-assisted minimally invasive left-sided pancreatecomy
干预措施: Robot-assisted minimally invasive left-sided pancreatecomy (Procedure)
结局指标
主要结局
COMPOS-panc left score
时间窗: 90 days
The COMPOS-panc left score is a recently developed, severity-weighted composite outcome measure for pancreatic surgery. It combines perioperative and postoperative outcomes into a single composite outcome measure. This score includes the following parameters, measured at 90-days postoperative: unplanned blood transfusion, emergency conversion to open surgery, postoperative pancreatic fistula (POPF), postpancreatectomy hemorrhage (PPH), other complications requiring intervention, multi-organ failure, mortality, length of hospital stay and readmission requiring intervention.
次要结局
- Spleen-preservation rate and spleen-preservation technique(Surgery)
- Pancreatic surgery specific complications(90 days)
- Total hospital-related costs(90 days)
研究者
M.G. Besselink
prof. dr. M.G. Besselink
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)