Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- microscopically radical resection rate
研究概览
简要总结
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.
Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints.
Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.
Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
Control: Open distal pancreatectomy
详细描述
Rationale: Several systematic reviews have suggested superior short term outcomes after minimally invasive distal pancreatectomy (MIDP) as compared to open distal pancreatectomy (ODP) for benign and pre-malignant disease. In the literature and in a recent pan-European survey, about one third of pancreatic surgeons expressed concerns regarding the oncologic safety (i.e. radical resection, lymph node retrieval and survival) of MIDP in pancreatic cancer. Most surgeons stated that a randomized trial assessing oncologic safety in MIDP vs ODP for pancreatic cancer is needed.
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.
Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints.
Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.
Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •≥ 18 years;
- •Elective indication for distal pancreatectomy for proven or suspected PDAC;
- •Upfront (without induction / down-sizing radio- and/or chemotherapy) resectable PDAC in the pancreatic body or tail;
- •The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team;
- •The patient is fit to undergo both open and minimally invasive distal pancreatectomy
排除标准
- •score of American society of anaesthesiologists (ASA) >3;
- •A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria);
- •Second malignancy necessitating resection during the same procedure;
- •Distant metastases (M1) including involved distant lymph nodes;
- •Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or portomesenteric vein);
- •Pregnancy;
- •Participation in another study with interference of study outcomes.
- •Cystic lesion having undergone malignant transformation
- •the celiac trunk should be 5mm clear from tumor
研究组 & 干预措施
ODP
open distal pancreatectomy
干预措施: open distal pancreatectomy (Procedure)
MIDP
minimally invasive distal pancreatectomy
干预措施: minimally invasive distal pancreatectomy (Procedure)
结局指标
主要结局
microscopically radical resection rate
时间窗: 1 day
R0, \>1mm
次要结局
- postoperative outcomes(1 day)
- survival(3 years)
- Operative time(1 day)
- Intraoperative blood loss(1 day)
- lymph node retrieval(1 day)
- intraoperative outcomes(1 day)
- specimen size(1 day)
- Specimen length(1 day)
- margin(1 day)