Minimally invasive versus open pancreato-duodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): an international multicenter patient-blinded randomized controlled trial - DIPLOMA-2 trial

Academisch Medisch Centrum0 个研究点目标入组 290 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•Age at least 18 years;
•Indication for elective pancreatoduodenectomy for a tumor located in the
•pancreatic head, distal bile duct, duodenum or ampulla of Vater; in the second
•phase of the study (after 288 patients are included) only patients with a
•malignant tumor of the pancreatic head or distal bile duct will be eligible for
•Both minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy
•are technically feasible for radical resection, according to the local
•treatment team;
•Pre-operative multiphase CT scan showing no signs of vascular involvement (3D
•reconstruction optional).
•o In case of (suspected) malignancy: maximum 28 days old CT-scan available.
•Fit to undergo pancreatoduodenectomy according to the surgeon and
•anesthesiologist
•Written informed consent

•- A second cancer requiring resection during the same procedure - Chronic
•pancreatitis as indication (including Groove pancreatitis) - Any vascular
•involvement (portal vein, superior mesenteric vein, superior mesenteric artery,
•coeliac artery or hepatic artery) - Pregnancy - Body mass index >35 kg/m2 -
•Participation in another study with interference of study outcomes - Not able
•or willing to complete the (quality-of-life) questionnaires Hybrid procedures
•in which the resection is performed via a laparoscopic approach and the
•reconstruction via an open approach are not allowed in this study.

发起方