ISRCTN27483786进行中（未招募）未知
Minimally invasive versus open pancreatoduodenectomy for pancreatic and periampullary neoplasms (DIPLOMA-2): an international multicenter patient-blinded randomized controlled trial
Amsterdam University Medical Centers0 个研究点目标入组 288 人开始时间: 2022年1月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 288
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37828593/ (added 16/10/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age at least 18 years
- •2. Indication for elective pancreatoduodenectomy for a tumor located in the pancreatic head, distal bile duct, duodenum or ampulla of Vater
- •3. Both minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy are technically feasible for radical resection, according to the local treatment team
- •4. Pre-operative multiphase CT scan showing no signs of vascular involvement (in case of (suspected) malignancy: maximum 28 days old CT-scan available)
- •5. Fit to undergo pancreatoduodenectomy according to the surgeon and anesthesiologist
- •6. Written informed consent
排除标准
- •1. A second cancer requiring resection during the same procedure
- •2. Chronic pancreatitis as indication (including Groove pancreatitis)
- •3. Any vascular involvement (portal vein, superior mesenteric vein, superior mesenteric artery, coeliac artery or hepatic artery)
- •4. Pregnancy
- •5. Body mass index >35 kg/m²
- •6. Participation in another study with interference of study outcomes
研究者
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