Minimally invasive versus open pancreatoduodenectomy (surgery to remove the head of the pancreas, duodenum, gallbladder and other nearby tissues) for premalignant and malignant disease
- Conditions
- Pancreatoduodenectomy for premalignant and malignant diseaseSurgery
- Registration Number
- ISRCTN27483786
- Lead Sponsor
- Amsterdam University Medical Centers
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37828593/ (added 16/10/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 288
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall postoperative morbidity and mortality, measured in terms of the comprehensive complication index (CCI), representing the accumulative morbidity up to 90 days after surgery, scored using the Clavien-Dindo classification for complications
- Secondary Outcome Measures
Name Time Method