peri-ampullaire aandoeningen/tumoren/cysten cancer tumor
Conditions
Interventions
Intervention: Minimally invasive pancreatoduodenectomy
Control: Open pancreatoduodenectomy
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age equal or above 18 years • Indication for elective pancreatoduodenectomy because of a malignant, pre-malignant or symptomatic benign disease located in the pancreatic head, distal bile duct, duodenum or ampulla of Vater • The procedure can be performed both laparoscopically and open according to the local surgeon • Fit to undergo pancreatoduodenectomy according to the surgeon and anaesthetist
Exclusion criteria
Exclusion criteria: • A second cancer requiring resection during the same procedure • Administration of neo-adjuvant radiotherapy • Vascular involvement (portal vein, superior mesenteric vein, superior mesenteric artery or hepatic artery) • Pregnancy • Body mass index >35 kg/m2 • Participation in another study with interference of study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: - IL-6 serum levels Phase 3: - Time to functional recovery, defined as: independently mobile (or as mobile as preoperatively), adequate pain control with only oral analgesia, the ability to maintain at least 50% of daily required caloric intake, no intravenous fluid administration, no signs of active infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clavien-Dindo III or higher complications - Individual complications - Mortality - Quality of life - Costs - Other operative outcomes - Other postoperative outcomes | — |
Countries
Netherlands
Outcome results
None listed