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Minimally invasive versus open pancreatoduodenectomy


- candidate number24064
- NTR NumberNTR5689
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mrt-2016
- Secondary IDsNL54453.018.15 
- Public TitleMinimally invasive versus open pancreatoduodenectomy
- Scientific TitleMinimally invasive versus open pancreatoduodenectomy: a multicenter randomized controlled phase 2 trial
- ACRONYMLEOPARD-2 phase 2
- hypothesisMinimally invasive pancreatoduodenectomy is as safe as open pancreatoduodenectomy
- Healt Condition(s) or Problem(s) studiedPancreas, Pancreas disease
- 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- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-mrt-2016
- planned closingdate29-jan-2018
- Target number of participants40
- Interventions- Laparoscopic pancreatoduodenectomy
- Open pancreatoduodenectomy
- Primary outcomeSafety parameters and IL-6 serum levels
- Secondary outcomeOther operative and postoperative outcomes
- Timepoints- Baseline
- Operation
- 2 weeks postoperatively
- 1 month postoperatively
- 3 months postoperatively
- Trial web sitehttp://www.dpcg.nl/projecten/leopard-2.html
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD Thijs de Rooij
- CONTACT for SCIENTIFIC QUERIESMD PhD Marc G.H. Besselink
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)7-mei-2017 - MT
Inclusion of phase 2 is completed on 20-12-2016, the data safety monitoring board allowed the start of phase 3 on 29-01-2017. Primary outcome of phase 3 is time to functional recovery. Patients included in phase 2 are also included in phase 3. Inclusion and exclusion criteria for phase 2 and phase 3 are equal. Target number of patients is 136 (94 additional patients) and planned closingdate is 29-01-2018.

8-mei-2017 MT: replaced laparoscopic by minimally invasive in title and hypothesis.

Inclusion criteria:
The procedure can be performed both laparoscopically and open according to the local surgeon, replaced by, The procedure can be performed both minimally invasive and open according to the local surgeon

Intervention:
Laparoscopic pancreatoduodenectomy, replaced by, minimally invasive pancreatoduodenectomy
- RECORD2-mrt-2016 - 14-mei-2017


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