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Laparoscopic versus open distal pancreatectomy for symptomatic benign, premalignant and malignant disease


- candidate number21931
- NTR NumberNTR5188
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-apr-2015
- Secondary IDsNL52031.018.15 
- Public TitleLaparoscopic versus open distal pancreatectomy for symptomatic benign, premalignant and malignant disease
- Scientific TitleLaparoscopic versus open distal pancreatectomy for symptomatic benign, premalignant and malignant disease
- ACRONYMLEOPARD
- hypothesisTime to functional recovery is shorter after laparoscopic than after open distal pancreatectomy
- Healt Condition(s) or Problem(s) studiedPancreas disease
- Inclusion criteria- Age equal or above 18 years;
- Indication for elective distal pancreatectomy (+ / - splenectomy) because of proven or suspected symptomatic benign, premalignant or malignant disease of the distal pancreas;
- Tumor meeting the Yonsei criteria
- Fit to undergo distal pancreatectomy according to the surgeon and anaesthetist.
- Exclusion criteria- Tumor or cyst larger than 8 cm;
- Distal pancreatectomy is not the sole procedure; - Chronic pancreatitis (according to the M-ANNHEIM criteria;
- Pregnancy;
- 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 10-apr-2015
- planned closingdate10-apr-2017
- Target number of participants102
- InterventionsLaparoscopic distal pancreatectomy
- Primary outcomeTime to functional recovery
- Secondary outcomeOther operative and postoperative outcomes
- Timepoints1. Baseline
2. Operation
3. 2 weeks postoperatively
4. 1 month postoperatively
5. 3 months postoperatively
- Trial web sitewww.leopard-trial.nl
- 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)
J&J Medical B.V.
- Publications
- Brief summary
- Main changes (audit trail)Exlusion criteria NEW:
- Patient recieved radiotherapy because of pancreatic cancer
- RECORD9-apr-2015 - 19-jul-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl