Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial
Open Access
- 8 April 2017
- journal article
- research article
- Published by Springer Science and Business Media LLC in Trials
- Vol. 18 (1), 1-10
- https://doi.org/10.1186/s13063-017-1892-9
Abstract
Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. Dutch Trial Register, NTR5188 . Registered on 9 April 2015Funding Information
- Johnson and Johnson (IIS 14-702)
This publication has 44 references indexed in Scilit:
- Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II – Trial): study protocol for a randomised controlled trialTrials, 2012
- Laparoscopy in Combination with Fast Track Multimodal Management is the Best Perioperative Strategy in Patients Undergoing Colonic SurgeryAnnals of Surgery, 2011
- Laparoscopic approach to distal and subtotal pancreatectomy: a clockwise techniqueSurgical Endoscopy, 2011
- Safety, efficacy, and cost-effectiveness of common laparoscopic proceduresSurgical Endoscopy, 2010
- Long-term follow-up of a randomized clinical trial of open versus laparoscopic appendicectomyBritish Journal of Surgery, 2010
- A Multicenter Analysis of Distal Pancreatectomy for Adenocarcinoma: Is Laparoscopic Resection Appropriate?Journal of the American College of Surgeons, 2010
- Laparoscopic-Assisted Versus Open Ileocolic Resection for Crohn??s DiseaseAnnals of Surgery, 2006
- Classification of Surgical ComplicationsAnnals of Surgery, 2004
- Guideline for Prevention of Surgical Site Infection, 1999American Journal of Infection Control, 1999
- Spleen-preserving distal pancreatectomy with conservation of the splenic artery and veinSurgery, 1996