Abstract
BackgroundObservational 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.MethodsLEOPARD 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.DiscussionThe LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting.Trial registrationDutch Trial Register, NTR5188. Registered on 9 April 2015
Highlights
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
These suggestions were confirmed by several systematic reviews of cohort studies that reported reductions in intraoperative blood loss, blood transfusion, complications, wound infections and shorter hospital stay, and an increased rate of spleen preservation, all in favor of the minimally invasive approach [10, 11]
Age equal to or above 18 years Indication for elective distal pancreatectomy because of proven or suspected left-sided symptomatic benign, premalignant or malignant disease Tumor meeting the Yonsei criteria [22] Sufficiently fit to undergo distal pancreatectomy according to the surgeon and anesthetist
Summary
Design The LEOPARD trial is a randomized controlled, parallelgroup, patient-blinded, multicenter, superiority trial investigating the effectiveness of MIDP versus ODP for treatment of symptomatic benign, premalignant or malignant disease of the distal pancreas in an enhanced recovery setting. Secondary outcomes The secondary outcomes of this trial include operative outcomes (type of approach, vascular tumor involvement, tumor involvement in multiple organs, type of primary and secondary surgeon (resident, fellow or surgical specialist), conversion and reason for conversion, method of pancreatic transection, spleen preservation (including technique: Kimura/Warshaw), vessel resection, intraoperative blood transfusion, administration of somatostatin analogs, intra-operative complications, operative time (from first incision to full skin closure), total duration of the procedure and intraoperative blood loss, type of analgesia), postoperative outcomes (pain management, complications (e.g. postoperative pancreatic fistula, post-pancreatectomy hemorrhage, delayed gastric emptying and surgical site infection), postoperative intervention (radiologic, endoscopic, surgical), postoperative blood transfusion, intensive care unit admission, length of hospital stay, readmission, time to start adjuvant chemotherapy (in the case of malignant disease), mortality and Clavien-Dindo scores of all individual complications), pathology parameters (resected specimen length, tumor size, histopathological diagnosis, resection margins (including transection, anterior circumferential and posterior circumferential margins, in the case of malignancy), lymph node retrieval, tumor-positive lymph node retrieval (in the case of malignancy), neural and vascular tumor invasion), costs (intra-operative and postoperative costs) and quality of life. Participants who do not fulfil the authorship criteria will be listed in PubMed as ‘collaborators’
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