Research considerations in the evaluation of minimally invasive pancreatic resection (MIPR)

Abstract

The IHPBA/AHPBA-sponsored 2016 minimally invasive pancreatic resection (MIPR) conference held on April 20th, 2016 included a session designed to evaluate what would be the most appropriate scientific contribution to help define the increasing role of MIPR internationally. Participants in the conference reviewed the assessment of numerous pertinent scientific designs including randomized controlled trial (RCT), pragmatic international RCT, registry-RCT, non-RCT with propensity matching, and various types of clinical registries including those aiming to create a quality improvement data system or a learning health care system. The strengths and weaknesses of each of these designs, the status of trials which are currently recruiting patients, and pragmatic considerations were evaluated. A recommendation was made to establish a clinical registry to collect data prospectively from around the world to assess current practices and provide a framework for future studies in MIPR.

Comprehensive comparative analysis of cost-effectiveness and perioperative outcomes between open, laparoscopic, and robotic distal pancreatectomy

“…35,36 The MIPR conference determined the need for adequate training and reporting of outcomes. 1,2 The Dutch Pancreatic Group in the Netherlands has formulated a study (LAELAPS-1) for distal pancreatectomy training including video review and proctorship, 37 and have initiated a trial (LEOPARD-1) for surgeons beyond their learning curve, which is the first MIDP vs. ODP randomized-controlled trial. 38,47 At UPMC training is approached with a formal robotic training curriculum and prospective continuous analysis of outcomes.…”

“…[4][5][6][7][8] Additionally, large multicenter analyses of oncologic parameters in LDP and ODP have shown no differences in lymph node retrieval, numbers of positive nodes, or margin positivity. 2,9,10 A recent study by Kantor et al from the National Cancer Data Base (NCDB) echoes these results and shows decreased readmission rates in LDP compared to ODP and equivalent mortality. 11 Our institution compared clinicopathologic and longterm oncologic outcomes after MIDP (LDP and robotic [RDP]) to ODP for pancreatic ductal adenocarcinoma (PDAC) in an intention-to-treat analysis and demonstrated no evidence for inferiority of MIDP compared with ODP in postoperative outcomes or long-term survival.…”

“…The recent growth led to the development of an International State of the Art MIPR Conference in Brazil April 2016 to highlight this important topic. 1,2 Analysis from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Hepato-Pancreato-Biliary (HPB) Collaborative has shown that 44.5% of distal pancreatectomies (DP) are performed using a minimally invasive (MIS) approach. 1 Despite a slower adoption of MIPR compared to MIS colectomy, this percentage of MIS distal pancreatectomies (MIDP) is similar to ACS-NSQIP reported percentage of MIS colectomies of 46.7%.…”

Minimally invasive pancreatoduodenectomy

“…Training, research and cost were specifically addressed in a dedicated session and are reported elsewhere in this issue. [35][36][37]…”

Robotic and laparoscopic surgery of the pancreas: an historical review

“…Furthermore, the collection of this data through high quality randomized controlled studies may not be possible for a wide range of reasons. Problems associated with research in this field were analyzed in detail by Barkun et al [60]. Non-randomized studies may have to be depended upon for data.…”