title: 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.
authors.affiliation: McGill University Heath Center, McGill University, Montreal, Canada. Electronic address: jeffrey.barkun@muhc.mcgill.ca.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Barkun
authors.affiliation: Department of Surgery, General Surgery, Baylor College of Medicine, Houston, USA.
authors.forename: William
authors.initials: W
authors.lastname: Fisher
authors.affiliation: University of Washington Department of Surgery, Department of Health Services, Surgical Outcomes Research Center, Seattle, USA.
authors.forename: Giana
authors.initials: G
authors.lastname: Davidson
authors.affiliation: Ageo Central General Hospital, Saitama, Japan.
authors.forename: Go
authors.initials: G
authors.lastname: Wakabayashi
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: Besselink
authors.affiliation: Temple University Health System, Inc., Temple University - Lewis Katz School of Medicine, Philadelphia Academy of Surgery, Philadelphia, USA.
authors.forename: Henry
authors.initials: H
authors.lastname: Pitt
authors.affiliation: National Pancreas Foundation, USA.
authors.forename: Jane
authors.initials: J
authors.lastname: Holt
authors.affiliation: Surgery Division of General Surgery, Barnes-Jewish Hospital, VA Medical Center - St. Louis - John Cochran Division, St. Louis, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Strasberg
authors.affiliation: The University of Pennsylvania, Philadelphia, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Vollmer
authors.affiliation: Emory University, Atlanta, USA.
authors.forename: David
authors.initials: D
authors.lastname: Kooby
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D032921:Consensus; D003625:Data Collection; D004059:Diffusion of Innovation; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects; D010180:Pancreatectomy / Q000009:adverse effects / Q000379:methods*; D016577:Pancreaticoduodenectomy / Q000009:adverse effects / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D065287:Robotic Surgical Procedures / Q000009:adverse effects; D016896:Treatment Outcome