title: Laparoscopic Distal Pancreatectomy for Pancreatic Ductal Adenocarcinoma: Time for a Randomized Controlled Trial? Results of an All-inclusive National Observational Study.
abstract: OBJECTIVE
  The aim of this study is to compare at a national level, the early and long-term outcome of distal pancreatectomy (DP) performed by laparoscopy (LapDP) or open surgery (OpenDP) for pancreatic ductal adenocarcinoma (PDAC).
  
  
  BACKGROUND
  LapDP is feasible and safe for benign conditions but its use for PDAC is controversial.
  
  
  METHODS
  French healthcare databases were screened to identify all patients who had undergone LapDP or OpenDP for PDAC between 2007 and 2012. Endpoints were (i) 90-day mortality, (ii) morbidity, (iii) transfusion rate, (iv) length of hospital stay (LOS), and (v) long-term survival. Logistic regression and adjusted Cox models were used to compare LapDP and OpenDP with regard to these outcomes. Confounders included (i) patients' characteristics; (ii) associated surgical procedures; and (iii) characteristics of the hospital. Performance of the resulting models was determined by the area under the receiver operating characteristic (ROC) curve.
  
  
  RESULTS
  Over the 6-year period, there were 2753 operations for PDAC: 2406 OpenDP and 347 LapDP (12.6%). The overall 90-day mortality rate was 5.2%; median LOS was 15 days, and median survival was 38 months. LapDP was not correlated with 90-day mortality but was associated with reduced pleuropulmonary morbidity (odds ratio (OR) 0.73, P = 0.028), blood transfusion (OR 0.44, P = 0.001), and LOS (P = 0.042), and was associated with increased survival (P = 0.0007).
  
  
  CONCLUSIONS
  LapDP has not been adopted widely for PDAC. The early and long-term results of LapDP as currently practiced are as good as those of OpenDP. The next step in the evaluation of LapDP should be a randomized controlled trial (RCT), but such a trial is likely to suffer from insufficient recruitment.
authors.affiliation: *Department of HPB and Digestive Surgery, CHU Rennes Université de Rennes 1, Rennes, France †Department of Medical Informatics, Hôpital Beaujon, Clichy, France ‡Department of HPB and Pancreatic Surgery, Hôpital Beaujon, Clichy, Assistance Publique Hôpitaux de Parisd, Université Paris 7, Clichy, France §Department of Oncological Surgery, Institut Paoli Calmettes, Marseille, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Sulpice
authors.forename: Olivier
authors.initials: O
authors.lastname: Farges
authors.forename: Nathalie
authors.initials: N
authors.lastname: Goutte
authors.forename: Noelle
authors.initials: N
authors.lastname: Bendersky
authors.forename: Safi
authors.initials: S
authors.lastname: Dokmak
authors.forename: Alain
authors.initials: A
authors.lastname: Sauvanet
authors.forename: Jean Robert
authors.initials: JR
authors.lastname: Delpero
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D021441:Carcinoma, Pancreatic Ductal / Q000401:mortality / Q000601:surgery; D005240:Feasibility Studies; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D010535:Laparoscopy / Q000379:methods; D010180:Pancreatectomy / Q000379:methods; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000601:surgery; D012189:Retrospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome