Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

Leonie Haverkamp,Freek Daams,Richard Van Hillegersberg,Werner A Draaisma ,Donald L Van Der Peet ,Henk H Hartgrink ,Maarten F J Seesing ,Suzanne S Gisbertz ,J Jan B Van Lanschot ,Bas P L Wijnhoven ,Jan H.m.b Stoot ,Henk F Van Stel ,Wobbe O De Steur ,Karel W E Hulsewé ,Jelle P Ruurda ,Misha Luyer ,Marc J Van Det ,I A M J Broeders ,Mark I Van Berge Henegouwen ,Ewout A Kouwenhoven ,Ernst Jan Spillenaar Bilgen ,Miangela M Laclé ,Hylke J F Brenkman ,Jeroen E Rütter ,Grard A P Nieuwenhuijzen

doi:10.1186/s12885-015-1551-z

Abstract

BackgroundFor gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy.MethodsThe study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness.DiscussionIn this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.Trial registration NCT02248519

Highlights

For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment
Surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment, only half of the patients are eligible for surgery with curative intent
Several systematic reviews and meta-analyses have shown an advantage in shortterm outcomes of laparoscopic distal and total gastrectomy compared to open procedures

Summary

Introduction

Surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes It remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. Oncologic outcomes are similar on the short term [7, 8, 10,11,12] These studies are mainly performed in the Asian population in which early gastric cancer is detected at a higher rate due to a screening program.

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