Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial

Abstract

Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC.

Materials and methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set.

Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups.

Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

Trial registration: ClinicalTrials.gov Identifier: NCT02892643.

Keywords: Diagnosis; Laparoscopy; Surgery; Treatment.

Conflict of interest statement

Dr. Woo Jin Hyung received grants from Medtronic and Green Cross Pharma during the study. Dr. Han-Kwang Yang received grants from Stryker during the study. Dr. Hyung-Ho Kim received grants from Olympus Korea during the study period. Dr. Hoon Hur reported receiving speaker honoraria from Johnson & Johnson Medical during the conduct of the study and grants from AstraZeneca and Dong-A ST. Dr. Do Joong Park reported receiving grants from Medtronic and Daewoong Pharmaceutical during the study. Dr. Sang-Uk Han received grants from Jeil Pharmaceutical, Ethicon Endo-Surgery, and Johnson & Johnson during the study. Dr. Young-Kyu Park received grants from Ethicon Endo-Surgery and Novomics during the conduct of the study. No other disclosures were reported.

Copyright © 2022. Korean Gastric Cancer Association.

Figures

Fig. 1. Flow diagram.

LPG-DTR = laparoscopic proximal gastrectomy with double-tract reconstruction; LTG = laparoscopic total gastrectomy with Roux-en-Y reconstruction.