Short-Term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial)

D. J. Park, Y. W. Kim, H. K. Yang, K. W. Ryu, S. U. Han, H. H. Kim, W. J. Hyung, J. H. Park, Y. S. Suh, O. K. Kwon, H. M. Yoon, W. Kim, Y. K. Park, S. H. Kong, S. H. Ahn, H. J. Lee

Research output: Contribution to journalArticlepeer-review

26 Citations (Scopus)

Abstract

Background: There remain concerns about the safety and functional benefit of laparoscopic pylorus-preserving gastrectomy (LPPG) compared with laparoscopic distal gastrectomy (LDG). This study evaluated short-Term outcomes of a randomized clinical trial (RCT) comparing LPPG with LDG for gastric cancer. Methods: The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS)-04 trial was an investigator-initiated, open-label, parallel-Assigned, superiority, multicentre RCT in Korea. Patients with cT1N0M0 cancer located in the middle third of the stomach at least 5 cm from the pylorus were randomized to undergo LPPG or LDG. Participants, care givers and those assessing the outcomes were not blinded to group assignment. Outcomes were 30-day postoperative morbidity rate and death at 90 days. Results: Some 256 patients from nine institutions were randomized (LPPG 129 patients, LDG 127 patients) between July 2015 and July 2017 and outcomes for 253 patients were analysed. Postoperative complications within 30 days were seen in 19.3 and 15.5 per cent in the LPPG and LDG groups respectively (P = 0·419). Postoperative pyloric stenosis was observed in nine (7.2 per cent) and two (1·5 per cent) patients in the LPPG and LDG groups (P = 0·026) respectively. In multivariable analysis higher BMI was a risk factor for postoperative complications (odds ratio 1·17, 95 per cent c.i. 1·04 to 1·32; P = 0·011). Death at 90 days was zero in both groups. Conclusion: Postoperative complications and mortality was comparable in patients undergoing LPPG and LDG. Registration number: NCT02595086 (http://www.clinicaltrials.gov).

Original languageEnglish
Pages (from-to)1043-1049
Number of pages7
JournalBritish Journal of Surgery
Volume108
Issue number9
DOIs
Publication statusPublished - 2021 Sept 1

Bibliographical note

Publisher Copyright:
© 2021 The Author(s). Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved.

All Science Journal Classification (ASJC) codes

  • Surgery

Fingerprint

Dive into the research topics of 'Short-Term outcomes of a multicentre randomized clinical trial comparing laparoscopic pylorus-preserving gastrectomy with laparoscopic distal gastrectomy for gastric cancer (the KLASS-04 trial)'. Together they form a unique fingerprint.

Cite this