Multicenter prospective randomized controlled trial of comparing laparoscopic proximal gastrectomy and laparoscopic total gastrectomy for upper third early gastric cancer (KLASS-05).

Authors

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Do Joong Park

Seoul National University Bundang Hospital, Seongnam-Si, Korea, Republic of (South)

Do Joong Park , Hyung-Ho Kim , Sang Uk Han , Woo Jin Hyung , Sun-Hwi Hwang , Hoon Hur , Han-Kwang Yang , Hyuk-Joon Lee , Hyoung-Il Kim , Young Woo Kim , Seong-Ho Kong , Han Hong Lee , Youngkyu Park , In Seob Lee , Beom Su Kim , Young-Joon Lee , Ji-Ho Park , Yun-Suhk Suh , Sang-Hoon Ahn

Organizations

Seoul National University Bundang Hospital, Seongnam-Si, Korea, Republic of (South), Department of Surgery, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea, Republic of (South), Ajou University School of Medicine, Suwon, Korea, Republic of (South), Yonsei University College of Medicine, Seoul, Korea, Republic of (South), Pusan National University Yangsan Hospital, Pusan, Korea, Republic of (South), Seoul National University College of Medicine, Seoul, Korea, Republic of (South), Yonsei University Severance Hospital, Seoul, Korea, Republic of (South), National Cancer Center, Goyang, Korea, Republic of (South), Department of Surgery, Seoul National University Hospital, Seoul, Korea, Republic of (South), Department of General Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea, Uijeongbu, Korea, Republic of (South), Chonnam National University Hwasun Hospital, Hwasun, Korea, Republic of (South), Asan Medical Center, Seoul, Korea, Republic of (South), Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South), Gyengsang National University Hospital, Jinju, Korea, Republic of (South), Gyengsang National University College of Medicine, Jinju, Korea, Republic of (South), Seoul National University Hospital, Seoul, Korea, Republic of (South), Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea

Research Funding

Pharmaceutical/Biotech Company

Background: Proximal gastrectomy (PG) is rarely performed for upper third early gastric cancer (EGC) because of postoperative reflux esophagitis. Recently, PG with double tract reconstruction was introduced and reported to have a reflux of approximately the same frequency as total gastrectomy (TG) with esophagojejunostomy. PG has several theoretical advantages over TG but has not yet been proven in randomized controlled trial. This study aimed to provide scientific evidence of laparoscopic PG with double tract reconstruction as a standard procedure for proximal EGC. Methods: The present trial is multicenter, prospective, randomized, controlled trial with superiority design. A total of 138 patients with upper third cT1N0M0 gastric adenocarcinoma are randomized to laparoscopic PG with double tract reconstruction and laparoscopic TG with esophagojejunostomy. Patients are enrolled for two years and followed up for two years. Primary co-endpoints are hemoglobin change and vitamin B12 cumulative supplement quantity after 2 years of operation. We used the alpha-split method to set the hemoglobin to 4% and vitamin B12 to 1% for alpha. The sample size needed was 62 patients for each arm. Accounting for 10% follow-up loss, the enrollment of 69 patients in each group was required. Secondary endpoints are prevalence rate of postoperative reflux esophagitis, morbidity and mortality, quality of life 2-year after operations, relapse-free survival, and overall survival. Nineteen investigators from 10 institutes participated in this trial. The first patient was enrolled on October 27, 2016 and we completed the patient enrollment on September 17, 2018. Clinical trial information: NCT02892643

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Abstract Details

Meeting

2019 Gastrointestinal Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session A: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT02892643

Citation

J Clin Oncol 37, 2019 (suppl 4; abstr TPS184)

DOI

10.1200/JCO.2019.37.4_suppl.TPS184

Abstract #

TPS184

Poster Bd #

N16

Abstract Disclosures