박신후 (고려대학교 의과대학, 을지대학교 의과대학)

한빛사논문

조회182

박신후Shin-Hoo Park

고려대학교 의과대학, 을지대학교 의과대학

Int. J. Surg., May 06 2024, | https://doi.org/10.1097/JS9.0000000000001543 Totally laparoscopic versus laparoscopy-assisted distal gastrectomy: the KLASS-07, a randomized controlled trial

Park, Shin-Hoo MD^a,b,c; Lee, Chang-Min PhD^a,d; Hur, Hoon PhD^e; Min, Jae-Seok PhD^a,b,f; Ryu, Seung Wan PhD^g; Son, Young-Gil PhD^g; Chae, Hyun Dong PhD^h; Jeong, Oh PhDⁱ; Jung, Mi Ran PhDⁱ; Choi, Chang In PhD^j; Song, Kyo Young PhD^k; Lee, Han Hong PhD^k; Kim, Ho Goon PhD^l; Jee, Ye Seob PhD^m; Hwang, Sun-Hwi PhDⁿ; Lee, Moon-Soo PhD^o; Kim, Kwang Hee PhD^p; Seo, Sang Hyuk MD^p; Jeong, In Ho PhD^q; Son, Myoung Won PhD^r; Kim, Chang Hyun PhD^s; Yoo, Moon-Won MD^t; Oh, Sung Jin PhD^u; Kim, Jeong Goo PhD^v; Hwang, Seong Ho MD^v; Choi, Sung IL PhD^w; Yang, Kyung Sook PhD^x; Huang, Hua PhD^y,z; Park, Sungsoo PhD^a,b

^aDepartment of Surgery, Korea University College of Medicine, Seoul, Republic of Korea

^bDivision of Foregut Surgery, Korea University Anam Hospital, Seoul, Republic of Korea

^cDepartment of Surgery, Uijeongbu Eulji Medical Centre, Eulji University College of Medicine, Republic of Korea

^dDepartment of Surgery, Korea University Ansan Hospital, Ansan, Republic of Korea

^eDepartment of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea

^fDepartment of Surgery, Dongnam Institute of Radiological and Medical Sciences, Cancer Centre, Busan, Republic of Korea

^gDepartment of Surgery, Keimyung University Dongsan Medical Centre, Daegu, Republic of Korea

^hDepartment of Surgery, Catholic University of Daegu School of Medicine, Daegu, Korea

ⁱDepartment of Surgery, Chonnam National University Medical School, Jeollanam-do, Republic of Korea

^jDepartment of Surgery, Pusan National University School of Medicine, Pusan, Republic of Korea

^kDepartment of Surgery, Seoul St Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

^lDepartment of Surgery, Chonnam National University Medical School, Gwangju, Korea

^mDepartment of Surgery, Dankook University College of Medicine, Cheonan, Korea

ⁿPusan National University School of Medicine, Research Institute for Convergence of Biomedical Science and Technology, Department of Surgery, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea

^oDepartment of Surgery, Eulji University Hospital, Daejeon, Republic of Korea

^pDepartment of Surgery, Busan Paik Hospital, Inje University, Republic of Korea

^qDepartment of Surgery, Jeju National University School of Medicine, Jeju, Korea

^rDepartment of Surgery, Soonchunhyang University Hospital Cheonan, Cheonan, Korea

^sDepartment of Surgery, Incheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea

^tDepartment of Surgery, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Republic of Korea

^uDepartment of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea

^vDepartment of Surgery, Daejeon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

^wDepartment of Surgery, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea

^xDepartment of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea

^yDepartment of Gastric Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China

^zDepartment of Oncology, Shanghai Medical College, Fudan University, Shanghai, China

Drs Shin-Hoo Park and Chang-Min Lee: have contributed equally to this work and should be considered first coauthors.

^*Corresponding author: Sungsoo Park PhD

Abstract

Backgrounds: Strong evidence is lacking as no confirmatory randomized controlled trials (RCTs) have compared the efficacy of totally laparoscopic distal gastrectomy (TLDG) with laparoscopy-assisted distal gastrectomy (LADG). We performed an RCT to confirm if TLDG is different from LADG.

Methods: The XXXXX trial is a multicentre, open-label, parallel-group, phase III, RCT of 442 patients with clinical stage I gastric cancer. Patients were enrolled from 21 cancer care centers in South Korea between January 2018 and September 2020 and randomized to undergo TLDG or LADG using blocked randomization with a 1:1 allocation ratio, stratified by the participating investigators. Patients were treated through R0 resections by TLDG or LADG as the full analysis set of the XXXXX trial. The primary endpoint was morbidity within postoperative day 30, and the secondary endpoint was QoL for 1 year. This trial is registered at ClinicalTrials.gov (NCT XXXXXXXX).

Results: 442 patients were randomized (222 to TLDG, 220 to LADG), and 422 patients were included in the pure analysis (213 and 209, respectively). The overall complication rate did not differ between the two groups (TLDG vs. LADG: 12.2% vs. 17.2%). However, TLDG provided less postoperative ileus and pulmonary complications than LADG (0.9% vs. 5.7%, P=0.006; and 0.5% vs. 4.3%, P=0.035, respectively). The QoL was better after TLDG than after LADG regarding emotional functioning at 6 months, pain at 3 months, anxiety at 3 and 6 months, and body image at 3 and 6 months (all P<0.05). However, these QoL differences were resolved at 1 year.

Conclusions: The XXXXX trial confirmed that TLDG is not different from LADG in terms of postoperative complication but has advantages to reduce ileus and pulmonary complications. TLDG can be a good option to offer better QoL in terms of pain, body image, emotion, and anxiety at 3-6 months.

논문정보

형식Research article
게재일2024년 05월 (BRIC 등록일 2024-05-21)
연구진국내(교신)+국외 연구진
분야 의약학 > 응용의학

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