KLASS 04
KLASS trial > KLASS 04
ClinicalTrials.gov Identifier | NCT02595086(RTC)
| FULL NAME |
Multicenter randomized controlled trial comparing laparoscopic pylorus preserving gastrectomy (LPPG) versus laparoscopic distal gastrectomy (LDG) for the middle third early gastric cancer |
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| STUDY DESIGN |
Multicenter, Prospective randomized controlled trial Primary endpoint: Incidence of Dumping syndrome, assessed by Sigstad score (≥7) at 1 year postoperatively Estimated sample size – 256 patients 
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| PRINCIPLE INVESTIGATOR |
Hyuk-Joon Lee (Seoul National University College of Medicine) e-mail: appe98@snu.ac.kr |
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| CHRONOLOGY | 2014.06.12 | Approval of KLASS-04 by KLASS review committee |
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| 2014.07.30 | 1st investigator meeting of KLASS-04 was held at Seoul National University Hospital | |
| 2014.12.23 | Protocol of KLASS-04 was discussed and approved at 1st steering committee of KLASS-04 | |
| 2015.06.11 | First approval of investigator for KLASS-04 by LPPG video review at 2nd steering committee of KLASS-04 (8 surgeons) | |
| 2015.07.01 | 1st patient was enrolled at Seoul National University Hospital | |
| 2017.07.31 | All patients were enrolled (256/256) by 16 surgeons from 9 institutes | |
| 2020.07.31 | Last follow up was finished | |
| 2021.09.27 | Short-term outcome was published in British Journal of Surgery | |
| 2025.04.01 | Long-term outcome was published in Annals of Surgery |
| PUBLICATED ARTICLES |
1. Park DJ, Kim YW, Yang HK, Ryu KW, Han SU, Kim HH, Hyung WJ, Park JH, Suh YS, Kwon OK, Yoon HM, Kim W, Park YK, Kong SH, Ahn SH, Lee HJ. 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). Br J Surg. 2021 Sep 27;108(9):1043-1049. doi: 10.1093/bjs/znab295. PMID: 34487147. |
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| PHOTO |
1st investigator meeting of KLASS-04 at SNUH (2014.07.30)
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