대한복강경위장관연구회

KLASS 03

KLASS trial > KLASS 03

ClinicalTrials.gov Identifier: NCT01584336

Full Name	Prospective Multi-center Study of Laparoscopy-assisted Total Gastrectomy for Clinical Stage I Gastric Cancer (KLASS-03)

Study Design:	Study Type: Prospective, Multi-center, Phase 2, Interventional (Clinical Trial) Estimated Enrollment :168 participants Intervention Model: Single Group Assignment Primary endpoint: The incidence of postoperative morbidity and mortality [Time Frame: 1 month] Eligibility Criteria: 20 Years to 80 Years (Adult, Older Adult) Inclusion Criteria: Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy range of age; over 20 years to under 80 years preoperative stage: cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC) The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction the gastric cancer which is not included the indication of the endoscopic mucosal dissection ECOG (Eastern Cooperative Oncology Group) performance status; 0 and 1 ASA (American Society of Anesthesiology) score; 1, 2, 3 Written informed consent Exclusion Criteria: The patient who shows distant metastasis under preoperative examination The patient with medical history for upper abdominal surgery with open method in the past The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past (remnant stomach cancer) The patient with double cancer synchronous or metachronous within 5 years Enlarged lymph nodes of the splenic hilum in the preoperative evaluation The patient who has been enrolled other clinical study within 6 months Vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy

Study Design:

Study Type: Prospective, Multi-center, Phase 2, Interventional (Clinical Trial) Estimated Enrollment :168 participants
Intervention Model: Single Group Assignment
Primary endpoint: The incidence of postoperative morbidity and mortality [Time Frame: 1 month]
Eligibility Criteria: 20 Years to 80 Years (Adult, Older Adult)
Inclusion Criteria:

Pathologically diagnosed as gastric adenocarcinoma under preoperative endoscopic biopsy
range of age; over 20 years to under 80 years
preoperative stage: cT1N0M0, cT1N1M0, cT2N0M0 (7th UICC)
The patient who is needed the total gastrectomy because the upper margin of cancer is located between upper 1cm and lower 5cm to esophagogastric junction
the gastric cancer which is not included the indication of the endoscopic mucosal dissection
ECOG (Eastern Cooperative Oncology Group) performance status; 0 and 1
ASA (American Society of Anesthesiology) score; 1, 2, 3
Written informed consent

Exclusion Criteria:

The patient who shows distant metastasis under preoperative examination
The patient with medical history for upper abdominal surgery with open method in the past
The patient with medical history for distal gastrectomy due to benign or malignant gastric disease in the past (remnant stomach cancer)
The patient with double cancer synchronous or metachronous within 5 years
Enlarged lymph nodes of the splenic hilum in the preoperative evaluation
The patient who has been enrolled other clinical study within 6 months
Vulnerable patients who lacks mental capacity and are pregnant or planning a pregnancy

Principle Investigator	Gyu Seok Cho (Soonchunhyang University College of Medicine) E-mail: gschogs@schmc.ac.kr

Chronology	2012. 10	Study Start
Chronology	2014. 02	Actual Primary Completion (Final data collection date for primary outcome measure)

PUBLICATED ARTICLES	1. Hyung WJ, Yang HK, Han SU, Lee YJ, Park JM, Kim JJ, Kwon OK, Kong SH, Kim HI, Lee HJ, Kim W, Ryu SW, Jin SH, Oh SJ, Ryu KW, Kim MC, Ahn HS, Park YK, Kim YH, Hwang SH, Kim JW, Cho GS. A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03. Gastric Cancer. 2019 Jan;22(1):214-222. doi: 10.1007/s10120-018-0864-4. Epub 2018 Aug 20. PMID: 30128720.

PUBLICATED ARTICLES

1. Hyung WJ, Yang HK, Han SU, Lee YJ, Park JM, Kim JJ, Kwon OK, Kong SH, Kim HI, Lee HJ, Kim W, Ryu SW, Jin SH, Oh SJ, Ryu KW, Kim MC, Ahn HS, Park YK, Kim YH, Hwang SH, Kim JW, Cho GS. A feasibility study of laparoscopic total gastrectomy for clinical stage I gastric cancer: a prospective multi-center phase II clinical trial, KLASS 03. Gastric Cancer. 2019 Jan;22(1):214-222. doi: 10.1007/s10120-018-0864-4. Epub 2018 Aug 20. PMID: 30128720.