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Participating Surgeons
Patients Registration
Randomization
Procedure
Adjuvant Treatment
Evaluation of efficacy and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic gastrectomy | Experimental | Laparoscopic subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer. |
|
| Open gastrectomy | Active Comparator | Open subtotal gastrectomy and D2 lymph node dissection are performed for locally advanced gastric cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic gastrectomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 year relapse free survival | In terms of locally advanced gastric cancer, to examine the non-inferiority of disease free sur-vival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Early postoperative complication | Early postoperative complication is defined as the events which occurs with-in postoperative 21 days, extension of hospitalization and rehospitaliation. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name and date of on-set (postoperatively) and treatment for complication. | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| San-Uk Han, M.D., Ph.D. | Department of Surgery, Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery , SOON CHUN HYANG UNIVESITY HOSPITAL | Bucheon-si | South Korea | ||||
| Keimyung University Dongsan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8180768 | Background | Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. | |
| 18948806 | Background | Kim W, Song KY, Lee HJ, Han SU, Hyung WJ, Cho GS. The impact of comorbidity on surgical outcomes in laparoscopy-assisted distal gastrectomy: a retrospective analysis of multicenter results. Ann Surg. 2008 Nov;248(5):793-9. doi: 10.1097/SLA.0b013e3181887516. |
| Label | URL |
|---|---|
| Institutional Review Board, Ajou University Hospital | View source |
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| Open gastrectomy | Procedure |
|
|
|
| Postoperative mortality | It is defined as the death within postoperative 90 days regardless of postoperative reason. If the patient is transferred to other medication institutes with impossible condition for revocery be-fore death, it is regarded as death. | 90 days |
| Late postoperative complication | Late postoperative complication is defined the events which occurs after postoperative 21 days. It is necessary to evaluate the complication. it is required to record complication name and date of on-set (postoperatively) and treatment for complication. | 36 months |
| Postoperative recovery index | Postoperatively, the examiner evaluates the patient's recovery condition (gas exhaust) once a day. Evaluation items for patient's recovery condition: record the meal process once a day and inquire the pain score (10-scored scale) and blood test results during postoperative hospitalization. | 4 weeks |
| Postoperative quality of life | On preoperative, postoperative 3 weeks and postoperative 12 months, both EORTC-C30 and STO22 are analyzed with quality of life by following methods. In case of EORTC-C30, the analysis is undergone by classifying into 5 functional scales (physical, role, emotional, cognitive, and social fungtioning), 3 symptom scales (fatigue, pain and nausea, and vomiting), 1 global health status and 6 single items. | preoperative, 3 weeks, 12 months |
| 3 years overall survival | As one of the secondary endpoints, the overall survival rate in laparoscopic subtotal gastrectomy with D2 lymph node dissection at postoperative 3 years compared with open subtotal gastrectomy with D2 lymph node dissection. The schedule of visit is based on every 3 months for 3 years. If subjects cannot visit every 3 months, the investigator can arrange the schedule. However, enrolled should visit every 6 months for 3 years. | 6, 12, 18, 24, 30 and 36 months |
| Daegu |
| 700-712 |
| South Korea |
| Copyright National Cancer Center | Goyang-si | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | 519-809 | South Korea |
| Incheon St, Mary's Hostpial, The Catholic University of Korea | Incheon | 403-720 | South Korea |
| Dong-A University Hospital | Pusan | 602-715 | South Korea |
| Department of Surgery, Seoul National University BUNDANG Hospital | Seongnam | South Korea |
| Department of Surgery, Seoul National University Hospital | Seoul | 110-799 | South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Yeoeuido St. Mary's Hospital, The Catholic University of Korea | Seoul | 150-713 | South Korea |
| Department of surgery, GANGNAM SEVERANCE HOSPITAL | Seoul | South Korea |
| EWHA Womans university medical center | Seoul | South Korea |
| Ajou University Hospital | Suwon | 443-749 | South Korea |
| 20160637 | Background | Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b. |
| 17978289 | Background | Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252. |
| 35857305 | Derived | Son SY, Hur H, Hyung WJ, Park YK, Lee HJ, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Kim MC, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Yang HK, Han SU; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: 5-Year Outcomes of the KLASS-02 Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):879-886. doi: 10.1001/jamasurg.2022.2749. |
| 32816629 | Derived | Hyung WJ, Yang HK, Park YK, Lee HJ, An JY, Kim W, Kim HI, Kim HH, Ryu SW, Hur H, Kim MC, Kong SH, Cho GS, Kim JJ, Park DJ, Ryu KW, Kim YW, Kim JW, Lee JH, Han SU; Korean Laparoendoscopic Gastrointestinal Surgery Study Group. Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: The KLASS-02-RCT Randomized Clinical Trial. J Clin Oncol. 2020 Oct 1;38(28):3304-3313. doi: 10.1200/JCO.20.01210. Epub 2020 Aug 20. |
| 25939684 | Derived | Hur H, Lee HY, Lee HJ, Kim MC, Hyung WJ, Park YK, Kim W, Han SU. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial. BMC Cancer. 2015 May 5;15:355. doi: 10.1186/s12885-015-1365-z. |
| The Korean Gastric Cancer Association | View source |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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