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Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Participating Surgeons Prior to this clinical trial, only the surgeons who are considered to have the standardization by review committee participated.
Patients Registration It is required to ensure that the patients meet the inclusion criteria for this clinical trial, are free from any items of exclusion criteria, are explained about the participation in the clinical trial along with the informed consent forms.
After rechecking the patients with the registration check list by accessing the web-based randomized program provided from Seoul National University Bundang Hospital Medical Research Collaborating Center.
Each group 69 patients, total 138 subjects will be enrolled. Randomization The registration randomization should be done with 1:1 ratio for each researcher.
Baseline number (BN) should be provided to the subjects in the order of acquisition of informed consent form. Based on the subjects who are selected as the appropriate subjects in the end, the allocation number (AN) shall be provided in the order of randomized allocation table.
Procedure Operations are performed according to the allocated group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic proximal gastrectomy | Experimental | Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. |
|
| Laparoscopic total gastrectomy | Active Comparator | Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic proximal gastrectomy | Procedure | Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Hemoglobin | from blood sample | up to 2 years postoperatively |
| Vitamin B12 cumulative supplement quantity | from blood sample | up to 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Operative morbidity | Complications occuring after operation | 30 days for early morbidity |
| Operative mortality | Mortality after operation |
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Inclusion Criteria:
Histologically proven adenocarcinoma through endoscopic biopsy Aged 20-80 years old Written signed informed consent No other malignancies Proximal gastric cancer met by following conditions ; Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to mucosa or submucosa (cT1) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis.
Performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale Performance status (PS) of I to III on American Society of Anesthesiologists (ASA) score
Exclusion Criteria:
History of anemia Patients who need total gastrectomy History of pre-operative chemotherapy or radiation therapy for gastric cancer Patients who need combined resection (except cholecystectomy) Presence of other malignancies Prior treatment against systemic inflammatory disease Previous gastric surgery Vulnerable patients (lack of decision-making capacity, pregnant, or breast-feeding women)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soonchunhyang University Bucheon Hospital | Bucheon-si | South Korea | ||||
| Dong-A University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36790808 | Derived | Park DJ, Han SU, Hyung WJ, Hwang SH, Hur H, Yang HK, Lee HJ, Kim HI, Kong SH, Kim YW, Lee HH, Kim BS, Park YK, Lee YJ, Ahn SH, Lee I, Suh YS, Park JH, Ahn S, Park YS, Kim HH. Effect of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction vs Total Gastrectomy on Hemoglobin Level and Vitamin B12 Supplementation in Upper-Third Early Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2256004. doi: 10.1001/jamanetworkopen.2022.56004. | |
| 35534447 |
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|
| Laparoscopic total gastrectomy | Procedure | Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy. |
|
| mortality for 90 days |
| QOL measurement | EORTC C30/STO22 | 6 month, 1 year, 2 year, postoperatively |
| Reflux esophagitis | assessed by Visick score and endoscopic grading according to LA classification | check at every 12 months up to 2 years postoperatively |
| Relapse-free survival | Relapse-free survival | 2 years postoperatively |
| Overall survival | Overall survival | 2 years postoperatively |
| Busan |
| South Korea |
| Dankook University Hospital | Cheonan | South Korea |
| Keimyung University Hospital | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Eulji University Hospital, Deajon | Daejeon | South Korea |
| Chonnam National University Hospital | Hwasun | South Korea |
| National Cancer Center | Ilsan | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Ewha Womans University Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul St. Mary's Hospital | Seoul | South Korea |
| Yeouido St. Mary's Hospital | Seoul | South Korea |
| Yonsei University Severance Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Derived |
| Hwang SH, Park DJ, Kim HH, Hyung WJ, Hur H, Yang HK, Lee HJ, Kim HI, Kong SH, Kim YW, Lee HH, Kim BS, Park YK, Lee YJ, Ahn SH, Lee IS, Suh YS, Park JH, Ahn S, Han SU. Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial. J Gastric Cancer. 2022 Apr;22(2):94-106. doi: 10.5230/jgc.2022.22.e8. |
| 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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