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Although Laparoscopic gastrectomy for both early and locally advanced gastric cancer has gained popularity, the use of laparoscopic total gastrectomy for proximal advanced gastric cancer is still limited to some experienced surgeons, because of its technical difficulties in D2 lymph node dissection and anastomoses.
Some retrospective and cohort studies regarding laparoscopic total gastrectomy with lymph node dissection suggested the likelihood of application of laparoscopic surgery for proximal gastric cancer. However, there has been no randomized clinical trial comparing results of laparoscopic total gastrectomy with D2 lymph node dissection with open conventional surgery.
Therefore, we aimed to verify the efficacy of laparoscopic total gastrectomy with D2(D2-10) lymph node dissection, technical and oncologic safety compared with open surgery via multicenter randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic group | Experimental | Arm Description: Laparoscopic radical total gastrectomy with D2 (or D2-#10) lymph node dissection |
|
| Open group | Active Comparator | Open radical total gastrectomy with D2 (or D2-#10) lymph node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3 year relapse-free survival | Non-inferiority of 3 year relapse-free survival rate after laparoscopic radical total gastrectomy and lymphadenectomy for locally advanced gastric cancer comparing with open conventional surgery. The "event" of relapse-free survival is defined as "recurrence" after 4 weeks of operation. The "censoring" is defined as non-traceable patient who cannot be confirmed with recurrence or patient who are alive without recurrence until follow-up. The "relapse-free survival time" is defined as the time from surgery to "event" or "censoring". | 3 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 3 year overall survival rate | 3 years after surgery | |
| 5 year relapse-free and overall survival | 5 years after surgery | |
| Morbidity (early period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Woo Jin Hyung, MD, PhD | Contact | +82-2-2228-2100 | wjhyung@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Yonsei University College of Medicine, Seoul, Korea | Recruiting | Seoul | 120-752 | South Korea |
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2-arm randomized controlled study
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|
| Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach | Procedure |
|
|
| from Operation day until POD 21 |
| Morbidity (late period) | from POD (Post-Operative Day) 22 until 5 years after surgery |
| Mortality | death with any cause | at POD 30 |
| Mortality | death with any cause | at POD 90 |
| Quality of life(EORTC QLQ-C30) | Quality of life measured by EORTC QLQ-C30(Version 3) The questionnaire was designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life). | at POD 21 |
| Quality of life(EORTC QLC STO22) | Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss). | at POD 21 |
| Quality of life(EORTC QLQ-C30) | Quality of life measured by EORTC QLQ-C30(Version 3) | 3 months after surgery |
| Quality of life(EORTC QLC STO22) | Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss). | 3 months after surgery |
| Quality of life(EORTC QLQ-C30) | Quality of life measured by EORTC QLQ-C30(Version 3) | 12 months after surgery |
| Quality of life(EORTC QLC STO22) | Quality of life measured by EORTC QLC STO22. The EORTC QLQ-STO 22 module contains 22 items in a similar layout and response format to the EORTC QLQ-C30. The hypothesised scale structure of the module consists of five scales (dysphagia, eating restrictions, pain, reflux and anxiety) and three single items (dry mouth, body image and hair loss). | 12 months after surgery |
| 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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