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The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.
The primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we
Prospective Randomized Clinical Trials between Laparoscopy-assisted Proximal Gastrectomy and Laparoscopy-assisted Total Gastrectomy.
LAPG reconstruction: double tract reconstruction (3 anastomosis, intracorporeal Roux-en Y esophago-jejunostomy, extracorporeal gastro-jejunostomy 10cm below esophago-jejunostomy,extracorporeal jejuno-jejunostomy 20cm below gastro-jejunostomy)
LATG reconstruction: intracorporeal Roux-en Y esophago-jejunostomy
Primary end point : incidence of reflux esophagitis after operation
Sample Size : LAPG 97 cases, LATG 97 cases (p1=0.018 p2=0.018, a=0.05, b=0.80) Non-inferiority test, non-inferior margin (delta) : 0.05. Sample size calculated by our MRCC(Medical Research Collaborating Center, http://mrcc.snubh.org)
Study duration : 48 months (enrollment 36months, follow-up 12months)
Reflux esophagitis evaluation methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAPG | Active Comparator | LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group |
|
| LATG | Active Comparator | LATG : laparoscopy-assisted total gastrectomy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopy-assisted gastrectomy | Procedure | Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of reflux esophagitis | Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score | postoperative 3 month |
| Rate of reflux esophagitis | Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score | postoperative 6 month |
| Rate of reflux esophagitis | Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score | postoperative 12 month |
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Inclusion Criteria:
Age 20~80
Informed consent
No other malignancies
Proximal gastric cancer met by following conditions
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyung-Ho Kim, M.D., Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Gyenggi | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |