Trial Information

Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)

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

1. Ambulatory 24hr-pH esophageal holter monitoring for acid reflux

2. DISIDA scan for bile reflux

3. Endoscopic evaluation (Grading according to LA classification)

4. Visick score (subjective symptoms)

5. EORTC sto 22 and GIQLI evaluation (Quality of Life)

6. Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test)

7. Upper gastrointestinal study

8. Gastric emptying scan