NCT01433861

Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopy-assisted gastrectomy	Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-09-14
• Last updated: 2017-01-09

Locations

1 site across 1 country: South Korea