Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT01433861
Brief 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
Study:
NCT01433861
Study Brief:
Protocol Section:
NCT01433861