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

Study Overview
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Brief Summary
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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

Detailed Description
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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 Ambulatory 24hr-pH esophageal holter monitoring for acid reflux DISIDA scan for bile reflux Endoscopic evaluation (Grading according to LA classification) Visick score (subjective symptoms) EORTC sto 22 and GIQLI evaluation (Quality of Life) Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test) Upper gastrointestinal study Gastric emptying scan

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopy-assisted gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20 80 Informed consent No other malignancies Proximal gastric cancer met by following conditions Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to proper muscle depth (cT2) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1) Exclusion Criteria: If patients is only suitable to total gastrectomy, he will be excluded.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LAPG<br>LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group | Procedure: Laparoscopy-assisted gastrectomy<br>* Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy<br>|
| Active Comparator: LATG<br>LATG : laparoscopy-assisted total gastrectomy group | Procedure: Laparoscopy-assisted gastrectomy<br>* Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, proximal gastrectomy, total gastrectomy, laparoscopy, reflux esophagitis, double tract reconstruction