Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Rate of reflux esophagitis
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
LATG
LATG : laparoscopy-assisted total gastrectomy group
Intervention: Laparoscopy-assisted gastrectomy (Procedure)
LAPG
LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group
Intervention: Laparoscopy-assisted gastrectomy (Procedure)
Outcomes
Primary Outcomes
Rate of reflux esophagitis
Time Frame: postoperative 12 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Rate of reflux esophagitis
Time Frame: postoperative 3 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Rate of reflux esophagitis
Time Frame: postoperative 6 month
Comprehesive evaulation by 24hr pH monitoring, DISIDA scan, Endoscopic evaluation according to LA classification and Visick score
Secondary Outcomes
No secondary outcomes reported
Investigators
Hyung-Ho Kim
Professor
Seoul National University Bundang Hospital