Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, proximal gastrectomy, total gastrectomy, laparoscopy, reflux esophagitis, double tract reconstruction
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Laparoscopy-assisted gastrectomy
Type: Procedure
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age 20~80

- Informed consent

- No other malignancies

- Proximal gastric cancer met by following conditions

1. Lesion located on proximal stomach (upper one third)

2. Lesion below 5cm in size

3. Lesion confined to proper muscle depth (cT2)

4. 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.
Location
Seoul National University Bundang Hospital
Seongnam, Gyenggi, Korea, Republic of
Status: Recruiting
Contact: Hyung-Ho Kim, M.D., Ph.D. - +82-10-3079-7095 - hhkim@snubh.org
Start Date
July 2012
Completion Date
December 2015
Sponsors
Seoul National University Bundang Hospital
Source
Seoul National University Bundang Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page