Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy
NCT ID: NCT01433861
Last Updated: 2017-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
7 participants
INTERVENTIONAL
2012-07-31
2012-11-30
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LAPG
LAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group
Laparoscopy-assisted gastrectomy
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy
LATG
LATG : laparoscopy-assisted total gastrectomy group
Laparoscopy-assisted gastrectomy
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy
Interventions
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Laparoscopy-assisted gastrectomy
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Hyung-Ho Kim
Professor
Principal Investigators
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Hyung-Ho Kim, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam, Gyenggi, South Korea
Countries
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Other Identifiers
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SNUBHGS
Identifier Type: -
Identifier Source: org_study_id
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