Study Stopped
We planed to study later
Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy
PRAPT
Phase III Prospective Randomized Clinical Trial of Laparoscopy-assisted Proximal Gastrectomy (LAPG) and Laparoscopy-assisted Total Gastrectomy (LATG) for Upper Gastric Cancer. (Multicenter Study)
1 other identifier
interventional
7
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
Started Jul 2012
Shorter than P25 for phase_3 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJanuary 9, 2017
January 1, 2017
4 months
September 10, 2011
January 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
LAPG
ACTIVE COMPARATORLAPG : laparoscopy-assisted proximal gastrectomy with double tract reconstruction group
LATG
ACTIVE COMPARATORLATG : laparoscopy-assisted total gastrectomy group
Interventions
Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- If patients is only suitable to total gastrectomy, he will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, Gyenggi, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyung-Ho Kim, M.D., Ph.D.
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 10, 2011
First Posted
September 14, 2011
Study Start
July 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
January 9, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share