Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor (CELSGIST)
Primary Purpose
Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic management, surgery and follow up
Sponsored by
About this trial
This is an interventional treatment trial for Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
Eligibility Criteria
Inclusion Criteria:
- 18-70 years old Chinese;
- Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;
- Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.
Exclusion Criteria:
- Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;
- Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;
- gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;
- The investigator considers that it is not suitable for this test.
Sites / Locations
- Nanfang HospistalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
endoscopic management
follow up
surgery
Arm Description
Outcomes
Primary Outcome Measures
recur or not in 2 years after endoscopic surgical procedure or surgery
Participants will be followed up for 2 years after endoscopic surgical procedure or surgery by endoscope and/or endoscopic ultrasonography.
Secondary Outcome Measures
Full Information
NCT ID
NCT03471273
First Posted
January 19, 2018
Last Updated
March 13, 2018
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shenzhen Hospital of Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03471273
Brief Title
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
Acronym
CELSGIST
Official Title
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shenzhen Hospital of Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endoscopic management
Arm Type
Other
Arm Title
follow up
Arm Type
Other
Arm Title
surgery
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
endoscopic management, surgery and follow up
Intervention Description
endoscopic management, surgery and follow up
Primary Outcome Measure Information:
Title
recur or not in 2 years after endoscopic surgical procedure or surgery
Description
Participants will be followed up for 2 years after endoscopic surgical procedure or surgery by endoscope and/or endoscopic ultrasonography.
Time Frame
2 years after endoscopic surgical procedure or surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-70 years old Chinese;
Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;
Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.
Exclusion Criteria:
Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;
Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;
gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;
The investigator considers that it is not suitable for this test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Bai, Doctor
Phone
15692428926
Email
stellaff@126.com
Facility Information:
Facility Name
Nanfang Hospistal
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Xie, Doctor
Phone
15692428926
Email
stellaff@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
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