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Clinical Trials/NCT04198337
NCT04198337
Recruiting
Not Applicable

Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)

Chinese University of Hong Kong1 site in 1 country30 target enrollmentAugust 1, 2014
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ConditionsGastric GIST

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric GIST
Sponsor
Chinese University of Hong Kong
Enrollment
30
Locations
1
Primary Endpoint
Complete resection of GIST
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST

Detailed Description

To evaluate the clinical safety and efficacy of endoscopic full thickness resection (EFTR) for treatment of gastric GIST. A total of 30 patients will be recruited

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Philip Wai Yan CHIU

Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • •Age \> 18 and ≤ 80
  • •Gastric submucosal tumors located at cardia, lesser curvature and antrum
  • •Size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic

Exclusion Criteria

  • •Patients who are considered as unfit for general anesthesia
  • •ASA class ≥ IV or moribund patients
  • •Gastric submucosal tumors located at greater curvature and fundus

Outcomes

Primary Outcomes

Complete resection of GIST

Time Frame: 30 days

Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins

Secondary Outcomes

  • Hospital stay(30 days)
  • Perioperative mortality(30 days)
  • Adverse event rate(30 days)
  • Histolology assessment(30 days)
  • technical success in complete resection(1 day)

Study Sites (1)

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