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Clinical Trials/NCT04198337
NCT04198337RecruitingNot 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 enrollmentStarted: August 1, 2014Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
Complete resection of GIST
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Endoscopic Full Thickness Resection

Experimental

Resection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop

Intervention: Endoscopic Full Thickness Resection (Procedure)

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Philip Wai Yan CHIU

Professor

Chinese University of Hong Kong

Study Sites (1)

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