Endoscopic Full Thickness Resection for Gastric GIST

NCT ID: NCT04198337

Last Updated: 2023-11-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Gastric GIST

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic Full Thickness Resection

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

Group Type EXPERIMENTAL

Endoscopic Full Thickness Resection

Intervention Type PROCEDURE

Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure

Interventions

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Endoscopic Full Thickness Resection

Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients who are considered as unfit for general anesthesia
2. ASA class ≥ IV or moribund patients
3. Pregnancy
4. Gastric submucosal tumors located at greater curvature and fundus
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Philip Wai Yan CHIU

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philip Wai Yan Chiu, MD, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, Outside of US & Canada, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Philip Wai Yan Y Chiu, MD, FRCSEd

Role: CONTACT

+85235053952

Man Yee Yung

Role: CONTACT

+35052956

Facility Contacts

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Philip WY Chiu, MD

Role: primary

85235053952

Man Yee Yung

Role: backup

85235052956

Other Identifiers

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CREC 2014.293-T

Identifier Type: -

Identifier Source: org_study_id

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