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Endoscopic Full Thickness Resection for Gastric GIST (EFTR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04198337
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Philip Wai Yan CHIU, Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Gastric GIST Procedure: Endoscopic Full Thickness Resection Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
Actual Study Start Date : August 1, 2014
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Endoscopic Full Thickness Resection
Resection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop
 Procedure: Endoscopic Full Thickness Resection
Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Adverse event rate [ Time Frame: 30 days ]
    Adverse event as defined by presence of either postoperative bleeding or leakage after closure

  2. Perioperative mortality [ Time Frame: 30 days ]
    Death within 30 days after procedure

  3. Histolology assessment [ Time Frame: 30 days ]
    Histology outcome as defined by any involvement of the tumor margins after resection

  4. Hospital stay [ Time Frame: 30 days ]
    Length of stay in hospital

  5. technical success in complete resection [ Time Frame: 1 day ]
    Technical success defined by complete endoscopic resection, closure of the defect and delivery of the specimen per orally without need of conversion to laparoscopic surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198337


Contacts
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Contact: Philip Wai Yan Y Chiu, MD, FRCSEd +85235053952 philipchiu@surgery.cuhk.edu.hk
Contact: Man Yee Yung +35052956 myyung@surgery.cuhk.edu.hk

Locations
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China, Outside Of US & Canada
Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong Recruiting
Hong Kong, Outside Of US & Canada, China, 00000
Contact: Philip WY Chiu, MD    85235053952    philipchiu@surgery.cuhk.edu.hk   
Contact: Man Yee Yung    85235052956    myyung@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Philip Wai Yan Chiu, MD, FRCSEd Chinese University of Hong Kong
More Information
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Responsible Party: Philip Wai Yan CHIU, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04198337    
Other Study ID Numbers: CREC 2014.293-T
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: November 7, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No