The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE December 12, 2019
First Posted Date  ICMJE December 13, 2019
Last Update Posted Date November 7, 2023
Actual Study Start Date  ICMJE August 1, 2014
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2019)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • Adverse event rate [ Time Frame: 30 days ]
    Adverse event as defined by presence of either postoperative bleeding or leakage after closure
  • Perioperative mortality [ Time Frame: 30 days ]
    Death within 30 days after procedure
  • Histolology assessment [ Time Frame: 30 days ]
    Histology outcome as defined by any involvement of the tumor margins after resection
  • Hospital stay [ Time Frame: 30 days ]
    Length of stay in hospital
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Full Thickness Resection for Gastric GIST
Official Title  ICMJE Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric GIST
Intervention  ICMJE Procedure: Endoscopic Full Thickness Resection
Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure
Study Arms  ICMJE 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
Intervention: Procedure: Endoscopic Full Thickness Resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philip Wai Yan Y Chiu, MD, FRCSEd +85235053952 philipchiu@surgery.cuhk.edu.hk
Contact: Man Yee Yung +35052956 myyung@surgery.cuhk.edu.hk
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04198337
Other Study ID Numbers  ICMJE CREC 2014.293-T
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Philip Wai Yan CHIU, Chinese University of Hong Kong
Original Responsible Party Philip Wai Yan Chiu, Chinese University of Hong Kong, Professor
Current Study Sponsor  ICMJE Chinese University of Hong Kong
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Wai Yan Chiu, MD, FRCSEd Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP