Endoscopic Full Thickness Resection for Gastric GIST (EFTR)
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ClinicalTrials.gov Identifier: NCT04198337 |
Recruitment Status :
Recruiting
First Posted : December 13, 2019
Last Update Posted : November 7, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric GIST | Procedure: Endoscopic Full Thickness Resection | Not Applicable |
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 |
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
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Procedure: Endoscopic Full Thickness Resection
Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure |
- 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
- 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
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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 |
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
- Pregnancy
- Gastric submucosal tumors located at greater curvature and fundus
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
Contact: Philip Wai Yan Y Chiu, MD, FRCSEd | +85235053952 | philipchiu@surgery.cuhk.edu.hk | |
Contact: Man Yee Yung | +35052956 | myyung@surgery.cuhk.edu.hk |
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 |
Principal Investigator: | Philip Wai Yan Chiu, MD, FRCSEd | Chinese University of Hong Kong |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |