Gastric GISTEFTRNCT04198337
Endoscopic Full Thickness Resection for Gastric GIST
A study testing Endoscopic Full Thickness Resection in people with Gastric GIST, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric GIST
- What is being tested?
- Endoscopic Full Thickness Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2014to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Surgery, Faculty of Medicine, The Chinese University of Hong Kong
Hong Kong, Outside of US & Canada, 00000
Philip WY Chiu, MD, 85235053952, philipchiu@surgery.cuhk.edu.hk
Man Yee Yung, 85235052956, myyung@surgery.cuhk.edu.hk
About this study
Official title: Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST
Read the 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
- Conditions
- Gastric GIST
- Being tested
- Endoscopic Full Thickness Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Full Thickness ResectionProcedure or surgery
Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Endoscopic Full Thickness Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resection of GIST
Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins
Measured: 30 days
Secondary outcomes (5)
Adverse event rate
Adverse event as defined by presence of either postoperative bleeding or leakage after closure
Measured: 30 days
Perioperative mortality
Death within 30 days after procedure
Measured: 30 days
Histolology assessment
Histology outcome as defined by any involvement of the tumor margins after resection
Measured: 30 days
Hospital stay
Length of stay in hospital
Measured: 30 days
technical success in complete resection
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Aug 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric GISTStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Wai Yan CHIU, Chinese University of Hong Kong
- Investigators
- Philip Wai Yan Chiu, MD, FRCSEd, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198337
- Sponsor's protocol ID
- CREC 2014.293-T
- Acronym
- EFTR
- Status last verified
- Nov 2023
- First submitted
- 12 Dec 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)
- ClinicalTrials.gov ID
- NCT04198337
- Acronym / sponsor ID
- EFTR / CREC 2014.293-T
- Conditions
- Gastric GIST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Full Thickness Resection | Experimental | Procedure: Endoscopic Full Thickness ResectionResection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Full Thickness ResectionEndoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure | Procedure or surgery | Endoscopic Full Thickness Resection |
Primary outcome
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
5 secondary outcomes
Adverse event rate
Time frame: 30 days
Perioperative mortality
Time frame: 30 days
Histolology assessment
Time frame: 30 days
Hospital stay
Time frame: 30 days
technical success in complete resection
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric GIST
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
KQB198 in Combination With Imatinib in Participants With Advanced/Metastatic GIST in 1st Line Setting (SynerGIST-1st Line)
GIST - Gastrointestinal Stromal Tumor, GIST
Active, not recruitingPhase 2
Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)
Locally Advanced Gastrointestinal Stromal Tumor, Locally Advanced Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Wai Yan Chiu, MD, FRCSEd principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Full Thickness Resection in people with Gastric GIST, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Wai Yan Y Chiu, MD, FRCSEd (+85235053952, philipchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resection of GIST (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.