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Compares treatment options for Small Size Gastrointestinal Stromal Tumors
Official title RCT of EFTR Versus STER for GIST Treatment
ClinicalTrials.gov ID: NCT07411118
What this study is testing
- What it's testing
- Endoscopic resection has been increasing utilized as the treatment for small size gastrointestinal stromal tumors (GIST), of which the best resection method has not been identified. We aim to compare the outcomes of endoscopic full thickness resection (EFTR) versus submucosal tunnelling endoscopic resection (STER) for clinical small gastric GIST.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Consecutive adult patients age \>=18 and \<=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for...
- Presence of gastric subepithelial tumor on diagnostic upper endoscopy, and
- Diagnostic EUS and CT scan with intravenous contrast suspicious of GIST arising from muscularis propria layer, size with maximum diameter \>=1.0cm...
- Absence of high risk features, including irregular margins, invasion to surrounding organs, lesion hypervascularity, and
- Endoscopic morphology and location deemed feasible with both EFTR and STER by an expert endoscopist, or
You likely can't join if
- Patients with tumors deemed not suitable for endoscopic resection (Either EFTR or STER), due to unfavourable location, high risk morphology, or any...
- Patients with multiple tumors.
- Patients unable or unwilling to provide consent.
- Previous esophageal or gastric surgery.
- Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including...
- Pregnant women or those planning pregnancy or breastfeeding women.
See the full eligibility criteria
- Consecutive adult patients age \>=18 and \<=75 with a clinical diagnosis of gastric GIST who opted for endoscopic resection would be screened for eligibility.
- Presence of gastric subepithelial tumor on diagnostic upper endoscopy, and
- Diagnostic EUS and CT scan with intravenous contrast suspicious of GIST arising from muscularis propria layer, size with maximum diameter \>=1.0cm and \<= 3.5cm, and
- Absence of high risk features, including irregular margins, invasion to surrounding organs, lesion hypervascularity, and
- Endoscopic morphology and location deemed feasible with both EFTR and STER by an expert endoscopist, or
- Histological confirmation of GIST through EUS guided fine needle biopsy (Optional, based on recommendation from guidelines)
- Patients with tumors deemed not suitable for endoscopic resection (Either EFTR or STER), due to unfavourable location, high risk morphology, or any other reasons.
- Patients with multiple tumors.
- Patients unable or unwilling to provide consent.
- Previous esophageal or gastric surgery.
- Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.
- Pregnant women or those planning pregnancy or breastfeeding women.
- Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
- Patients on double anti-platelet agents or anti-coagulation (Warfarin, heparin or other direct oral anticoagulants)
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
- Hong Kong, Hong Kong
- Hyderabad, India
- Osaka, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China; Hong Kong, Hong Kong; Hyderabad, India; Osaka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.