Cyrotherapy vs. APC in GAVE
Phase 2
Completed
- Conditions
- Watermelon Stomach
- Interventions
- Procedure: cryotherapyProcedure: Argon Plasma Coagulation
- Registration Number
- NCT00587405
- Lead Sponsor
- Mayo Clinic
- Brief Summary
To see if either method of treatment for Watermelon Stomach shows better results
- Detailed Description
Watermelon stomach (WS) is endoscopically recognized by characteristic stripes of angioectasias involving primarily the antrum, and causes transfusion-dependent anemia in the majority of patients. Current endoscopic treatment options, including argon plasma coagulation (APC) Endoscopic cryotherapy is a novel technique that has the potential to safely and more effectively treat WS by virtue of its mechanism of injury and mode of application.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Confirmed WS at endoscopy that is associated with significant anemia (Hb < 10 g/dl) and/or overt bleeding (melena, hematochezia or hematemesis) and/or blood transfusions within the past 6 months
- Able to give informed consent
- Age > 18 years
Exclusion Criteria
- Endoscopic or histological findings inconsistent with WS
- Known coagulopathy (INR > 2), severe thrombocytopenia (platelet count < 50,000), or bleeding diathesis
- Endoscopic treatment of WS within the past month
- Unable or unwilling to give informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 cryotherapy Cryotherapy 2 Argon Plasma Coagulation Argon Plasma Coagulation
- Primary Outcome Measures
Name Time Method the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders 6 months
- Secondary Outcome Measures
Name Time Method Endoscopic response will constitute the secondary outcome 6 months
Trial Locations
- Locations (1)
Mayo CLinic
🇺🇸Rochester, Minnesota, United States