A Phase 2/3 interventional study of cryotherapy and Argon Plasma Coagulation in Watermelon Stomach, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-01-07.
Sponsored by Mayo Clinic · Phase 2/3, Interventional, and Treatment
To see if either method of treatment for Watermelon Stomach shows better results
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.
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Exclusion Criteria:
Cryotherapy
Procedure: cryotherapy
Argon Plasma Coagulation
Procedure: Argon Plasma Coagulation
The Polar Wand device (GI Supply, Wayne, PA) is FDA 510(k) approved for endoscopic tissue ablation in the GI tract. It consists of a portable cryogen-containing unit and a single-use flexible cryogen spray catheter, designed for use with CO2 that is supplied in standard 20-lb cylinders. Controlled delivery of the cryogen is achieved by a foot pedal, and the tip of the catheter is maintained at about 1 cm from the mucosa. A cryogenic spray is applied to all vascular lesions until a whitened appearance of the mucosa is achieved within 3-5 seconds. Affected areas will be 'painted' by the spray catheter starting at the pylorus and sweeping proximally. A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy.
As per current clinical standard, the APC 300 device (ERBE Inc., Marietta, GA) will be used in this study. Targeted ablation of all vascular ectasias as best possible will be performed in standard fashion using an end-firing probe at a setting of 60 W and 2 L/min argon flow rate.A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy
the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders
Time frame: 6 months
Endoscopic response will constitute the secondary outcome
Time frame: 6 months
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Gastric Antral Vascular Ectasia
Mayo Clinic