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NCT00587405 Clinical Trial

Cyrotherapy vs. APC in GAVE

Watermelon Stomach Clinical Trial

Official title:
Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00587405
Other study ID # 2261-05
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 21, 2007
Last updated January 5, 2016
Start date December 2007
Est. completion date April 2010

Study information
Verified date April 2010
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To see if either method of treatment for Watermelon Stomach shows better results

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 information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

1. 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

2. Able to give informed consent

3. Age > 18 years

Exclusion Criteria:

1. Endoscopic or histological findings inconsistent with WS

2. Known coagulopathy (INR > 2), severe thrombocytopenia (platelet count < 50,000), or bleeding diathesis

3. Endoscopic treatment of WS within the past month

4. Unable or unwilling to give informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• cryotherapy
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.
• Argon Plasma Coagulation
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

Locations
Country Name City State
United States Mayo CLinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders 6 months Yes
Secondary Endoscopic response will constitute the secondary outcome 6 months No

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