Cyrotherapy vs. APC in GAVE

Overview

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

Full Title of Study: “Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

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.

Interventions

  • 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.
  • Procedure: 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

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Cryotherapy
  • Active Comparator: 2
    • Argon Plasma Coagulation

Clinical Trial Outcome Measures

Primary Measures

  • the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders
    • Time Frame: 6 months

Secondary Measures

  • Endoscopic response will constitute the secondary outcome
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Louis-Michel Wong Kee Song, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Louis M Wongkeesong, MD, Principal Investigator, Mayo Clinic

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