Cyrotherapy vs. APC in GAVE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00587405
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : January 7, 2016
Information provided by (Responsible Party):
Louis-Michel Wong Kee Song, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Watermelon Stomach Procedure: cryotherapy Procedure: Argon Plasma Coagulation Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach
Study Start Date : December 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
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.

Active Comparator: 2
Argon Plasma Coagulation
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

Primary Outcome Measures :
  1. the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Endoscopic response will constitute the secondary outcome [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00587405

United States, Minnesota
Mayo CLinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Louis M Wongkeesong, MD Mayo Clinic

Additional Information:
Responsible Party: Louis-Michel Wong Kee Song, Principal Investigator, Mayo Clinic Identifier: NCT00587405     History of Changes
Other Study ID Numbers: 2261-05
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: April 2010

Keywords provided by Louis-Michel Wong Kee Song, Mayo Clinic:
Watermelon Stomach
Argon Plasma Coagulation

Additional relevant MeSH terms:
Gastric Antral Vascular Ectasia
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action