Cyrotherapy vs. APC in GAVE

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587405
First received: December 21, 2007
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention Phase
Watermelon Stomach
Procedure: cryotherapy
Procedure: Argon Plasma Coagulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Endoscopic response will constitute the secondary outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2007
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Cryotherapy
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587405

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

Additional Information:
No publications provided

Responsible Party: Louis Michel WongKeeSong, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587405     History of Changes
Other Study ID Numbers: 2261-05
Study First Received: December 21, 2007
Last Updated: April 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Watermelon Stomach
Cryotherapy
Argon Plasma Coagulation

Additional relevant MeSH terms:
Gastric Antral Vascular Ectasia
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Angiodysplasia
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014