Cyrotherapy vs. APC in GAVE

January 5, 2016 updated by: Louis-Michel Wong Kee Song, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Louis M WongKeeSong, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 7, 2008

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2261-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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