Cyrotherapy vs. APC in GAVE

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Related Clinical Trial

Brief Title

Cyrotherapy vs. APC in GAVE

Official Title

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

Brief Summary

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

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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders

Secondary Outcome

 Endoscopic response will constitute the secondary outcome

Condition

Watermelon Stomach

Intervention

cryotherapy

Study Arms / Comparison Groups

 1
Description:  Cryotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

December 2007

Completion Date

April 2010

Primary Completion Date

March 2010

Eligibility 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.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Louis M Wongkeesong, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00587405

Organization ID

2261-05


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

Louis M Wongkeesong, MD, Principal Investigator, Mayo Clinic


Verification Date

April 2010