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Cyrotherapy vs. APC in GAVE

Primary Purpose

Watermelon Stomach

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cryotherapy
Argon Plasma Coagulation
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Watermelon Stomach focused on measuring Watermelon Stomach, Cryotherapy, Argon Plasma Coagulation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo CLinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Cryotherapy

Argon Plasma Coagulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Endoscopic response will constitute the secondary outcome

Full Information

First Posted
December 21, 2007
Last Updated
January 5, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00587405
Brief Title
Cyrotherapy vs. APC in GAVE
Official Title
Prospective Randomized Study of Cryotherapy Versus Argon Plasma Coagulation Therapy for Treatment Of Watermelon Stomach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Watermelon Stomach
Keywords
Watermelon Stomach, Cryotherapy, Argon Plasma Coagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Cryotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Argon Plasma Coagulation
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Argon Plasma Coagulation
Intervention Description
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 Measure Information:
Title
the proportion of clinical responders (no overt and hematological evidence of ongoing bleeding) and non-responders
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Endoscopic response will constitute the secondary outcome
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Able to give informed consent Age > 18 years Exclusion Criteria: Endoscopic or histological findings inconsistent with WS Known coagulopathy (INR > 2), severe thrombocytopenia (platelet count < 50,000), or bleeding diathesis Endoscopic treatment of WS within the past month Unable or unwilling to give informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis M Wongkeesong, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo CLinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cyrotherapy vs. APC in GAVE

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