Cyrotherapy vs. APC in GAVE - Full Text View

Sponsor:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587405

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 II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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

Arms

Assigned Interventions

1: Active Comparator

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.

2: Active Comparator

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:

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.

Contacts and Locations

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

Contacts

Contact: Louis M Wongkeesong, MD	507-255-8692	wong.louis@mayo.edu
Contact: Kelly T Dunagan	507-255-8692	dunagan.kelly@mayo.edu

Locations

United States, Minnesota
Mayo CLinic	Recruiting
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator:

Louis M Wongkeesong, MD

Mayo Clinic

More Information

Additional Information:

research website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Louis Michel WongKeeSong )
Study ID Numbers:	2261-05
Study First Received:	December 21, 2007
Last Updated:	September 14, 2009
ClinicalTrials.gov Identifier:	NCT00587405 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Watermelon Stomach
Cryotherapy
Argon Plasma Coagulation

Additional relevant MeSH terms:

Digestive System Diseases
Stomach Diseases
Gastrointestinal Diseases
Angiodysplasia

Vascular Diseases
Cardiovascular Diseases
Gastric Antral Vascular Ectasia

ClinicalTrials.gov processed this record on November 22, 2009