Cyrotherapy vs. APC in GAVE

NCT00587405 | Completed Phase 2

• 1 other identifier: 2261-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Watermelon Stomach

Keywords

Watermelon Stomach; Cryotherapy; Argon Plasma Coagulation

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• Endoscopic response will constitute the secondary outcome

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Cryotherapy

Procedure: cryotherapy

2

ACTIVE COMPARATOR

Argon Plasma Coagulation

Procedure: Argon Plasma Coagulation

Interventions

cryotherapy PROCEDURE

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.

1

Argon Plasma Coagulation PROCEDURE

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

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo CLinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Interventions

Cryotherapy; Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Electrocoagulation; Cautery; Hemostatic Techniques; Ablation Techniques; Surgical Procedures, Operative; Hemostasis, Surgical

Study Officials

• Louis M Wongkeesong, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 7, 2016

Record last verified: 2010-04

Locations

US (1)