Cyrotherapy vs. APC in GAVE

Mayo Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Watermelon Stomach

Treatments: Procedure: cryotherapy; Procedure: Argon Plasma Coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00587405

2261-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Active Comparator group

Description:

Cryotherapy

Treatment:

Procedure: cryotherapy

2

Active Comparator group

Description:

Argon Plasma Coagulation

Treatment:

Procedure: Argon Plasma Coagulation