Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)

Inclusion criteria

• Diagnosis of antral-predominant GAVE: Endoscopic confirmation of gastric-antral vascular ectasia affecting the antrum, without severe portal-hypertensive gastropathy. Sub-classify as nodular or non-nodular GAVE.

• Age: ≥ 18 years at the time of consent.
• Recent transfusion-dependent anemia

• ≥ 1 packed-RBC transfusion for GAVE-related bleeding within the last 6 months to maintain hemoglobin (Hgb) > 8 g/dL (or > 7 g/dL if no coronary/vascular disease).
• Standard-of-care transfusion thresholds:

• If no coronary artery/vascular disease (CVD): transfuse 2 units when Hgb < 7 g/dL.
• If CVD present: transfuse 2 units when Hgb < 8 g/dL.
• After any transfusion, re-check Hgb within 1 week and repeat transfusion per the same criteria as needed.
• Documented transfusion history:

o Medical records must show indication that each transfusion was for presumed GAVE-related bleeding.

• Treatment status:

o Either treatment-naïve or ≤ 3 prior endoscopic ablation sessions for GAVE.

• Baseline data availability: Participant records must include endoscopic treatment dates, hemoglobin values, and transfusion data for 6 months prior to enrollment (extension up to 9 months permitted if data unavailable). Required elements:

• total number of transfusions,
• total number of prior endoscopic treatments, and calculated change in hemoglobin from baseline: Δ Hgb = Hgb(T-6 mo) - Hgb(T0) [extendable to Hgb(T-9 mo) if 6-month data are incomplete]
• Capacity to consent: Able and willing to provide written informed consent.

Exclusion criteria

• Other gastrointestinal pathology

o Active peptic-ulcer disease, inflammatory bowel disease, severe portal-hypertensive gastropathy, or untreated esophageal/gastric varices.

• Coagulopathy

o Known bleeding disorder or acquired coagulopathy not attributable to GAVE.

• Severe comorbidity / high procedural risk

• Advanced heart failure, severe renal impairment, or any condition classified ASA IV or V.
• Estimated life-expectancy < 6 months.
• Karnofsky performance status ≤ 40.
• Deemed unfit for endoscopic procedures by the treating physician.
• Pregnancy / lactation:

o Pregnant or breastfeeding, or planning pregnancy within 6 months of consent.

• Prior incompatible therapy

o Previous cryoballoon ablation for GAVE.

• Ability to participate

• Unable or unwilling to comply with the protocol or follow-up schedule.
• Unable or unwilling to provide written informed consent.