Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia (HybridAPC)

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Gastric Low Grade Intraepithelial Neoplasia

Treatments: Procedure: Hybrid Argon Plasma Coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04197180

CREC 2019.490-T

Details and patient eligibility

About

This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia.

Full description

This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia. Successful ablation is defined as no evidence of local recurrence at 12 months after HybridAPC upon follow up endoscopy. This is defined as absence of LGIN, HGIN and cancer in biopsies obtained at all locations during followup endoscopy.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Low grade intraepithelial neoplasia of stomach with size≤20 mm
2. Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN
3. Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc
4. Patients with informed consent

Exclusion criteria

1. Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.
2. Endoscopic evidence of ulcer
3. Biopsy confirmed HGIN
4. Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN
5. Pregnancy
6. informed consent not available

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Hybrid Argon Plasma Coagulation

Experimental group

Description:

The Hybrid-Argon Plasma Coagulation probe combines waterjet technology with Argon Plasma Coagulation. The probe comprises a central water channel for the submucosa injection function and a peripheral gas channel for the Argon Plasma Coagulation function

Treatment:

Procedure: Hybrid Argon Plasma Coagulation