Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

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

Detailed Description
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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.

Official Title
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HybridAPC for the Treatment of Gastric Low Grade Intraepithelial Neoplasia (LGIN): a Prospective, Multi-center Study

Conditions
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Gastric Low Grade Intraepithelial Neoplasia

Intervention / Treatment
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* Procedure: Hybrid Argon Plasma Coagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low grade intraepithelial neoplasia of stomach with size≤20 mm Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc Patients with informed consent Exclusion Criteria: Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma. Endoscopic evidence of ulcer Biopsy confirmed HGIN Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN Pregnancy informed consent not available

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Argon Plasma Coagulation<br>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 | Procedure: Hybrid Argon Plasma Coagulation<br>* Argon Plasma Coagulation after water injection for local ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete ablation of gastric low grade intraepithelial 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Time to complete the procedure | 1 day | 
| Intraoperative bleeding | Bleeding during the procedure as defined by Grade Definition 0 No bleeding Less bleeding, could be auto-stopped or used by HibridAPC Stop bleeding by using hot forceps Stop bleeding by using clips | 1 day | 
| Pain after procedure | Pain after the procedure as defined by pain score Grade Definition 0 No pain, I Slight pain, II Moderate pain, III Severe pain, IV Extreme pain. V Unbearable pain | 3 days | 
| Development of new neoplasia | Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers | 12, 24 and 36 months | 
| Progression of Low grade intraepithelial neoplasia | Progression of the development of low grade intraepithelial neoplasia to high grade intraepithelial neoplasia or advanced gastric cancer | 12, 24 and 36 months | 
| Postoperative complications | Development of postoperative complications including bleeding and perforation | 7 days | 
| Number of HybridAPC procedures required for treatment | The number of Hybrid Argon Plasma Coagulation performed for complete ablation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric low grade intraepithelial neoplasia, Hybrid APC, Endoscopic Ablation