Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

Not Applicable

Recruiting

• Conditions: Gastric Low Grade Intraepithelial Neoplasia
• Interventions: Procedure: Hybrid Argon Plasma Coagulation

• Registration Number: NCT04197180
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Study Start: 2020-03-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hybrid Argon Plasma Coagulation	Hybrid Argon Plasma Coagulation	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

Primary Outcome Measures

Name	Time	Method
Complete ablation of gastric low grade intraepithelial neoplasia	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Operative time	1 day	Time to complete the procedure
Intraoperative bleeding	1 day	Bleeding during the procedure as defined by Grade Definition 0 No bleeding; 1. Less bleeding, could be auto-stopped or used by HibridAPC; 2. Stop bleeding by using hot forceps; 3. Stop bleeding by using clips
Development of new neoplasia	12, 24 and 36 months	Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers
Number of HybridAPC procedures required for treatment	12 months	The number of Hybrid Argon Plasma Coagulation performed for complete ablation
Pain after procedure	3 days	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
Progression of Low grade intraepithelial neoplasia	12, 24 and 36 months	Progression of the development of low grade intraepithelial neoplasia to high grade intraepithelial neoplasia or advanced gastric cancer
Postoperative complications	7 days	Development of postoperative complications including bleeding and perforation

Trial Locations

Locations (1)

Combined Endoscopy Center, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong