Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

N/AUnknownNCT04197180

Chinese University of Hong Kong100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Gastric Low Grade Intraepithelial Neoplasia

Interventions

Hybrid Argon Plasma CoagulationPROCEDURE

Argon Plasma Coagulation after water injection for local ablation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Operative time

Time to complete the procedure

Time frame: 1 day

Intraoperative bleeding

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

Time frame: 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

Time frame: 3 days

Development of new neoplasia

Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers

Time frame: 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

Time frame: 12, 24 and 36 months

Postoperative complications

Development of postoperative complications including bleeding and perforation

Central Contacts

Philip WU Chiu, MD

CONTACT

+85235053952 philipchiu@surgery.cuhk.edu.hk

Hon Chi Yip, MBChB

CONTACT

+85235052956 hcyip@surgery.cuhk.edu.hk

Data from ClinicalTrials.gov

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