Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2024

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.

Interventions

  • Procedure: Hybrid Argon Plasma Coagulation
    • Argon Plasma Coagulation after water injection for local ablation

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • Complete ablation of gastric low grade intraepithelial neoplasia
    • Time Frame: 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 Measures

  • Operative time
    • Time Frame: 1 day
    • Time to complete the procedure
  • Intraoperative bleeding
    • Time Frame: 1 day
    • 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
  • Pain after procedure
    • Time Frame: 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
  • Development of new neoplasia
    • Time Frame: 12, 24 and 36 months
    • Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers
  • Progression of Low grade intraepithelial neoplasia
    • Time Frame: 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
    • Time Frame: 7 days
    • Development of postoperative complications including bleeding and perforation
  • Number of HybridAPC procedures required for treatment
    • Time Frame: 12 months
    • The number of Hybrid Argon Plasma Coagulation performed for complete ablation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Collaborator
    • Nanfang Hospital, Southern Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Philip Wai Yan CHIU, Professor – Chinese University of Hong Kong
  • Overall Official(s)
    • Philip WY Chiu, MD, Principal Investigator, Chinese University of Hong Kong
  • Overall Contact(s)
    • Philip WU Chiu, MD, +85235053952, philipchiu@surgery.cuhk.edu.hk

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