Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia (HybridAPC)

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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Low Grade Intraepithelial Neoplasia
• Intervention / Treatment: Procedure: Hybrid Argon Plasma Coagulation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip WU Chiu, MD; Phone Number: +85235053952; Email: philipchiu@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Hon Chi Yip, MBChB; Phone Number: +85235052956; Email: hcyip@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Recruiting
    • Combined Endoscopy Center, Prince of Wales Hospital
    • Contact: Man Yee Yung; Phone Number: +85235052956; Email: myyung@surgery.cuhk.edu.hk
    • Contact: Philip Chiu, MD; Phone Number: 85226322627; Email: philipchiu@surgery.cuhk.edu.hk
    • Principal Investigator: Philip WY Chiu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Procedure: Hybrid Argon Plasma Coagulation; Argon Plasma Coagulation after water injection for local ablation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Shenzhen Hospital of Southern Medical University; The Fifth Affiliated Hospital of Zunyi Medical College; Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Philip WY Chiu, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Gastric low grade intraepithelial neoplasia; Hybrid APC; Endoscopic Ablation
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ
• Other Study ID Numbers: CREC 2019.490-T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No