Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

NCT ID: NCT04197180

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Gastric Low Grade Intraepithelial Neoplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Hybrid Argon Plasma Coagulation

Intervention Type: PROCEDURE

Argon Plasma Coagulation after water injection for local ablation

Interventions

Hybrid Argon Plasma Coagulation

Argon Plasma Coagulation after water injection for local ablation

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role: collaborator

The Fifth Affiliated Hospital of Zunyi Medical College

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Philip Wai Yan CHIU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip WY Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Philip WU Chiu, MD

Role: CONTACT

philipchiu@surgery.cuhk.edu.hk

+85235053952

Hon Chi Yip, MBChB

Role: CONTACT

hcyip@surgery.cuhk.edu.hk

+85235052956

Facility Contacts

Philip Chiu, MD

Role: primary

philipchiu@surgery.cuhk.edu.hk

85226322627

Man Yee Yung

Role: backup

myyung@surgery.cuhk.edu.hk

+85235052956

Other Identifiers

CREC 2019.490-T

Identifier Type: -

Identifier Source: org_study_id