NCT04197180

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

4.8 years

First QC Date

December 11, 2019

Last Update Submit

November 4, 2023

Conditions

Gastric Low Grade Intraepithelial Neoplasia

Keywords

Gastric low grade intraepithelial neoplasiaHybrid APCEndoscopic Ablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Operative time

    1 day

  • Intraoperative bleeding

    1 day

  • Pain after procedure

    3 days

  • Development of new neoplasia

    12, 24 and 36 months

  • Progression of Low grade intraepithelial neoplasia

    12, 24 and 36 months

  • +2 more secondary outcomes

Study Arms (1)

Hybrid Argon Plasma Coagulation

EXPERIMENTAL

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

Interventions

Hybrid Argon Plasma CoagulationPROCEDURE

Argon Plasma Coagulation after water injection for local ablation

Hybrid Argon Plasma Coagulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low grade intraepithelial neoplasia of stomach with size≤20 mm
  • Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN
  • Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc
  • Patients with informed consent

You may not qualify if:

  • Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.
  • Endoscopic evidence of ulcer
  • Biopsy confirmed HGIN
  • Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN
  • Pregnancy
  • informed consent not available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, 00000, Hong Kong

RECRUITING

Study Officials

  • Philip WY Chiu, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip WU Chiu, MD

CONTACT

+85235053952philipchiu@surgery.cuhk.edu.hk

Hon Chi Yip, MBChB

CONTACT

+85235052956hcyip@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 12, 2019

Study Start

March 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

HK(1)