CClinicalTrials.gg
RecruitingNCT04197180HybridAPCUpdated Nov 7, 2023

Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

An interventional study of Hybrid Argon Plasma Coagulation in Gastric Low Grade Intraepithelial Neoplasia, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2020; still recruiting 6 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gastric Low Grade Intraepithelial Neoplasia

Keywords

  • Gastric low grade intraepithelial neoplasia
  • Hybrid APC
  • Endoscopic Ablation
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureHybrid Argon Plasma Coagulation

    Argon Plasma Coagulation after water injection for local ablation

06

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. Operative time

    Time to complete the procedure

    Time frame: 1 day

  2. 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

  3. 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

  4. 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

  5. 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

  6. Postoperative complications

    Development of postoperative complications including bleeding and perforation

    Time frame: 7 days

  7. Number of HybridAPC procedures required for treatment

    The number of Hybrid Argon Plasma Coagulation performed for complete ablation

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04197180
Lead sponsor
Chinese University of Hong Kong
Collaborators
Nanfang Hospital, Southern Medical University, Shenzhen Hospital of Southern Medical University, The Fifth Affiliated Hospital of Zunyi Medical College
Responsible party
Philip Wai Yan CHIU (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Dec 12, 2019
Start date
Mar 1, 2020
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 7, 2023

Study contacts

Philip WU Chiu, MD
Contact
philipchiu@surgery.cuhk.edu.hk
+85235053952
Hon Chi Yip, MBChB
Contact
hcyip@surgery.cuhk.edu.hk
+85235052956
Philip WY Chiu, MD
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion