Gastric Low Grade Intraepithelial NeoplasiaHybridAPCNCT04197180
Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia
A study testing Hybrid Argon Plasma Coagulation in people with Gastric Low Grade Intraepithelial Neoplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Low Grade Intraepithelial Neoplasia
- What is being tested?
- Hybrid Argon Plasma Coagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, 00000
Philip Chiu, MD, 85226322627, philipchiu@surgery.cuhk.edu.hk
Man Yee Yung, +85235052956, myyung@surgery.cuhk.edu.hk
About this study
Official title: 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.
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.
- Being tested
- Hybrid Argon Plasma Coagulation
- Keywords
- Gastric low grade intraepithelial neoplasia, Hybrid APC, Endoscopic Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Argon Plasma CoagulationProcedure or surgery
Argon Plasma Coagulation after water injection for local ablation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Hybrid Argon Plasma Coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
Operative time
Time to complete the procedure
Measured: 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
Measured: 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
Measured: 3 days
Development of new neoplasia
Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers
Measured: 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
Measured: 12, 24 and 36 months
Postoperative complications
Development of postoperative complications including bleeding and perforation
Measured: 7 days
Number of HybridAPC procedures required for treatment
The number of Hybrid Argon Plasma Coagulation performed for complete ablation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start1 Mar 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Low Grade Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Shenzhen Hospital of Southern Medical University, The Fifth Affiliated Hospital of Zunyi Medical College
- Responsible party
- Principal investigator, Philip Wai Yan CHIU, Chinese University of Hong Kong
- Investigators
- Philip WY Chiu, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197180
- Sponsor's protocol ID
- CREC 2019.490-T
- Acronym
- HybridAPC
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HybridAPC for the Treatment of Gastric Low Grade Intraepithelial Neoplasia (LGIN): a Prospective, Multi-center Study
- ClinicalTrials.gov ID
- NCT04197180
- Acronym / sponsor ID
- HybridAPC / CREC 2019.490-T
- Keywords
- Gastric low grade intraepithelial neoplasia, Hybrid APC, Endoscopic Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Shenzhen Hospital of Southern Medical University, The Fifth Affiliated Hospital of Zunyi Medical College
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid Argon Plasma Coagulation | Experimental | Procedure: Hybrid Argon Plasma CoagulationThe 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Argon Plasma CoagulationArgon Plasma Coagulation after water injection for local ablation | Procedure or surgery | Hybrid Argon Plasma Coagulation |
Primary outcome
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.
7 secondary outcomes
Operative time
Time frame: 1 day
Intraoperative bleeding
Time frame: 1 day
Pain after procedure
Time frame: 3 days
Development of new neoplasia
Time frame: 12, 24 and 36 months
Progression of Low grade intraepithelial neoplasia
Time frame: 12, 24 and 36 months
Postoperative complications
Time frame: 7 days
Number of HybridAPC procedures required for treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric Low Grade Intraepithelial Neoplasia
Not yet recruitingObservational study
Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD
Gastric Cancer (Diagnosis), Gastric High-grade Intraepithelial Neoplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip WY Chiu, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Argon Plasma Coagulation in people with Gastric Low Grade Intraepithelial Neoplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip WU Chiu, MD (+85235053952, philipchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ablation of gastric low grade intraepithelial neoplasia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.