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Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia (HybridAPC)

Primary Purpose

Gastric Low Grade Intraepithelial Neoplasia

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Hybrid Argon Plasma Coagulation
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Low Grade Intraepithelial Neoplasia focused on measuring Gastric low grade intraepithelial neoplasia, Hybrid APC, Endoscopic Ablation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Combined Endoscopy Center, Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hybrid Argon Plasma Coagulation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Operative time
Time to complete the procedure
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
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
Development of new neoplasia
Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers
Progression of Low grade intraepithelial neoplasia
Progression of the development of low grade intraepithelial neoplasia to high grade intraepithelial neoplasia or advanced gastric cancer
Postoperative complications
Development of postoperative complications including bleeding and perforation
Number of HybridAPC procedures required for treatment
The number of Hybrid Argon Plasma Coagulation performed for complete ablation

Full Information

First Posted
December 11, 2019
Last Updated
May 1, 2022
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
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1. Study Identification

Unique Protocol Identification Number
NCT04197180
Brief Title
Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia
Acronym
HybridAPC
Official Title
HybridAPC for the Treatment of Gastric Low Grade Intraepithelial Neoplasia (LGIN): a Prospective, Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Low Grade Intraepithelial Neoplasia
Keywords
Gastric low grade intraepithelial neoplasia, Hybrid APC, Endoscopic Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Argon Plasma Coagulation
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Hybrid Argon Plasma Coagulation
Intervention Description
Argon Plasma Coagulation after water injection for local ablation
Primary Outcome Measure Information:
Title
Complete ablation of gastric low grade intraepithelial neoplasia
Description
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 Outcome Measure Information:
Title
Operative time
Description
Time to complete the procedure
Time Frame
1 day
Title
Intraoperative bleeding
Description
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
Time Frame
1 day
Title
Pain after procedure
Description
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
Title
Development of new neoplasia
Description
Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers
Time Frame
12, 24 and 36 months
Title
Progression of Low grade intraepithelial neoplasia
Description
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
Title
Postoperative complications
Description
Development of postoperative complications including bleeding and perforation
Time Frame
7 days
Title
Number of HybridAPC procedures required for treatment
Description
The number of Hybrid Argon Plasma Coagulation performed for complete ablation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip WU Chiu, MD
Phone
+85235053952
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Hon Chi Yip, MBChB
Phone
+85235052956
Email
hcyip@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Combined Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Chiu, MD
Phone
85226322627
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Man Yee Yung
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hybrid APC for Gastric Low Grade Intraepithelial Neoplasia

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