Gastric Low Grade Intraepithelial Neoplasia
Conditions
Keywords
Gastric low grade intraepithelial neoplasia, Hybrid APC, Endoscopic Ablation
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.
Interventions
PROCEDUREHybrid Argon Plasma Coagulation
Argon Plasma Coagulation after water injection for local ablation
Sponsors
Nanfang Hospital, Southern Medical University
Shenzhen Hospital of Southern Medical University
The Fifth Affiliated Hospital of Zunyi Medical College
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete ablation of gastric low grade intraepithelial neoplasia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | 1 day | Time to complete the procedure |
| Intraoperative bleeding | 1 day | 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 |
| Development of new neoplasia | 12, 24 and 36 months | Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers |
| Pain after procedure | 3 days | 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 |
| Postoperative complications | 7 days | Development of postoperative complications including bleeding and perforation |
| Number of HybridAPC procedures required for treatment | 12 months | The number of Hybrid Argon Plasma Coagulation performed for complete ablation |
| Progression of Low grade intraepithelial neoplasia | 12, 24 and 36 months | Progression of the development of low grade intraepithelial neoplasia to high grade intraepithelial neoplasia or advanced gastric cancer |
Countries
Hong Kong
Contacts
Primary ContactPhilip WU Chiu, MD
Backup ContactHon Chi Yip, MBChB
Outcome results
None listed