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| Name | Class |
|---|---|
| Nanfang Hospital, Southern Medical University | OTHER |
| Shenzhen Hospital of Southern Medical University | OTHER |
| The Fifth Affiliated Hospital of Zunyi Medical College | OTHER |
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This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Argon Plasma Coagulation | Procedure | Argon Plasma Coagulation after water injection for local ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Time to complete the procedure | 1 day |
| Intraoperative bleeding | Bleeding during the procedure as defined by Grade Definition 0 No bleeding
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip WU Chiu, MD | Contact | +85235053952 | philipchiu@surgery.cuhk.edu.hk | |
| Hon Chi Yip, MBChB | Contact | +85235052956 | hcyip@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Philip WY Chiu, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Endoscopy Center, Prince of Wales Hospital | Recruiting | Hong Kong | 00000 | Hong Kong |
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| 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 | 3 days |
| Development of new neoplasia | Development of new neoplasia including low grade intraepithelial neoplasia, high grade intraepithelial neoplasia and advanced gastric cancers | 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 | 12, 24 and 36 months |
| Postoperative complications | Development of postoperative complications including bleeding and perforation | 7 days |
| Number of HybridAPC procedures required for treatment | The number of Hybrid Argon Plasma Coagulation performed for complete ablation | 12 months |