Gastric Low Grade Intraepithelial Neoplasia Clinical Trial
— HybridAPCOfficial 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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Combined Endoscopy Center, Prince of Wales Hospital | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese University of Hong Kong | Nanfang Hospital, Southern Medical University, Shenzhen Hospital of Southern Medical University, The Fifth Affiliated Hospital of Zunyi Medical College |
Hong Kong,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Operative time | Time to complete the procedure | 1 day | |
| Secondary | 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 |
1 day | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Postoperative complications | Development of postoperative complications including bleeding and perforation | 7 days | |
| Secondary | Number of HybridAPC procedures required for treatment | The number of Hybrid Argon Plasma Coagulation performed for complete ablation | 12 months |