Helicobacter Pylori Infection Clinical Trial
Official title:
High-Definition White Light Endoscopy vs Optical Enhancement With High Definition Optical Magnification in the Diagnosis of Gastritis, H. Pylori Infection and Atrophic Gastritis in Dyspeptic Patients: A Randomized Controlled Trial.
Verified date | February 2021 |
Source | Instituto Ecuatoriano de Enfermedades Digestivas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Gastric cancer is the third most common cause of cancer-related death worldwide (1). Upper endoscopy is necessary to detect neoplastic macroscopic features at an early stage, but subtle abnormalities in the gastric mucosa are often missed or misdiagnosed (1). Helicobacter pylori (Hp) is involved in the pathogenesis of gastric diseases, such as, peptic ulcers, gastric lymphoma, and gastric cancer. Therefore, the necessity to recognize malignant gastric lesions at an early stage is imperative.
Status | Completed |
Enrollment | 150 |
Est. completion date | November 15, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - above 18 years of age - agreed to participate in the study - patients with dyspepsia in accordance with Rome criteria Exclusion Criteria: - those taking NSAIDS, PPIs or antibiotics three weeks prior invitation - severe uncontrolled coagulopathy - prior history of gastric surgery - those pregnant or nursing females |
Country | Name | City | State |
---|---|---|---|
Ecuador | Ecuadorian Institute of Digestive Diseases | Guayaquil | Guayas |
Lead Sponsor | Collaborator |
---|---|
Instituto Ecuatoriano de Enfermedades Digestivas |
Ecuador,
Hussain I, Ang TL. Evidence based review of the impact of image enhanced endoscopy in the diagnosis of gastric disorders. World J Gastrointest Endosc. 2016 Dec 16;8(20):741-755. doi: 10.4253/wjge.v8.i20.741. Review. — View Citation
Robles-Medranda C, Valero M, Puga-Tejada M, Oleas R, Baquerizo-Burgos J, Soria-Alcívar M, Alvarado-Escobar H, Pitanga-Lukashok H. High-definition optical magnification with digital chromoendoscopy detects gastric mucosal changes in dyspeptic-patients. World J Gastrointest Endosc. 2020 Jan 16;12(1):23-32. doi: 10.4253/wjge.v12.i1.23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1. Overall accuracy of High-definition white light endoscopy to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia. | histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia. | 3-month after index endoscopy | |
Primary | 2. Overall accuracy of optical enhancement with optical magnification to detect lesions compatible with gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia. | histological analysis of gastritis, H. pylori infection, gastric atrophy or intestinal metaplasia. | 3-month after index endoscopy | |
Primary | 3. Comparative analysis between High-definition white light endoscopy and optical enhancement with optical magnification with histological analysis. | statistical analysis of the accuracy for both diagnostic methods | 1-month after finishing enrollment |
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