Observational Study of Helicobacter pylori Infection and Gastric Cancer Features to Predict Cancer Behavior and Outcomes After Endoscopic Submucosal Dissection

What this Trial Is About

Researchers are evaluating the relationship between Helicobacter pylori H. pylori infection status, its distribution in the stomach, and pathological features with the biological behavior and long-term prognosis of early gastric cancer or related gastric neoplastic lesions in patients undergoing endoscopic submucosal dissection ESD. This observational study includes about 1500 participants from multiple centers, combining retrospective data from 1000 patients and prospective enrollment of 500 patients. The study addresses different H. pylori testing methods and their discordant results, aiming to clarify links between infection patterns, gastric cancer subtypes, and outcomes. Participants will not receive any experimental treatments instead, their care follows routine clinical practice including diagnostic tests like the 13C-urea breath test, serum antibody testing, pathological assessment of gastric tissue, and ESD treatment. The study groups include patients with current active H. pylori infection, persistent infection after eradication therapy, post-eradication without active infection, and those without evidence of infection. Clinical, endoscopic, pathological, and follow-up data will be collected to analyze H. pylori infection status, tissue distribution, mucosal changes, and cancer features. Participants involvement includes medical record reviews for retrospective patients and standard clinical evaluations for prospective patients. Assessments include H. pylori testing, lesion and tissue pathology, endoscopic findings, and long-term follow-up at 1, 2, and 3 years post-ESD and beyond. Outcomes measured include concordance of H. pylori tests, pathological features, recurrence rates, development of new gastric cancers, survival, and need for additional treatment. Follow-up methods involve outpatient visits, endoscopy, imaging, and telephone contact, with continuous monitoring of infection status and clinical outcomes.

Helicobacter Pylori Infection Status and Pathological Features for Predicting Gastric Cancer Biological Behavior and Prognosis: A Real-World Observational Study