Benign Gastric Polyp Clinical Trial
— LEFBEGPOfficial title:
Long-term Endoscopic Follow-up of Benign Epithelial Gastric Polyps: a Multicenter Prospective Large Sample Cohort Study
Benign epithelial gastric polyps are benign raised lesions that originate from the gastric mucosa or submucosa and protrude from the gastric cavity with a wide base or a pedicle.The diagnosis and treatment of benign epithelial gastric polyps are currently controversial. There is still a lack of clinical research evidence especially for the malignant tendency and related treatments of gastric polyps. Many doctors have ambiguous understanding of benign epithelial gastric polyps and their endoscopic management is still in a"one size fits all"mode in China, which greatly wastes medical resources and increases the medical risks of patients, So it is imminent to formulate management practices for the diagnosis and treatment of gastric polyps. Therefore, a full understanding of the clinical characteristics, endoscopic characteristics and long-term follow-up trends of benign epithelial gastric polyps is of great significance for clinicians to formulate reasonable treatment and follow-up plans. This study is a prospective, large-sample observational cohort study. It is planned to include 200 patients with biopsy confirmed benign epithelial gastric polyps participating in this study from September 10, 2020 to December 31, 2021 and followed up for 18 months. The main research endpoint is the correlation between size and pathological type of benign epithelial gastric polyps and polyps development. The secondary research endpoint is the correlation between type of benign epithelial gastric polyps and Helicobacter pylori infection. The research results will help provide long-term follow-up data for benign epithelial gastric polyps of different pathological types, thereby providing first-hand evidence-based medical data for formulating gastric polyp management guidelines, helping to efficiently screen high-risk groups and guiding their examination, treatment and long-term follow-up to achieve early detection and early treatment of gastric cancer, thereby reducing the mortality rate.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | September 10, 2023 |
| Est. primary completion date | September 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - After gastroscopy, gastric polyps are found and pathological biopsy is obtained. All polyps undergo endoscopic clamp biopsy, requiring at least one piece of tissue from each polyp to be submitted for examination. Exclusion Criteria: - Submucosal raised lesions. - Gastrointestinal bleeding. - Concomitant with gastric malignant tumor disease or previous gastric surgery for any reason. - Benign polyps with a diameter greater than 1cm, regardless of the pathological type. - The patient also has other serious diseases that affect the evaluation of this study, such as severe liver disease, heart disease, kidney disease, malignant tumors and alcoholism. - The patient cannot express his main complaint correctly, such as mental illness, severe neurosis, and cannot cooperate with the trial. |
| Country | Name | City | State |
|---|---|---|---|
| China | First Affliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University |
China,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation between size and pathological type of benign epithelial gastric polyp and polyp development. | Gastroscopy and pathological examination were performed at 6, 12, and 18 months after inclusion to observe the correlation between size and pathological type of benign epithelial gastric polyps and polyp development. | The planned observation period of this study is 18 months. | |
| Secondary | Correlation between helicobacter pylori infection and pathological type of benign epithelial gastric polyp. | To investigate the infection status of the subjects with Helicobacter pylori and analyze its correlation with the pathological types of benign epithelial gastric polyps. | The planned observation period of this study is 18 months. |