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Long-term Endoscopic Follow-up of Benign Epithelial Gastric Polyps

Long-term Endoscopic Follow-up of Benign Epithelial Gastric Polyps: a Multicenter Prospective Large Sample Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04522752
Acronym
LEFBEGP
Enrollment
200
Registered
2020-08-21
Start date
2020-09-30
Completion date
2023-09-10
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Gastric Polyp

Keywords

benign gastric polyp, gastroendoscopy, pathological type

Brief summary

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 aone size fits allmode 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.

Interventions

OTHERSize and pathological type of benign epithelial gastric polyp

All subjects will undergo gastroscopy and biopsy to determine the size and pathological type of benign epithelial gastric polyps.The correlation between polyp size and type and polyp development was observed at 6 months, 12 months and 18 months after inclusion.

Sponsors

First Affiliated Hospital Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between size and pathological type of benign epithelial gastric polyp and polyp development.The planned observation period of this study is 18 months.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.

Secondary

MeasureTime frameDescription
Correlation between helicobacter pylori infection and pathological type of benign epithelial gastric polyp.The planned observation period of this study is 18 months.To investigate the infection status of the subjects with Helicobacter pylori and analyze its correlation with the pathological types of benign epithelial gastric polyps.

Countries

China

Contacts

Primary ContactHongxia Li, M.D.
hongxia1105@126.com0086-029-85323920
Backup ContactYun Feng, M.D.
fengyun891120@163.com0086-029-85323920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026