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

NCT ID: NCT04522752

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2023-09-10

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 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.

Conditions

Benign Gastric Polyp

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Gastric Polyp

The included subjects were patients with benign epithelial gastric polyps confirmed by gastroscopy and biopsy pathology. The size and pathology type of polyps were identified. Gastroscopy and biopsy were followed up six, twelve and eighteen months later to observe the relationship between the size, pathology types of polyps and the development of gastric polyps. Other factors including the relationship between helicobacter pylori infection and polyp type were also observed.

Size and pathological type of benign epithelial gastric polyp

Intervention Type: OTHER

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.

Interventions

Size 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongxia Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongxia Li, M.D.

Role: CONTACT

hongxia1105@126.com

0086-029-85323920

Yun Feng, M.D.

Role: CONTACT

fengyun891120@163.com

0086-029-85323920

Facility Contacts

Hongxia Li, M.D.

Role: primary

hongxia1105@126.com

0086-029-85323920

Yun Feng, M.D.

Role: backup

fengyun891120@163.com

0086-029-85323920

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

XJTU1AF-CRF-2018-016

Identifier Type: -

Identifier Source: org_study_id