Long-term Endoscopic Follow-up of Benign Epithelial Gastric Polyps (LEFBEGP)

May 5, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First affliated hospital of Xi'an Jiaotong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hongxia Li, M.D.
        • Sub-Investigator:
          • Shuixiang He, M.D.
        • Sub-Investigator:
          • Shuying Wang, M.D.
        • Sub-Investigator:
          • Mudan Ren, M.D.
        • Sub-Investigator:
          • Yun Feng, M.D.
        • Sub-Investigator:
          • Yan Zhao, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects of this study are 18 to 70 years old patients who underwent gastroscopy from September 10, 2020 to December 31, 2021 and were confirmed by biopsy to be benign epithelial gastric polyps patients. At the same time, there are no exclusion criteria for the research objects.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between size and pathological type of benign epithelial gastric polyp and polyp development.
Time Frame: 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.
The planned observation period of this study is 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between helicobacter pylori infection and pathological type of benign epithelial gastric polyp.
Time Frame: 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.
The planned observation period of this study is 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Hongxia Li, M.D., First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Anticipated)

September 10, 2023

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2018-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We plan to share individual participant data with relevant industry researchers.

IPD Sharing Time Frame

The data will be open and shared by December 2022 for three years.

IPD Sharing Access Criteria

Registered and certified medical researchers.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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