Benign Gastric PolypLEFBEGPNCT04522752
Long-term Endoscopic Follow-up of Benign Epithelial Gastric Polyps
An observational study of Benign Gastric Polyp, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Benign Gastric Polyp
- What is being tested?
- Size and pathological type of benign epithelial gastric polyp
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2020to 10 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Hongxia Li, M.D., 0086-029-85323920, hongxia1105@126.com
Yun Feng, M.D., 0086-029-85323920, fengyun891120@163.com
About this study
Official 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.
- Conditions
- Benign Gastric Polyp
- Being tested
- Size and pathological type of benign epithelial gastric polyp
- Keywords
- benign gastric polyp, gastroendoscopy, pathological type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Size and pathological type of benign epithelial gastric polypOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Size and pathological type of benign epithelial gastric polyp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The planned observation period of this study is 18 months.
Secondary outcomes (1)
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.
Measured: The planned observation period of this study is 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start30 Sep 2020
- Primary completion30 Sep 2021
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Benign Gastric PolypStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongxia Li, M.D., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522752
- Sponsor's protocol ID
- XJTU1AF-CRF-2018-016
- Acronym
- LEFBEGP
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2020
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share individual participant data with relevant industry researchers.
Publications
Schmitz JM, Stolte M. Gastric polyps as precancerous lesions. Gastrointest Endosc Clin N Am. 1997 Jan;7(1):29-46.
PubMed 8995111Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.
PubMed 22198778Jalving M, Koornstra JJ, Wesseling J, Boezen HM, DE Jong S, Kleibeuker JH. Increased risk of fundic gland polyps during long-term proton pump inhibitor therapy. Aliment Pharmacol Ther. 2006 Nov 1;24(9):1341-8. doi: 10.1111/j.1365-2036.2006.03127.x.
PubMed 17059515Genta RM, Schuler CM, Robiou CI, Lash RH. No association between gastric fundic gland polyps and gastrointestinal neoplasia in a study of over 100,000 patients. Clin Gastroenterol Hepatol. 2009 Aug;7(8):849-54. doi: 10.1016/j.cgh.2009.05.015. Epub 2009 May 22.
PubMed 19465154Tran-Duy A, Spaetgens B, Hoes AW, de Wit NJ, Stehouwer CD. Use of Proton Pump Inhibitors and Risks of Fundic Gland Polyps and Gastric Cancer: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1706-1719.e5. doi: 10.1016/j.cgh.2016.05.018. Epub 2016 May 20.
PubMed 27211501Hirota WK, Zuckerman MJ, Adler DG, Davila RE, Egan J, Leighton JA, Qureshi WA, Rajan E, Fanelli R, Wheeler-Harbaugh J, Baron TH, Faigel DO; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of endoscopy in the surveillance of premalignant conditions of the upper GI tract. Gastrointest Endosc. 2006 Apr;63(4):570-80. doi: 10.1016/j.gie.2006.02.004. No abstract available.
PubMed 16564854
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Endoscopic Follow-up of Benign Epithelial Gastric Polyps: a Multicenter Prospective Large Sample Cohort Study
- ClinicalTrials.gov ID
- NCT04522752
- Acronym / sponsor ID
- LEFBEGP / XJTU1AF-CRF-2018-016
- Conditions
- Benign Gastric Polyp
- Keywords
- benign gastric polyp, gastroendoscopy, pathological type
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Polyp | – | Other: Size and pathological type of benign epithelial gastric polypThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Size and pathological type of benign epithelial gastric polypAll 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. | Other | Gastric Polyp |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Results publication: PubMed 8995111Schmitz JM, Stolte M. Gastric polyps as precancerous lesions. Gastrointest Endosc Clin N Am. 1997 Jan;7(1):29-46.
- Results publication: PubMed 22198778Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.
- Results publication: PubMed 17059515Jalving M, Koornstra JJ, Wesseling J, Boezen HM, DE Jong S, Kleibeuker JH. Increased risk of fundic gland polyps during long-term proton pump inhibitor therapy. Aliment Pharmacol Ther. 2006 Nov 1;24(9):1341-8. doi: 10.1111/j.1365-2036.2006.03127.x.
- Results publication: PubMed 19465154Genta RM, Schuler CM, Robiou CI, Lash RH. No association between gastric fundic gland polyps and gastrointestinal neoplasia in a study of over 100,000 patients. Clin Gastroenterol Hepatol. 2009 Aug;7(8):849-54. doi: 10.1016/j.cgh.2009.05.015. Epub 2009 May 22.
- Results publication: PubMed 27211501Tran-Duy A, Spaetgens B, Hoes AW, de Wit NJ, Stehouwer CD. Use of Proton Pump Inhibitors and Risks of Fundic Gland Polyps and Gastric Cancer: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2016 Dec;14(12):1706-1719.e5. doi: 10.1016/j.cgh.2016.05.018. Epub 2016 May 20.
- Results publication: PubMed 16564854Hirota WK, Zuckerman MJ, Adler DG, Davila RE, Egan J, Leighton JA, Qureshi WA, Rajan E, Fanelli R, Wheeler-Harbaugh J, Baron TH, Faigel DO; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: the role of endoscopy in the surveillance of premalignant conditions of the upper GI tract. Gastrointest Endosc. 2006 Apr;63(4):570-80. doi: 10.1016/j.gie.2006.02.004. No abstract available.
- Individual participant dataSharing planned: Yes. We plan to share individual participant data with relevant industry researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongxia Li, M.D. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Gastric Polyp, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongxia Li, M.D. (0086-029-85323920, hongxia1105@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522752, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.