Gastric PolypsRAGIPNCT07314554
Recurrence After Gastric and Intestinal Polyp Resection
An observational study of Gastric Polyps and Intestinal Polyps, run by LanZhou University at 1 site in China.
Trial summary
This is a retrospective and prospective cohort study designed to evaluate the recurrence rate and identify risk factors after endoscopic resection of gastric and intestinal polyps. BACKGROUND: Gastric and intestinal polyps are common digestive diseases with potential for malignant transformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Polyps, Intestinal Polyps, Colon Polyps
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2026to 25 Feb 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients (≥18 years) who underwent complete endoscopic resection of gastric or intestinal polyps at our tertiary referral center. This includes two cohorts: (1) Retrospective cohort: patients treated from 2021-2022 with existing follow-up data; (2) Prospective cohort: newly enrolled patients from 2024-2025. Eligible participants must have pathologically confirmed polyps (adenomatous, hyperplastic, inflammatory, fundic gland, serrated, or hamartomatous) with negative resection margins. The population represents a diverse group with varying polyp characteristics (size range: <5mm to >20mm; single or multiple polyps; gastric or colorectal locations) and different resection methods (EMR, ESD, snare polypectomy). Excluded are patients with hereditary polyposis syndromes, inflammatory bowel disease, prior gastrointestinal malignancy, or cancer detected at initial resection.
Who may be able to join
- Age 18 years or older
- First-time endoscopic examination (gastroscopy or colonoscopy) at the study center
- Pathologically confirmed polyp of any type (adenomatous, hyperplastic, inflammatory, fundic gland polyp, hamartomatous, serrated lesion)
- Complete endoscopic resection performed (including EMR, ESD, snare polypectomy, hot biopsy forceps, or argon plasma coagulation)
- Negative resection margins or complete resection assessed by pathology
- At least one follow-up endoscopic examination completed (for retrospective cohort) or willingness to complete follow-up (for prospective cohort)
- Complete baseline clinical data available
Who cannot join
- Hereditary polyposis syndromes (familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, juvenile polyposis syndrome)
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- Previous history of gastric or colorectal cancer
- Cancer detected at initial resection (stage T1b or higher)
- Non-polyp pathology (e.g., submucosal tumors, normal mucosa)
- Incomplete resection with positive margins that were not re-treated
Show all 9Show fewer
- Lost to follow-up with no available surveillance data (for retrospective cohort)
- Pregnancy at time of enrollment
- Inability or unwillingness to provide informed consent (for prospective cohort)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
15009460497, tianqq2023@lzu.edu.cn
About this study
Official title: Recurrence Rate and Risk Factors After Endoscopic Resection of Gastric and Intestinal Polyps: A Retrospective and Prospective Cohort Study
This is a retrospective and prospective cohort study designed to evaluate the recurrence rate and identify risk factors after endoscopic resection of gastric and intestinal polyps.
BACKGROUND: Gastric and intestinal polyps are common digestive diseases with potential for malignant transformation. Although endoscopic resection is the standard treatment, recurrence rates range from 10-50%, and the mechanisms and risk factors remain unclear.
Read more
OBJECTIVES:
Primary: To assess short-term (1-year) and long-term (3-year) recurrence rates after endoscopic polyp resection Secondary: To identify independent risk factors and develop a recurrence risk prediction model
DESIGN: Mixed retrospective-prospective cohort study
- Retrospective cohort: Patients who underwent polyp resection from 2021-2022, with follow-up data through 2024
- Prospective cohort: Patients enrolled from 2024-2025, with standardized follow-up through 2028
SETTING: Single tertiary referral center with >10,000 endoscopic polyp resections performed since 2021
PARTICIPANTS: Approximately 1,600-1,800 adult patients (≥18 years) who underwent complete endoscopic resection of gastric or intestinal polyps
FOLLOW-UP:
- Short-term: 1 year post-resection (±2 months)
- Long-term: 3 years post-resection (±3 months)
MAIN OUTCOME: Recurrence rate defined as new polyp detection at original or different sites during endoscopic surveillance
POTENTIAL RISK FACTORS: Patient demographics, polyp characteristics (size, number, location, pathology), resection method, Helicobacter pylori status, lifestyle factors, and medication use
EXPECTED IMPACT: Results will inform personalized surveillance strategies and optimize resource allocation for post-polypectomy follow-up.
- Conditions
- Gastric Polyps, Intestinal Polyps, Colon Polyps, Colorectal Polyps, Adenomatous Polyps, Gastric Adenoma and Early Gastric Cancer
- Keywords
- Polyp recurrence, Endoscopic resection, Polypectomy, Endoscopic mucosal resection, Endoscopic submucosal dissection, Risk factors, Surveillance, Follow-up, Adenoma, Gastric polyp, Colorectal polyp
- Medical subject headings
- Polyposis, Gastric, Intestinal Polyps, Colonic Polyps, Adenomatous Polyps, Stomach Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Patients who underwent endoscopic polyp resection from January 2021 to December 2022, with retrospective data collection and follow-up through December 2025 | |
| Prospective Cohort | Patients undergoing endoscopic polyp resection from October 2024 to December 2025, with prospective standardized data collection and follow-up through December 2028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Recurrence Rate at 1 Year
New polyp(s) detected by endoscopy and confirmed by pathology at 1-year follow-up. Includes both local recurrence (within 2cm of resection site) and metachronous polyps (>2cm from original site).
Measured: 1 year post-resection (10-14 months acceptable)
Long-term Recurrence Rate at 3 Years
New polyp(s) detected by endoscopy and confirmed by pathology at 3-year follow-up. Includes both local recurrence and metachronous polyps.
Measured: 3 years post-resection (33-39 months acceptable)
Cumulative Recurrence Rate
Overall recurrence rate combining 1-year and 3-year surveillance results
Measured: Up to 3 years post-resection
Secondary outcomes (5)
Recurrence-free Survival Time
Measured in months; censored at last follow-up for non-recurrent cases
Measured: Up to 3 years
Characteristics of Recurrent Polyps
Descriptive analysis of recurrent polyp features: Number, size, location, and pathological type of recurrent polyps.
Measured: At 1-year and 3-year follow-up
Progression to High-grade Dysplasia or Cancer
Pathologically confirmed progression: Proportion of participants developing high-grade dysplasia or invasive cancer during follow-up.
Measured: Up to 3 years
Re-treatment Rate
Proportion of participants requiring repeat endoscopic or surgical treatment: Includes repeat polypectomy, endoscopic resection, or surgical resection
Measured: Up to 3 years
Identification of Independent Risk Factors
Hazard ratios (HR) and 95% confidence intervals for each significant risk factor
Measured: Analysis conducted after all follow-up completed (2029)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start26 Jul 2026 (estimated)
- Primary completion25 Feb 2027 (estimated)
- Study completion25 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric PolypsStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaofeng Chen, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314554
- Sponsor's protocol ID
- LDYYczf2025121801
- Acronym
- RAGIP
- Status last verified
- Jun 2026
- First submitted
- 18 Dec 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sekiguchi M, Kakugawa Y, Matsumoto M, Matsuda T. A scoring model for predicting advanced colorectal neoplasia in a screened population of asymptomatic Japanese individuals. J Gastroenterol. 2018 Oct;53(10):1109-1119. doi: 10.1007/s00535-018-1433-7. Epub 2018 Jan 22.
PubMed 29359244Brenner H, Chang-Claude J, Jansen L, Knebel P, Stock C, Hoffmeister M. Reduced risk of colorectal cancer up to 10 years after screening, surveillance, or diagnostic colonoscopy. Gastroenterology. 2014 Mar;146(3):709-17. doi: 10.1053/j.gastro.2013.09.001. Epub 2013 Sep 5.
PubMed 24012982Click B, Pinsky PF, Hickey T, Doroudi M, Schoen RE. Association of Colonoscopy Adenoma Findings With Long-term Colorectal Cancer Incidence. JAMA. 2018 May 15;319(19):2021-2031. doi: 10.1001/jama.2018.5809.
PubMed 29800214Martinez ME, Baron JA, Lieberman DA, Schatzkin A, Lanza E, Winawer SJ, Zauber AG, Jiang R, Ahnen DJ, Bond JH, Church TR, Robertson DJ, Smith-Warner SA, Jacobs ET, Alberts DS, Greenberg ER. A pooled analysis of advanced colorectal neoplasia diagnoses after colonoscopic polypectomy. Gastroenterology. 2009 Mar;136(3):832-41. doi: 10.1053/j.gastro.2008.12.007. Epub 2008 Dec 9.
PubMed 19171141
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Rate and Risk Factors After Endoscopic Resection of Gastric and Intestinal Polyps: A Retrospective and Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07314554
- Acronym / sponsor ID
- RAGIP / LDYYczf2025121801
- Conditions
- Gastric Polyps, Intestinal Polyps, Colon Polyps, Colorectal Polyps, Adenomatous Polyps, Gastric Adenoma and Early Gastric Cancer
- Keywords
- Polyp recurrence, Endoscopic resection, Polypectomy, Endoscopic mucosal resection, Endoscopic submucosal dissection, Risk factors, Surveillance, Follow-up
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 26 Jul 2026 (estimated)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 25 Feb 2029 (estimated)
- First posted
- 2 Jan 2026 (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.
This is a retrospective and prospective cohort study designed to evaluate the recurrence rate and identify risk factors after endoscopic resection of gastric and intestinal polyps.
BACKGROUND: Gastric and intestinal polyps are common digestive diseases with potential for malignant transformation. Although endoscopic resection is the standard treatment, recurrence rates range from 10-50%, and the mechanisms and risk factors remain unclear.
OBJECTIVES:
Primary: To assess short-term (1-year) and long-term (3-year) recurrence rates after endoscopic polyp resection Secondary: To identify independent risk factors and develop a recurrence risk prediction model
DESIGN: Mixed retrospective-prospective cohort study
- Retrospective cohort: Patients who underwent polyp resection from 2021-2022, with follow-up data through 2024
- Prospective cohort: Patients enrolled from 2024-2025, with standardized follow-up through 2028
SETTING: Single tertiary referral center with >10,000 endoscopic polyp resections performed since 2021
PARTICIPANTS: Approximately 1,600-1,800 adult patients (≥18 years) who underwent complete endoscopic resection of gastric or intestinal polyps
FOLLOW-UP:
- Short-term: 1 year post-resection (±2 months)
- Long-term: 3 years post-resection (±3 months)
MAIN OUTCOME: Recurrence rate defined as new polyp detection at original or different sites during endoscopic surveillance
POTENTIAL RISK FACTORS: Patient demographics, polyp characteristics (size, number, location, pathology), resection method, Helicobacter pylori status, lifestyle factors, and medication use
EXPECTED IMPACT: Results will inform personalized surveillance strategies and optimize resource allocation for post-polypectomy follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –Patients who underwent endoscopic polyp resection from January 2021 to December 2022, with retrospective data collection and follow-up through December 2025 |
| Prospective Cohort | – | –Patients undergoing endoscopic polyp resection from October 2024 to December 2025, with prospective standardized data collection and follow-up through December 2028 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (≥18 years) who underwent complete endoscopic resection of gastric or intestinal polyps at our tertiary referral center. This includes two cohorts: (1) Retrospective cohort: patients treated from 2021-2022 with existing follow-up data; (2) Prospective cohort: newly enrolled patients from 2024-2025. Eligible participants must have pathologically confirmed polyps (adenomatous, hyperplastic, inflammatory, fundic gland, serrated, or hamartomatous) with negative resection margins. The population represents a diverse group with varying polyp characteristics (size range: <5mm to >20mm; single or multiple polyps; gastric or colorectal locations) and different resection methods (EMR, ESD, snare polypectomy). Excluded are patients with hereditary polyposis syndromes, inflammatory bowel disease, prior gastrointestinal malignancy, or cancer detected at initial resection.
Key inclusion criteria (7 listed)
- Age 18 years or older
- First-time endoscopic examination (gastroscopy or colonoscopy) at the study center
- Pathologically confirmed polyp of any type (adenomatous, hyperplastic, inflammatory, fundic gland polyp, hamartomatous, serrated lesion)
- Complete endoscopic resection performed (including EMR, ESD, snare polypectomy, hot biopsy forceps, or argon plasma coagulation)
- Negative resection margins or complete resection assessed by pathology
Key exclusion criteria (9 listed)
- Hereditary polyposis syndromes (familial adenomatous polyposis, Lynch syndrome, Peutz-Jeghers syndrome, juvenile polyposis syndrome)
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- Previous history of gastric or colorectal cancer
- Cancer detected at initial resection (stage T1b or higher)
- Non-polyp pathology (e.g., submucosal tumors, normal mucosa)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term Recurrence Rate at 1 Year
Time frame: 1 year post-resection (10-14 months acceptable)
New polyp(s) detected by endoscopy and confirmed by pathology at 1-year follow-up. Includes both local recurrence (within 2cm of resection site) and metachronous polyps (>2cm from original site).
Long-term Recurrence Rate at 3 Years
Time frame: 3 years post-resection (33-39 months acceptable)
New polyp(s) detected by endoscopy and confirmed by pathology at 3-year follow-up. Includes both local recurrence and metachronous polyps.
Cumulative Recurrence Rate
Time frame: Up to 3 years post-resection
Overall recurrence rate combining 1-year and 3-year surveillance results
5 secondary outcomes
Recurrence-free Survival Time
Time frame: Up to 3 years
Characteristics of Recurrent Polyps
Time frame: At 1-year and 3-year follow-up
Progression to High-grade Dysplasia or Cancer
Time frame: Up to 3 years
Re-treatment Rate
Time frame: Up to 3 years
Identification of Independent Risk Factors
Time frame: Analysis conducted after all follow-up completed (2029)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 29359244Sekiguchi M, Kakugawa Y, Matsumoto M, Matsuda T. A scoring model for predicting advanced colorectal neoplasia in a screened population of asymptomatic Japanese individuals. J Gastroenterol. 2018 Oct;53(10):1109-1119. doi: 10.1007/s00535-018-1433-7. Epub 2018 Jan 22.
- Background: PubMed 24012982Brenner H, Chang-Claude J, Jansen L, Knebel P, Stock C, Hoffmeister M. Reduced risk of colorectal cancer up to 10 years after screening, surveillance, or diagnostic colonoscopy. Gastroenterology. 2014 Mar;146(3):709-17. doi: 10.1053/j.gastro.2013.09.001. Epub 2013 Sep 5.
- Background: PubMed 29800214Click B, Pinsky PF, Hickey T, Doroudi M, Schoen RE. Association of Colonoscopy Adenoma Findings With Long-term Colorectal Cancer Incidence. JAMA. 2018 May 15;319(19):2021-2031. doi: 10.1001/jama.2018.5809.
- Background: PubMed 19171141Martinez ME, Baron JA, Lieberman DA, Schatzkin A, Lanza E, Winawer SJ, Zauber AG, Jiang R, Ahnen DJ, Bond JH, Church TR, Robertson DJ, Smith-Warner SA, Jacobs ET, Alberts DS, Greenberg ER. A pooled analysis of advanced colorectal neoplasia diagnoses after colonoscopic polypectomy. Gastroenterology. 2009 Mar;136(3):832-41. doi: 10.1053/j.gastro.2008.12.007. Epub 2008 Dec 9.
- Individual participant dataSharing planned: No
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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.
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 Gastric Polyps and Intestinal Polyps, run by LanZhou 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 7 inclusion and 9 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: opening soon, as of the sponsor's last update on 9 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiangqiang Tian (86+15009460497, tianqq2023@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term Recurrence Rate at 1 Year (time frame: 1 year post-resection (10-14 months acceptable)). The study lists 3 primary outcomes in all. 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 NCT07314554, which also lists 4 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 Jun 2026.