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Colo-rectal CancerNCT07445178

Piecemeal Resection and Advanced Histology Independently Predict Local Recurrence After Colorectal Snare-based Endoscopic Resection: a Time-to-event Cohort Study

An observational study of Colo-rectal Cancer, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this retrospective cohort observational study is to identify variables related to the recurrence of colorectal lesions after snare polypectomy resection in colonoscopies. It also aims to evaluate the safety of the procedure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colo-rectal Cancer
How many people
255 participants
Where
1 siteBrazil
Study dates
4 Dec 2025to 24 Feb 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consisted of 255 consecutive adult patients (≥18 years) who underwent loop colorectal polypectomy, with or without the use of thermal energy, at a tertiary referral center between 2023 and 2025. Only individuals with available histopathological examination of the resected lesion and who had undergone at least one documented surveillance colonoscopy, allowing evaluation of the previous resection site, were included. Patients who underwent advanced non-loop-based techniques, those without endoscopic follow-up, and cases with incomplete clinical or histological data were excluded, ensuring methodological homogeneity and adequate measurement of outcomes.

Who may be able to join

  • Age ≥ 18 years at the time of polypectomy;
  • Underwent snare polypectomy, with or without the use of thermal energy (cold snare or hot snare), performed during the study period (2023-2025);
  • Procedure performed at a participating tertiary center, ensuring technical and record standardization;
  • Availability of histopathological examination of the resected lesion, allowing for adequate histological characterization;
  • Performance of at least one documented surveillance colonoscopy, with evaluation of the previous resection site;
  • Adequate recording of clinical and endoscopic variables necessary for analysis (lesion size, location, resection technique, etc.);

Who cannot join

  • Patients undergoing techniques other than loop polypectomy, such as: Endoscopic submucosal dissection (ESD), advanced mucosal resection not based on conventional loop, primary surgical resection of the lesion;
  • Absence of follow-up colonoscopy, making it impossible to assess the primary outcome (local recurrence);
  • Incomplete clinical, endoscopic, or histopathological data that prevent adequate classification of study variables;
  • Invasive lesions beyond the mucosa (invasive cancer with deep submucosal invasion) that have been referred for immediate surgical treatment without endoscopic follow-up;
  • Loss to follow-up before the first surveillance colonoscopy.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Hospital das Clínicas of Ribeirão Preto Medical School

    Ribeirão Preto, São Paulo, 14048-900

Other trials in Brazil

About this study

The objective of this retrospective cohort observational study is to identify variables related to the recurrence of colorectal lesions after snare polypectomy resection in colonoscopies. It also aims to evaluate the safety of the procedure. The main questions to be answered are:

  • What endoscopic characteristics are most related to recurrence?
  • What adverse events are related to the procedure?

The researchers will perform a chart analysis looking for demographic, clinical, endoscopic, and histological variables in order to identify which factors are most closely linked to the recurrence of previously resected lesions.

Read the detailed description
  1. Scientific Basis Endoscopic resection represents one of the main strategies for preventing colorectal cancer, significantly reducing the incidence and mortality associated with the disease. Snare polypectomy, with or without the use of thermal energy (cold snare or hot snare), is widely used in clinical practice due to its efficacy, applicability, and favorable safety profile. However, despite the high initial success rate, local recurrence at the resection site remains a relevant clinical outcome, especially in larger lesions, piecemeal resections, and cases with advanced histological characteristics. The literature shows heterogeneity regarding independent predictors of recurrence, particularly when analyzed using time-to-event methodology. Given this scenario, it becomes essential to identify clinical, endoscopic, and histopathological variables associated with local recurrence, allowing for better risk stratification and optimization of surveillance protocols.
  2. Objectives Primary Objective: To identify variables associated with local recurrence after loop colorectal polypectomy. Secondary Objectives: To evaluate the occurrence of metachronous adenomas; To assess the safety of the procedure through the analysis of related adverse events; To determine independent predictors of recurrence using time-to-event analysis;
  3. Study Design Type: Retrospective observational cohort. Analytical model: Longitudinal study with time-to-event analysis. Center: Tertiary referral center. Inclusion period: 2023 to 2025. Sample: 255 consecutive adult patients. Essential criterion: Undergoing at least one surveillance colonoscopy after initial polypectomy.
  4. Study Population Inclusion Criteria: Patients ≥18 years; Underwent snare colorectal polypectomy (with or without thermal energy); Availability of histopathological examination; At least one documented follow-up colonoscopy; Exclusion Criteria: Resection by non-loop-based techniques (e.g., isolated ESD); Absence of endoscopic follow-up; Incomplete clinical or histological data;
  5. Characterization of the Lesions The lesions were described according to: Size: dichotomized into
  • <10 mm;
  • ≥10 mm; Location: right colon, transverse colon, left colon, or rectum. Morphological classification: according to the Paris Classification. Resection technique:
  • En bloc;
  • Piecemeal; Histopathology:
  • Tubular adenoma;
  • Tubulovillous adenoma;
  • Villous adenoma;
  • Serrated lesions;
  • Intramucosal carcinoma; * Advanced histology: defined as the presence of high-grade dysplasia and/or intramucosal adenocarcinoma.
  1. Outcomes 6.1 Primary Outcome Local recurrence, defined as endoscopic identification and histological confirmation of neoplastic tissue at the site of previous resection during surveillance colonoscopy. 6.2 Secondary Outcomes Metachronous adenoma: development of a new lesion at a site distinct from the initial resection. Adverse events related to the procedure, including:
  • Immediate bleeding;
  • Delayed bleeding;
  • Perforation;
  • Post-polypectomy syndrome;
  • Need for hospitalization;
  • Need for surgical intervention;
  1. Data Collection The following variables were collected: 7.1 Clinical
  • Age;
  • Sex;
  • Comorbidities;
  • Indication for colonoscopy; 7.2 Endoscopic
  • Lesion size;
  • Location;
  • Morphology;
  • Resection technique (en bloc vs. piecemeal); 7.3 Histological
  • Histological type;
  • Degree of dysplasia;
  • Presence of intramucosal carcinoma;
  • Classification as advanced histology;
  1. Statistical Analysis
  • The study was structured as a time-to-event analysis;
  • Estimation of cumulative recurrence incidence;
  • Kaplan-Meier curves for recurrence-free time analysis;
  • Comparison between groups using the log-rank test;
  • Cox regression models to identify independent predictors of recurrence;
  • Hazard Ratio (HR) calculation with 95% CI;
  • Significance level: p < 0.05;
  1. Relevant Methodological Aspects Consecutive inclusion to reduce selection bias. Standardization of endoscopic reports. Histopathological review according to institutional criteria. Objective definition of recurrence (histological confirmation).
  2. Expected Impact

This study will allow:

  • Identification of independent factors associated with local recurrence;
  • Better definition of the role of advanced histology as a risk marker;
  • Improvement of post-polypectomy surveillance intervals;
  • Consolidation of safety data in a real-world practice setting;
  • Contribution to the individualization of endoscopic follow-up.
Keywords
Colonoscopy, Snare polypectomy, Local recurrence, Advanced histology, Piecemeal resection, Time-to- event analysis
Medical subject headings
Colonic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local recurrence of the lesion at the site of the previous resection

    Presence of a visible lesion at the scar site of a previous polypectomy, histologically confirmed as adenomatous, serrated, or neoplastic tissue, obtained by biopsy or new resection.

    Measured: Between the years 2023 and 2025.

Secondary outcomes (2)
  1. Presence of metachronous adenoma

    Development of a new adenomatous or serrated lesion at a site different from the area of previous resection, identified during follow-up colonoscopy and confirmed histologically.

    Measured: Between the years 2023 and 2025.

  2. Adverse events related to the procedure

    Complications attributable to snare polypectomy, classified as: immediate bleeding; delayed bleeding; perforation; post-polypectomy syndrome (when applicable); and need for hospitalization or surgical intervention.

    Measured: Between the years 2023 and 2025.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start4 Dec 2025
  3. Primary completion15 Jan 2026
  4. Study completion24 Feb 2026

Resources

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
Retrospective
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07445178
Sponsor's protocol ID
8.027.384
Other IDs
94262925.8.0000.5440
Status last verified
Feb 2026
First submitted
24 Feb 2026
Last updated
3 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual patient data included in this study will not be shared with other researchers, as it contains sensitive clinical information obtained through medical record review and is protected by ethical and legal standards of confidentiality and data protection. Even after anonymization, sharing could represent a residual risk of re-identification, especially since it is a sample from a single center with specific clinical characteristics. Therefore, the restriction on external sharing aims to guarantee the privacy of participants, compliance with the guidelines of the Research Ethics Committee, and conformity with current data protection legislation.

Publications

  • Mohapatra S, Fukami N. Prevention of bleeding after EMR of colorectal lesions: when and how? Lancet Gastroenterol Hepatol. 2022 Feb;7(2):109-110. doi: 10.1016/S2468-1253(21)00463-5. No abstract available.

    PubMed 35026166
  • Albeniz E, Montori S, Rodriguez de Santiago E, Lorenzo-Zuniga V, Alvarez MA, Estremera-Arevalo F, Pohl H. Preventing Postendoscopic Mucosal Resection Bleeding of Large Nonpedunculated Colorectal Lesions. Am J Gastroenterol. 2022 Jul 1;117(7):1080-1088. doi: 10.14309/ajg.0000000000001819. Epub 2022 May 4.

    PubMed 35765907
  • Mack A, Mangira D, Moss A. Prevention of delayed post-polypectomy bleeding: Should we amend the 2017 ESGE Guideline? Endosc Int Open. 2020 Sep;8(9):E1111-E1114. doi: 10.1055/a-1196-1602. Epub 2020 Aug 31. No abstract available.

    PubMed 32898199
  • Burgess NG, Metz AJ, Williams SJ, Singh R, Tam W, Hourigan LF, Zanati SA, Brown GJ, Sonson R, Bourke MJ. Risk factors for intraprocedural and clinically significant delayed bleeding after wide-field endoscopic mucosal resection of large colonic lesions. Clin Gastroenterol Hepatol. 2014 Apr;12(4):651-61.e1-3. doi: 10.1016/j.cgh.2013.09.049. Epub 2013 Oct 1.

    PubMed 24090728
  • Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.

    PubMed 21392504
  • Facciorusso A, Di Maso M, Serviddio G, Vendemiale G, Spada C, Costamagna G, Muscatiello N. Factors Associated With Recurrence of Advanced Colorectal Adenoma After Endoscopic Resection. Clin Gastroenterol Hepatol. 2016 Aug;14(8):1148-1154.e4. doi: 10.1016/j.cgh.2016.03.017. Epub 2016 Mar 19.

    PubMed 27005802
  • Andrisani G, Hassan C, Pizzicannella M, Pugliese F, Mutignani M, Campanale C, Valerii G, Barbera C, Antonelli G, Di Matteo FM. Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial. Gastrointest Endosc. 2023 Dec;98(6):987-997.e1. doi: 10.1016/j.gie.2023.06.009. Epub 2023 Jun 28.

    PubMed 37390864
  • Le QD, Le NQ, Quach DT. Underwater vs conventional endoscopic mucosal resection for nonpedunculated colorectal neoplasms: A randomized controlled trial. World J Gastrointest Surg. 2025 Jun 27;17(6):103635. doi: 10.4240/wjgs.v17.i6.103635.

    PubMed 40584488
  • Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available.

    PubMed 32122632
  • Ma MX, Bourke MJ. Sessile Serrated Adenomas: How to Detect, Characterize and Resect. Gut Liver. 2017 Nov 15;11(6):747-760. doi: 10.5009/gnl16523.

    PubMed 28494577
  • von Renteln D, Djinbachian R, Benard F, Barkun AN, Bouin M, Bouchard S, Deslandres E, Panzini B, Sidani S, Leduc R, Jobse BC, Pohl H. Incomplete resection of colorectal polyps of 4-20 mm in size when using a cold snare, and its associated factors. Endoscopy. 2023 Oct;55(10):929-937. doi: 10.1055/a-1978-3277. Epub 2022 Nov 14.

    PubMed 36377124
  • Kandel P, Hussain M, Yadav D, Dhungana SK, Brahmbhatt B, Raimondo M, Lukens FJ, Bachuwa G, Wallace MB. Post-EMR for colorectal polyps, thermal ablation of defects reduces adenoma recurrence: A meta-analysis. Endosc Int Open. 2022 Oct 17;10(10):E1399-E1405. doi: 10.1055/a-1922-7646. eCollection 2022 Oct.

    PubMed 36262518
  • Makazu M, Sakamoto T, So E, Otake Y, Nakajima T, Matsuda T, Kushima R, Saito Y. Relationship between indeterminate or positive lateral margin and local recurrence after endoscopic resection of colorectal polyps. Endosc Int Open. 2015 Jun;3(3):E252-7. doi: 10.1055/s-0034-1391853. Epub 2015 May 5.

    PubMed 26171439
  • Gupta S, Demb J, Qin J, Earles A, Lamm M, Doubeni CA, Martinez ME, Kaltenbach TR, Gawron AJ, Shah SC, Messer K, Liu L. Impact of Guideline-Concordant Post-Polypectomy Colonoscopy Surveillance on Colorectal Cancer Incidence and Mortality. Clin Gastroenterol Hepatol. 2026 Jun;24(6):1709-1719. doi: 10.1016/j.cgh.2025.11.012. Epub 2025 Nov 24.

    PubMed 41297736
  • Sadowski DC, Kolber MR, Gomes A, Hickle L, Hilsden R, McLean DR, Mok D, Moysey B, Nemecek N, Ryan JD, Sultanian R, Wiseman J, Yang H. Post-polypectomy surveillance: follow-up recommendations from the Alberta Colorectal Cancer Screening Program. J Can Assoc Gastroenterol. 2024 Mar 19;7(4):319-328. doi: 10.1093/jcag/gwae007. eCollection 2024 Aug.

    PubMed 39139219

Questions about this trial

What is this clinical trial studying?

An observational study of Colo-rectal Cancer, run by University of Sao Paulo at 1 site in Brazil.

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 6 inclusion and 5 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: finished, as of the sponsor's last update on 3 Mar 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 Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local recurrence of the lesion at the site of the previous resection (time frame: Between the years 2023 and 2025.). 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 NCT07445178, which also lists 27 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 3 Mar 2026.

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