- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445178
Piecemeal Resection and Advanced Histology Independently Predict Local Recurrence After Colorectal Snare-based Endoscopic Resection: a Time-to-event Cohort 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.
Study Overview
Status
Conditions
Detailed Description
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.
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;
- 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.
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;
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.
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;
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;
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;
- 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).
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14048-900
- Hospital das Clínicas of Ribeirão Preto Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.);
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Local recurrence of the lesion at the site of the previous resection
Time Frame: Between the years 2023 and 2025.
|
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.
|
Between the years 2023 and 2025.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of metachronous adenoma
Time Frame: Between the years 2023 and 2025.
|
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.
|
Between the years 2023 and 2025.
|
|
Adverse events related to the procedure
Time Frame: Between the years 2023 and 2025.
|
Complications attributable to snare polypectomy, classified as: immediate bleeding; delayed bleeding; perforation; post-polypectomy syndrome (when applicable); and need for hospitalization or surgical intervention.
|
Between the years 2023 and 2025.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dekker E, Tanis PJ, Vleugels JLA, Kasi PM, Wallace MB. Colorectal cancer. Lancet. 2019 Oct 19;394(10207):1467-1480. doi: 10.1016/S0140-6736(19)32319-0.
- 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.
- Belderbos TD, Leenders M, Moons LM, Siersema PD. Local recurrence after endoscopic mucosal resection of nonpedunculated colorectal lesions: systematic review and meta-analysis. Endoscopy. 2014 May;46(5):388-402. doi: 10.1055/s-0034-1364970. Epub 2014 Mar 26.
- 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.
- Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. 2025 Nov 24:S1542-3565(25)00996-6. doi: 10.1016/j.cgh.2025.11.012. Online ahead of print.
- 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.
- Jaruvongvanich V, Prasitlumkum N, Assavapongpaiboon B, Suchartlikitwong S, Sanguankeo A, Upala S. Risk factors for delayed colonic post-polypectomy bleeding: a systematic review and meta-analysis. Int J Colorectal Dis. 2017 Oct;32(10):1399-1406. doi: 10.1007/s00384-017-2870-0. Epub 2017 Aug 5.
- Causada-Calo N, Bishay K, Albashir S, Al Mazroui A, Armstrong D. Association Between Age and Complications After Outpatient Colonoscopy. JAMA Netw Open. 2020 Jun 1;3(6):e208958. doi: 10.1001/jamanetworkopen.2020.8958.
- Harrington LX, Wei JW, Suriawinata AA, Mackenzie TA, Hassanpour S. Predicting colorectal polyp recurrence using time-to-event analysis of medical records. AMIA Jt Summits Transl Sci Proc. 2020 May 30;2020:211-220. eCollection 2020.
- Tate DJ, Desomer L, Klein A, Brown G, Hourigan LF, Lee EY, Moss A, Ormonde D, Raftopoulos S, Singh R, Williams SJ, Zanati S, Byth K, Bourke MJ. Adenoma recurrence after piecemeal colonic EMR is predictable: the Sydney EMR recurrence tool. Gastrointest Endosc. 2017 Mar;85(3):647-656.e6. doi: 10.1016/j.gie.2016.11.027. Epub 2016 Nov 28.
- Baile-Maxia S, Mangas-Sanjuan C, Ladabaum U, Hassan C, Rutter MD, Bretthauer M, Medina-Prado L, Sala-Miquel N, Pomares OM, Zapater P, Jover R. Risk Factors for Metachronous Colorectal Cancer or Advanced Adenomas After Endoscopic Resection of High-risk Adenomas. Clin Gastroenterol Hepatol. 2023 Mar;21(3):630-643. doi: 10.1016/j.cgh.2022.12.005. Epub 2022 Dec 20.
- Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.
- Ferlitsch M, Hassan C, Bisschops R, Bhandari P, Dinis-Ribeiro M, Risio M, Paspatis GA, Moss A, Libanio D, Lorenzo-Zuniga V, Voiosu AM, Rutter MD, Pellise M, Moons LMG, Probst A, Awadie H, Amato A, Takeuchi Y, Repici A, Rahmi G, Koecklin HU, Albeniz E, Rockenbauer LM, Waldmann E, Messmann H, Triantafyllou K, Jover R, Gralnek IM, Dekker E, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2024. Endoscopy. 2024 Jul;56(7):516-545. doi: 10.1055/a-2304-3219. Epub 2024 Apr 26.
- Liao Z, Guo JT, Yang F, Wang SP, Sun SY. Screening of colorectal cancer: Methods and strategies. World J Clin Oncol. 2024 Jul 24;15(7):799-805. doi: 10.5306/wjco.v15.i7.799.
- Crockett SD, Nagtegaal ID. Terminology, Molecular Features, Epidemiology, and Management of Serrated Colorectal Neoplasia. Gastroenterology. 2019 Oct;157(4):949-966.e4. doi: 10.1053/j.gastro.2019.06.041. Epub 2019 Jul 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8.027.384
- 94262925.8.0000.5440 (Other Identifier: Research Ethics Committee of the Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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