Post Polypectomy Bleeding. Que Sera, Sera? Whatever Will be, Will be?

NCT06220149 | Recruiting

• 1 other identifier: FILLIP
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with colorectal polyps removed endoscopically (polypectomy, endoscopic mucosal resection, underwater endoscopic mucosal resection, endoscopic submucosal dissection) may experience delayed post polypectomy bleeding. The incidence is about one in 40 cases. There are risks factors for this complication, depending on the polyp type, patient demographics and co-morbidities and polypectomy technique. There are meta-analysis and nomograms for risk prediction available. We will try to predict delayed post polypectomy bleeding by using FIT (fecal immunochemical test), with a cut-off adapted to detect post polypectomy bleeding, administered daily for 2 weeks after polypectomy.

Conditions

Polyp Colorectal; Bleeding

Outcome Measures

Primary Outcomes (1)

• Day of maximum probability of positive FIT to detect delayed post polypectomy bleeding

  Day (1 - 14) of positive FIT with maximum 24h before delayed post polypectomy bleeding

  14 days

Secondary Outcomes (2)

• Time to delayed post polypectomy bleeding

  14 days

• Time of FIT positivity after polypectomy with no delayed post polypectomy bleeding

  14 days

Study Arms (1)

Post polypectomy cohort

Diagnostic Test: FIT (fecal immunochemical test)

Interventions

FIT (fecal immunochemical test) DIAGNOSTIC_TEST

A FIT (fecal immunochemical test) will be done daily for the 14 days following polypectomy.

Post polypectomy cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient above 18 years old with the indication of colonoscopy, satisfying inclusion and exclusion criteria.

You may qualify if:

• Patient with at least one advanced adenoma \> 10mm diameter resected at colonoscopy by polypectomy, EMR, underwater EMR or ESD
• Age \> 18 years old
• Written informed consent.

You may not qualify if:

• Synchronous advanced colorectal cancer
• Synchronous unresected advanced adenomas
• Concomitant inflammatory bowel disease or any active colitis
• Absence of written informed consent

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

"Agrippa Ionescu" Hospital

Bucharest, Romania

RECRUITING

Related Publications (8)

• Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.

  PMID: 25681402 BACKGROUND

• 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.

  PMID: 28779355 BACKGROUND

• Huai J, Ye X, Ding J. Nomogram for the Prediction of Delayed Colorectal Post-Polypectomy Bleeding. Turk J Gastroenterol. 2021 Sep;32(9):727-734. doi: 10.5152/tjg.2021.20842.

  PMID: 34609301 BACKGROUND

• Lu Y, Zhou X, Chen H, Ding C, Si X. Establishment of a model for predicting delayed post-polypectomy bleeding: A real-world retrospective study. Front Med (Lausanne). 2022 Oct 19;9:1035646. doi: 10.3389/fmed.2022.1035646. eCollection 2022.

  PMID: 36341244 BACKGROUND

• Monahan KJ, Davies MM, Abulafi M, Banerjea A, Nicholson BD, Arasaradnam R, Barker N, Benton S, Booth R, Burling D, Carten RV, D'Souza N, East JE, Kleijnen J, Machesney M, Pettman M, Pipe J, Saker L, Sharp L, Stephenson J, Steele RJ. Faecal immunochemical testing (FIT) in patients with signs or symptoms of suspected colorectal cancer (CRC): a joint guideline from the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and the British Society of Gastroenterology (BSG). Gut. 2022 Jul 12;71(10):1939-62. doi: 10.1136/gutjnl-2022-327985. Online ahead of print.

  PMID: 35820780 BACKGROUND

• Mohan BP, Khan SR, Daugherty E, Chandan S, Ponnada S, Facciorusso A, Kassab LL, Asokkumar R, Adler DG. Pooled rates of adenoma detection by colonoscopy in asymptomatic average-risk individuals with positive fecal immunochemical test: a systematic review and meta-analysis. Gastrointest Endosc. 2022 Aug;96(2):208-222.e14. doi: 10.1016/j.gie.2022.04.004. Epub 2022 Apr 9.

  PMID: 35413330 BACKGROUND

• Pokharel R, Lin YS, McFerran E, O'Mahony JF. A Systematic Review of Cost-Effectiveness Analyses of Colorectal Cancer Screening in Europe: Have Studies Included Optimal Screening Intensities? Appl Health Econ Health Policy. 2023 Sep;21(5):701-717. doi: 10.1007/s40258-023-00819-3. Epub 2023 Jun 28.

  PMID: 37380865 BACKGROUND

• Mowat C, Digby J, Cleary S, Gray L, Datt P, Goudie DR, Steele RJ, Strachan JA, Humphries A, Fraser CG. Faecal haemoglobin concentration in adenoma, before and after polypectomy, approaches the ideal tumour marker. Ann Clin Biochem. 2022 Jul;59(4):272-276. doi: 10.1177/00045632221080897. Epub 2022 Mar 2.

  PMID: 35235491 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colorectal adenoma resected through different techniques (polypectomy, endoscopic mucosal resection, underwater endoscopic mucosal resection, endoscopic submucosal dissection)

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 23, 2024
• Study Start: May 6, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

RO (1)