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Recruiting NCT06476145

Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation

— Observational Adenoma Colon Polyp

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Adenoma Colon Polyp. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation

Overview

Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)

Primary outcome measures

  • Adenoma Reocurrance [Time frame: 3 - 12 (+/- 6 months)]
Secondary outcome measures (5)
  • EMR procedure time [Time frame: During procedure visit]
  • Comparison of MM vs STSC procedure time [Time frame: Index procedure visit]
  • Incidence of overall severe adverse events: Bleeding [Time frame: Index procedure, 1 - 3 days post, 30 days.]
  • Incidence of overall severe adverse events: Perforation [Time frame: Index procedure, 1 - 3 days post, 30 days.]
  • Incidence of overall severe adverse events: Postpolypectomy Syndrome [Time frame: Index procedure, 1 - 3 days post, 30 days.]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older
  • Ability to provide informed consent
  • Patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps
  • Non-pedunculated polyps ≥ 20 mm size

Exclusion criteria

  • Pedunculated polyps
  • Inflammatory bowel disease
  • Inability to provide informed consent
  • Lesions < 20 mm in size (largest dimension)
  • Lesion involves the lips of the ileocecal valve, is located at the appendiceal orifice and/or is fully circumferential.
  • Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • AdventHealth — Orlando

Publications

  • Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370. PMID 22356322
  • Jayanna M, Burgess NG, Singh R, Hourigan LF, Brown GJ, Zanati SA, Moss A, Lim J, Sonson R, Williams SJ, Bourke MJ. Cost Analysis of Endoscopic Mucosal Resection vs Surgery for Large Laterally Spreading Colorectal Lesions. Clin Gastroenterol Hepatol. 2016 Feb;14(2):271-8.e1-2. doi: 10.1016/j.cgh.2015.08.037. Epub 2015 Sep 11. PMID 26364679
  • Ahlenstiel G, Hourigan LF, Brown G, Zanati S, Williams SJ, Singh R, Moss A, Sonson R, Bourke MJ; Australian Colonic Endoscopic Mucosal Resection (ACE) Study Group. Actual endoscopic versus predicted surgical mortality for treatment of advanced mucosal neoplasia of the colon. Gastrointest Endosc. 2014 Oct;80(4):668-676. doi: 10.1016/j.gie.2014.04.015. Epub 2014 Jun 7. PMID 24916925
  • Brooker JC, Saunders BP, Shah SG, Thapar CJ, Suzuki N, Williams CB. Treatment with argon plasma coagulation reduces recurrence after piecemeal resection of large sessile colonic polyps: a randomized trial and recommendations. Gastrointest Endosc. 2002 Mar;55(3):371-5. doi: 10.1067/mge.2002.121597. PMID 11868011
  • 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. PMID 21392504
  • Arebi N, Swain D, Suzuki N, Fraser C, Price A, Saunders BP. Endoscopic mucosal resection of 161 cases of large sessile or flat colorectal polyps. Scand J Gastroenterol. 2007 Jul;42(7):859-66. doi: 10.1080/00365520601137280. PMID 17558911
  • Kandel P, Werlang ME, Ahn IR, Woodward TA, Raimondo M, Bouras EP, Wallace MB, Gomez V. Prophylactic Snare Tip Soft Coagulation and Its Impact on Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Dig Dis Sci. 2019 Nov;64(11):3300-3306. doi: 10.1007/s10620-019-05666-8. Epub 2019 May 16. PMID 31098871
  • Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6. PMID 30296436

Identifiers

NCT: NCT06476145 · 1880214

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗