Follow-up Protocol of Colorectal Endoscopic Mucosal Resection Scars

NCT04239365 | Completed

• 1 other identifier: PortugueseOIC 004
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays endoscopic mucosal resection (EMR) is the gold standard for the removal of large laterally spreading and sessile colorectal lesions ≥ 20 mm. However, recurrence rate after successful EMR (defined by the absence of neoplastic tissue at the completion of the procedure after careful inspection of the post-EMR mucosal defect and margin) is about 15-20%. Consequently, current guidelines recommend a surveillance colonoscopy between 4 and 6 months after resection for detection of residual or recurrent polyp. There are few studies that have examined the accuracy of advanced endoscopic imaging for the prediction of histological recurrence but none of these imaging modalities have been validated for surveillance after EMR. Therefore, current guidelines strongly recommend systematic biopsy of EMR scar. The main aim of this study is to assess the incremental benefit of narrow band imaging (NBI) and white light endoscopy (WLE) randomizing the initial technique for the endoscopic detection of post-EMR recurrence and to asses if this advanced imaging method achieve sufficient diagnostic accuracy to exclude recurrence without the need for biopsy.

Conditions

Colorectal Cancer; Recurrence, Local Neoplasm

Keywords

recurrence; endoscopic mucosal resection; colorectal lesions; advanced endoscopic imaging

Outcome Measures

Primary Outcomes (4)

• Diagnostic performance of WLE and NBI for each group

  Sensitivity, specificity, negative predictive value, positive predictive value and accuracy of NBI and WLE for each group calculated using 2x2 contingency tables

  1 day (at the time of data analysis)

• Recurrent adenoma - WLE

  WLE recurrent adenoma identification for each group

  1 day (during colonoscopy)

• Recurrent adenoma - NBI

  NBI recurrent adenoma identification for each group

  1 day (during colonoscopy)

• Recurrent adenoma - histology

  Adenoma recurrence confirmed by histology

  1 day (within 30 days from colonoscopy)

Secondary Outcomes (2)

• Lesion characterization at the baseline colonoscopy

  1 day (at the time of patient inclusion)

• Scar characterization at the first surveillance colonoscopy

  1 day (immediately after first surveillance colonoscopy)

Study Arms (2)

Group A: WLE followed by NBI

EXPERIMENTAL

EMR scar is interrogated using WLE followed by NBI

Diagnostic Test: WLE followed by NBI or NBI followed by WLE (crossover design)

Group B: NBI followed by WLE

ACTIVE COMPARATOR

EMR scar is interrogated using NBI followed by WLE

Diagnostic Test: WLE followed by NBI or NBI followed by WLE (crossover design)

Interventions

WLE followed by NBI or NBI followed by WLE (crossover design) DIAGNOSTIC_TEST

EMR scar is inspected using WLE followed by NBI or vice versa

Also known as: WLE followed by NBI or NBI followed by WLE

Group A: WLE followed by NBI; Group B: NBI followed by WLE

Eligibility Criteria

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

You may qualify if:

• patients undergoing the first follow-up surveillance colonoscopy after successful EMR of colorectal lesion.

You may not qualify if:

• informed consent not provided,
• inflammatory bowel disease, inadequate bowel preparation (Boston Bowel Preparation Scale total score \< 6 or \< 2 in a segment),
• EMR scar not identified during colonoscopy,
• tissue acquisition unfeasibly.

Sponsors & Collaborators

• Portuguese Oncology Institute, Coimbra: lead

Study Sites (1)

Portuguese Oncology Institute - Coimbra

Coimbra, 3001 - 651, Portugal

Location

Related Publications (10)

• Rembacken B, Hassan C, Riemann JF, Chilton A, Rutter M, Dumonceau JM, Omar M, Ponchon T. Quality in screening colonoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE). Endoscopy. 2012 Oct;44(10):957-68. doi: 10.1055/s-0032-1325686. Epub 2012 Sep 17. No abstract available.

  PMID: 22987217 BACKGROUND

• 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.

  PMID: 27908600 BACKGROUND

• Hassan C, Quintero E, Dumonceau JM, Regula J, Brandao C, Chaussade S, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gimeno-Garcia A, Hazewinkel Y, Jover R, Kalager M, Loberg M, Pox C, Rembacken B, Lieberman D; European Society of Gastrointestinal Endoscopy. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2013 Oct;45(10):842-51. doi: 10.1055/s-0033-1344548. Epub 2013 Sep 12.

  PMID: 24030244 BACKGROUND

• Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.

  PMID: 28212588 BACKGROUND

• Desomer L, Tutticci N, Tate DJ, Williams SJ, McLeod D, Bourke MJ. A standardized imaging protocol is accurate in detecting recurrence after EMR. Gastrointest Endosc. 2017 Mar;85(3):518-526. doi: 10.1016/j.gie.2016.06.031. Epub 2016 Jun 22.

  PMID: 27343411 BACKGROUND

• Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.

  PMID: 30635409 BACKGROUND

• Riu Pons F, Andreu M, Gimeno Beltran J, Alvarez-Gonzalez MA, Seoane Urgorri A, Dedeu JM, Barranco Priego L, Bessa X. Narrow band imaging and white light endoscopy in the characterization of a polypectomy scar: A single-blind observational study. World J Gastroenterol. 2018 Dec 7;24(45):5179-5188. doi: 10.3748/wjg.v24.i45.5179.

  PMID: 30568394 BACKGROUND

• Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.

  PMID: 23910062 BACKGROUND

• The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc. 2003 Dec;58(6 Suppl):S3-43. doi: 10.1016/s0016-5107(03)02159-x. No abstract available.

  PMID: 14652541 BACKGROUND

• Joao M, Areia M, Pinto-Pais T, Gomes LC, Saraiva S, Alves S, Elvas L, Brito D, Saraiva S, Teixeira-Pinto A, Claro I, Dinis-Ribeiro M, Cadime AT. Can white-light endoscopy or narrow-band imaging avoid biopsy of colorectal endoscopic mucosal resection scars? A multicenter randomized single-blind crossover trial. Endoscopy. 2023 Jul;55(7):601-607. doi: 10.1055/a-2018-1612. Epub 2023 Jan 23.

  PMID: 36690030 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Recurrence, Local; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Miguel Areia, PhD

  Gastroenterology Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 27, 2020
• Study Start: January 31, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

PT (1)