Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection

Colorectal Neoplasms Clinical Trial

— CROMOPIE  

Official title:

Randomised Tandem Colonoscopy of Narrow Band Imaging (NBI) and White Light Endoscopy in Patients With Endoscopic Piecemeal Mucosal Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448693
• Other study ID #: CROMOPIE
• Status: Completed
• Phase: N/A
• First received: May 15, 2015
• Last updated: May 3, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the diagnostic accuracy of Narrow Band Imaging (NBI) compared with High Definition White Light colonoscopy (WLE) for detection of residual neoplasia in subjects with piecemeal polypectomy scars.

Description:

Resection of large sessile polyps in the colon (usually more than 2 cm) or those nonpolypoid neoplastic lesions (also called laterally spreading tumors or LST), confers technical difficulty and often are forced to remove into fragmented resection or endoscopic piecemeal mucosal resection. This has been associated with a recurrence of 25%. For this reason, clinical guidelines recommend endoscopic follow-up at 2 to 6 months after piecemeal resection of colorectal polyps to check for residual neoplasia.

Narrow-Band Imaging (NBI, Olympus) improves visibility and identification of the surface and vascular structures of colon polyps. In contrast to conventional chromoendoscopy, it is easily activated by pressing a button on the endoscope.

Virtual or conventional chromoendoscopy are applied during resection of polyps defining the border of the lesion. However, there are few studies using Narrow Band Imaging and do not allow to know whether the use of this technique could improve the detection of residual tumor after fragmented polypectomy and avoid complications, time and costs of biopsy and histological analysis.

In this context, the European Society of Gastrointestinal Endoscopy (ESGE) has recently published the first Guideline of Advanced Endoscopic Imaging for the Detection and Differentiation of Colorectal Neoplasia and recommends conventional or virtual chromoendoscopy in patients with piecemeal polypectomy scar (strong recommendation, low quality evidence).

The investigators will perform a randomised, controlled trial of tandem colonoscopy using NBI and WLE. The main goal is to compare the rate of detected neoplasia between both techniques and evaluate the diagnostic accuracy of NBI and WLE to histology as the gold standard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years old who underwent a colonoscopy for any reason in the last 12 month

• Patients with a basal colonoscopy findings: =1 polyp removed in a piecemeal fashion regardless of the size

Exclusion Criteria:

• Diagnosis of a CRC in the basal colonoscopy

• Subjects who neglect to follow-up

• Subjects who do not accept informed consent

• Subjects with high risk of perforation or complications due to sedation, including patients with comorbidities (ASA IV-V)

• Inadequate bowel preparation for colonoscopy (defined by Boston Bowel Preparation Score (BBPS): = 5 total points; or 0-1 points in any of the 3 segments of the colon)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• WLE
Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)
• NBI
Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Atkin WS, Valori R, Kuipers EJ, Hoff G, Senore C, Segnan N, Jover R, Schmiegel W, Lambert R, Pox C; International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Colonoscopic surveillance following adenoma removal. Endoscopy. 2012 Sep;44 Suppl 3:SE151-63. Epub 2012 Sep 25. — View Citation

Brooker JC, Saunders BP, Shah SG, Thapar CJ, Thomas HJ, Atkin WS, Cardwell CR, Williams CB. Total colonic dye-spray increases the detection of diminutive adenomas during routine colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2002 Sep;56(3):333-8. — View Citation

Hurlstone DP, Sanders DS, Cross SS, Adam I, Shorthouse AJ, Brown S, Drew K, Lobo AJ. Colonoscopic resection of lateral spreading tumours: a prospective analysis of endoscopic mucosal resection. Gut. 2004 Sep;53(9):1334-9. — View Citation

Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellisé M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17. — View Citation

Khashab M, Eid E, Rusche M, Rex DK. Incidence and predictors of "late" recurrences after endoscopic piecemeal resection of large sessile adenomas. Gastrointest Endosc. 2009 Aug;70(2):344-9. doi: 10.1016/j.gie.2008.10.037. Epub 2009 Feb 27. — View Citation

Kiesslich R, von Bergh M, Hahn M, Hermann G, Jung M. Chromoendoscopy with indigocarmine improves the detection of adenomatous and nonadenomatous lesions in the colon. Endoscopy. 2001 Dec;33(12):1001-6. — View Citation

Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR; United States Multi-Society Task Force on Colorectal Cancer. Guidelines for colonoscopy surveillance after screening and polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2012 Sep;143(3):844-57. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. Review. — View Citation

Rogart JN, Aslanian HR, Siddiqui UD. Narrow band imaging to detect residual or recurrent neoplastic tissue during surveillance endoscopy. Dig Dis Sci. 2011 Feb;56(2):472-8. doi: 10.1007/s10620-010-1289-z. Epub 2010 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of residual neoplastic tissue detected with both techniques (NBI versus WLE)	Efficacy of NBI in detecting residual neoplasia compared with WLE	less than 1 year after the basal colonoscopy	No
Secondary	Number of accurate detection of residual neoplastic tissue with morphologic features in both groups (NBI and WLE) compared with histopathology	Accuracy in detecting neoplastic tissue endoscopically compared with histopathology (gold standard)	less than 1 year after the basal colonoscopy	No
Secondary	Number of missed lesions on basal colonoscopy	Compare the number of missed lesions from the basal colonoscopy	less than 1 year after the basal colonoscopy	No