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

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
WLE
NBI
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring endoscopic mucosal resection, piecemeal polypectomy scar, colorectal neoplasms, Narrow Band Imaging, chromoendoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital del Mar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

WLE-NBI

NBI-WLE

Arm Description

Participants will be evaluated by same endoscopist, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly High Definition White Light Endoscopy (WLE) and secondly Narrow Band Imaging. All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.

Participants will be evaluated by same endoscopist, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly Narrow Band Imaging and secondly High Definition White Light Endoscopy (WLE). All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.

Outcomes

Primary Outcome Measures

Number of residual neoplastic tissue detected with both techniques (NBI versus WLE)
Efficacy of NBI in detecting residual neoplasia compared with WLE

Secondary Outcome Measures

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)
Number of missed lesions on basal colonoscopy
Compare the number of missed lesions from the basal colonoscopy

Full Information

First Posted
May 15, 2015
Last Updated
May 3, 2016
Sponsor
Parc de Salut Mar
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1. Study Identification

Unique Protocol Identification Number
NCT02448693
Brief Title
Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection
Acronym
CROMOPIE
Official Title
Randomised Tandem Colonoscopy of Narrow Band Imaging (NBI) and White Light Endoscopy in Patients With Endoscopic Piecemeal Mucosal Resection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
endoscopic mucosal resection, piecemeal polypectomy scar, colorectal neoplasms, Narrow Band Imaging, chromoendoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WLE-NBI
Arm Type
Experimental
Arm Description
Participants will be evaluated by same endoscopist, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly High Definition White Light Endoscopy (WLE) and secondly Narrow Band Imaging. All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.
Arm Title
NBI-WLE
Arm Type
Experimental
Arm Description
Participants will be evaluated by same endoscopist, tandem colonoscopy. It consists of two revisions of the polypectomy scar using firstly Narrow Band Imaging and secondly High Definition White Light Endoscopy (WLE). All suspected neoplasia will be classified macroscopically and resected and differentiated from both techniques. The rest of the gut will be inspected following conventional standards.
Intervention Type
Device
Intervention Name(s)
WLE
Other Intervention Name(s)
High Definition colonoscopy with White Light Endoscopy (WLE)
Intervention Description
Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)
Intervention Type
Device
Intervention Name(s)
NBI
Other Intervention Name(s)
Narrow Band Imaging
Intervention Description
Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).
Primary Outcome Measure Information:
Title
Number of residual neoplastic tissue detected with both techniques (NBI versus WLE)
Description
Efficacy of NBI in detecting residual neoplasia compared with WLE
Time Frame
less than 1 year after the basal colonoscopy
Secondary Outcome Measure Information:
Title
Number of accurate detection of residual neoplastic tissue with morphologic features in both groups (NBI and WLE) compared with histopathology
Description
Accuracy in detecting neoplastic tissue endoscopically compared with histopathology (gold standard)
Time Frame
less than 1 year after the basal colonoscopy
Title
Number of missed lesions on basal colonoscopy
Description
Compare the number of missed lesions from the basal colonoscopy
Time Frame
less than 1 year after the basal colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fausto Riu, MD
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12196768
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. doi: 10.1016/s0016-5107(02)70034-5.
Results Reference
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PubMed Identifier
11740641
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. doi: 10.1055/s-2001-18932.
Results Reference
background
PubMed Identifier
24639382
Citation
Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise 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.
Results Reference
background
PubMed Identifier
19249767
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.
Results Reference
background
PubMed Identifier
23012119
Citation
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. doi: 10.1055/s-0032-1309821. Epub 2012 Sep 25.
Results Reference
background
PubMed Identifier
22763141
Citation
Lieberman DA, Rex DK, Winawer SJ, Giardiello FM, Johnson DA, Levin TR. 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):844-857. doi: 10.1053/j.gastro.2012.06.001. Epub 2012 Jul 3. No abstract available.
Results Reference
background
PubMed Identifier
15306595
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. doi: 10.1136/gut.2003.036913.
Results Reference
background
PubMed Identifier
20532981
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.
Results Reference
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Study of Narrow Band Imaging in the Characterization of Residual Neoplasia After Endoscopic Piecemeal Mucosal Resection

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