Small Hyperplastic and Adenomatous Reliability Protocol

NCT ID: NCT01675752

Last Updated: 2012-08-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-07-31

Brief Summary

1. Protocol Summary Title: SHARP: Small Hyperplastic and Adenomatous Reliability Protocol Purpose: To compare the accuracy of NBI-in vivo differentiation between hyperplastic and adenomatous <10 mm polyps with that of histology in an European multi-center study. To assess variability among endoscopists in NBI accuracy. We also aim to assess whether this technology impacts the appropriateness of surveillance intervals.

Design: 1) Before starting the patient enrollment, the participating endoscopists will attend an internet-based training program on the in vivo differentiation between hyperplastic and adenomatous polyps. Following this course, a qualifying examination will be required for each endoscopist to be included.

2) Patients who are scheduled for screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified <10 mm polyp will be included. In order to measure NBI feasibility, each included polyp will be in vivo assessed by NBI in order to rank between a high- and a low- level of diagnostic confidence, and thereafter will be sent for histological assessment. NBI- and histological accuracy in differentiating between hyperplastic and adenomatous lesions will be analyzed and compared, in order to assess the NBI-sensitivity and specificity. The primary outcomes are to measure the NBI feasibility and accuracy in the study population, and to assess the variability among the endoscopists. Secondary outcome measures will be a cost analysis on how much savings would be achieved by not referring NBI-diagnosed hyperplastic polyps to histology, and a clinical inference on how many patients would be scheduled for an inappropriate post-polypectomy follow up, when follow up schedule is based on NBI classification. Clinical results will be analyzed using various statistical measures of significance.

Clinical Site Locations: 10 European centres with NBI-technology

1 NBI-expert endoscopist for each centre Enrollment: 160 small (<10 mm) polyps at each site Study technology: NBI-Olympus without optical magnification Risk: Non-interventional study.

Conditions

Adenomatous Polyp

Keywords

colonoscopy, narrow-band imaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. The patient is at satisfactory risk to undergo abdominal surgery; 3. The patient must understand and provide written consent for the procedure.

Exclusion Criteria

• 1. The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up; 2. The patient is at satisfactory risk to undergo abdominal surgery; 3. The patient must understand and provide written consent for the procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Olympus

INDUSTRY

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Repici A, Hassan C, Radaelli F, Occhipinti P, De Angelis C, Romeo F, Paggi S, Saettone S, Cisaro F, Spaander M, Sharma P, Kuipers EJ. Accuracy of narrow-band imaging in predicting colonoscopy surveillance intervals and histology of distal diminutive polyps: results from a multicenter, prospective trial. Gastrointest Endosc. 2013 Jul;78(1):106-14. doi: 10.1016/j.gie.2013.01.035. Epub 2013 Apr 11.

Reference Type: DERIVED

PMID: 23582472 (View on PubMed)

Other Identifiers

CE ICH 37/11

Identifier Type: -

Identifier Source: org_study_id