The Value of Polyp Surface Pattern Recognition in the Identification of Neoplasia: a Prospective Study

NCT01182623 | Completed

• 1 other identifier: PHT2009/046
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

It is current practice to remove any polyps found during colonoscopy. This is because adenomatous polyps have the potential to turn into cancer. However, a proportion of polyps \<10mm in size are hyperplastic, which cannot turn into cancer. Current practice requires these to be removed, as it is traditionally felt that they cannot be separated clinically from adenomas. This increases the risk of perforation and results in a significant cost in processing the samples. However, it has been suggested that it is possible to differentiate neoplastic from non neoplastic lesions using skills in polyp surface pattern recognition. If this is the case the investigators may be able to reduce the need for polypectomy The investigators believe that it is possible to tell the difference between polyps with cancerous potential and those that are harmless by assessment of surface patterns. This may enable us to improve the investigators clinical decisions when assessing polyps during colonoscopy, and reduce the number of unnecessary polypectomys being performed.

Conditions

Colonic Polyps

Keywords

FICE; Chromoendoscopy; Colonic polyps; Adenomas; Hyperplastic polyps

Outcome Measures

Primary Outcomes (1)

• The accuracy of predicted in-vivo polyp histology

  9 months

Secondary Outcomes (7)

• • Sensitivity of white light endoscopy in predicting histology

  9 months

• specificity of white light endoscopy in predicting histology

  9 months

• Sensitivity of Chromoendoscopy in predicting histology

  9 months

• Specificity of Chromoendoscopy in predicting histology

  9 months

• Sensitivity of fujinon intelligent color enhancement (FICE) in predicting histology

  9 months

Study Arms (1)

In vivo diagnosis

Patients undergoing colonoscopy where one or more polyps up to 10mm in size are found.

Other: Observation of surface patterns of polyps

Interventions

Observation of surface patterns of polyps OTHER

examination of the surface patterns of polyps using FICE and indigo carmine dye spray

In vivo diagnosis

Eligibility Criteria

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

Study Population

Patients undergoing colonoscopy where one or more polyps are found.

You may qualify if:

• Patients found to have polyps up to 10 mm in size

You may not qualify if:

• Patient preference Clinicians judgement Obvious cancers Ulcerated polyps

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals NHS trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

All polyps are sent for histological analysis as per standard protocol. This is not additional for the study and part of routine NHS practice. They will be kept and stored as per standard NHS protocols.

MeSH Terms

Conditions

Colonic Polyps; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Pradeep Bhandari, MBBS,MD,MRCP

  Consultant gastroenterologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 17, 2010
• Study Start: December 1, 2009
• Primary Completion: September 30, 2010
• Study Completion: September 30, 2010
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

GB (1)