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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Portsmouth Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01182623
First received: August 12, 2010
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Colonic Polyps
Other: Observation of surface patterns of polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polyp Surface Pattern Recognition in the Identification of Neoplastic Polyps

Resource links provided by NLM:


Further study details as provided by Portsmouth Hospitals NHS Trust:

Primary Outcome Measures:
  • The accuracy of predicted in-vivo polyp histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Sensitivity of white light endoscopy in predicting histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • specificity of white light endoscopy in predicting histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Sensitivity of Chromoendoscopy in predicting histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Specificity of Chromoendoscopy in predicting histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Sensitivity of fujinon intelligent color enhancement (FICE) in predicting histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Specificity of fujinon intelligent color enhancement (FICE) in predicting histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Whether one technique is superior [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 260
Study Start Date: December 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
examination of the surface patterns of polyps using FICE and indigo carmine dye spray

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing colonoscopy where one or more polyps are found.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient preference Clinicians judgement Obvious cancers Ulcerated polyps
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182623

Contacts
Contact: Pradeep Bhandari, MD, MRCP 02392286000 ext 6255 deep3570@yahoo.co.uk
Contact: Gaius Longcroft-Wheaton, MBBS, MRCP 02392286000 ext 6255 gaius@gaius.wanadoo.co.uk

Locations
United Kingdom
Portsmouth Hospitals NHS trust Recruiting
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Contact: Pradeep Bhandari, MBBS,MD,MRCP    02392286000 ext 6255    deep3570@yahoo.co.uk   
Contact: Gaius Longcroft-Wheaton, MBBS,MRCP    02392286000 ext 6255    gaius@gaius.wanadoo.co.uk   
Principal Investigator: Pradeep Bhandari, MBBS,MD,MRCP         
Sub-Investigator: Gaius Longcroft-Wheaton, MBBS,MRCP         
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Investigators
Principal Investigator: Pradeep Bhandari, MBBS,MD,MRCP Consultant gastroenterologist
  More Information

No publications provided

Responsible Party: Martine Cross, Portsmouth Hospitals NHS trust
ClinicalTrials.gov Identifier: NCT01182623     History of Changes
Other Study ID Numbers: PHT2009/046
Study First Received: August 12, 2010
Last Updated: August 17, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Portsmouth Hospitals NHS Trust:
FICE
Chromoendoscopy
Colonic polyps
Adenomas
Hyperplastic polyps

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 28, 2014