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

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ClinicalTrials.gov Identifier: NCT01182623
Recruitment Status : Unknown
Verified August 2010 by Portsmouth Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : August 17, 2010
Last Update Posted : August 18, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Colonic Polyps Other: Observation of surface patterns of polyps

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Polyp Surface Pattern Recognition in the Identification of Neoplastic Polyps
Study Start Date : December 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The accuracy of predicted in-vivo polyp histology [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. • Sensitivity of white light endoscopy in predicting histology [ Time Frame: 9 months ]
  2. specificity of white light endoscopy in predicting histology [ Time Frame: 9 months ]
  3. Sensitivity of Chromoendoscopy in predicting histology [ Time Frame: 9 months ]
  4. Specificity of Chromoendoscopy in predicting histology [ Time Frame: 9 months ]
  5. Sensitivity of fujinon intelligent color enhancement (FICE) in predicting histology [ Time Frame: 9 months ]
  6. Specificity of fujinon intelligent color enhancement (FICE) in predicting histology [ Time Frame: 9 months ]
  7. Whether one technique is superior [ Time Frame: 9 months ]

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Martine Cross, Portsmouth Hospitals NHS trust
ClinicalTrials.gov Identifier: NCT01182623     History of Changes
Other Study ID Numbers: PHT2009/046
First Posted: August 17, 2010    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: August 2010

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

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