Colon PolypsNCT01214031
Prospective Study for Evaluating Colon Polyp Histology With in Vivo Probe Based Confocal Laser Endomicroscopy
A study testing Confocal laser endomicroscopy (CLE) in people with Colon Polyps and Adenomatous Polyps, run by Midwest Biomedical Research at 1 site in United States.
Trial summary
Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with magnification has been utilized for polyp histology identification. Pit patterns on the surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy in differentiating the polyp types (18, 19). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colon Polyps, Adenomatous Polyps, Colon Cancer
- What is being tested?
- Confocal laser endomicroscopy (CLE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.
Who cannot join
- prior surgical resection of any portion of colon, prior history of colon cancer, history of inflammatory bowel disease, use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure, poor general condition or any other reason to avoid prolonged procedure time, history of polyposis syndrome or HNPCC, inability to give informed consent, inadequate bowel preparation, allergy to fluorescein, pregnancy, and renal insufficiency.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center
Kansas City, Missouri, 64128
Sydney S Johnson, MBBS, 816-861-4700 ext. 56428, sydney.johnson@va.gov
About this study
Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with magnification has been utilized for polyp histology identification. Pit patterns on the surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy in differentiating the polyp types (18, 19). NBI, that is also referred to as "electronic chromoendoscopy" is another technique that has been evaluated for polyp histology identification by highlighting the superficial mucosal and vascular architecture (15, 20, 21). pCLE is another novel addition to the technologies aiming to accomplish in vivo histologic diagnosis with a high degree of accuracy. The pCLE system has three major components (Mauna Kea Technologies, Paris, France). The first is the confocal miniprobe made of approximately thirty thousand optical fibers bundled together and terminated by a distal microsystem. The images obtained have a lateral resolution of 1µm, an axial resolution of 10 µm and a maximum field of view of 240 µm. The depth of observation is from 55 to 65 µm. The miniprobe tip diameter is 2.5 mm and can be passed through the accessory channel of any standard endoscope. The second is the laser scanning unit (excitation wavelength - 488 nm) that combines the functions of laser light illumination and rapid laser scanning, enabling a frame rate up to 12 images per second and signal detection. The third is the control and acquisition software for real time image reconstruction, immediate sequences display and post-procedure analysis and editing tools. Once an area of interest (e.g. a polyp) is identified, 5 ml of 10% fluorescein sodium is injected intravenously; the confocal probe is passed through the accessory channel of the endoscope and placed against the lesion to obtain several high-quality images and video sequences. In a study by Buchner et al from the Mayo Clinic, Jacksonville, (22) this system was used to evaluate confocal images of 37 polyps from 25 patients in a blinded fashion without the knowledge of their histologic diagnosis or endoscopic appearance. The investigators developed the following criteria that were suggestive of neoplastic polyps: villiform pattern, nuclear characteristics - oval/irregular nuclear shape and increased number of nuclei. These features had a sensitivity of 82.6%, specificity of 92.9% and accuracy of 86.5% for the characterization of neoplastic polyps. Similarly, Meining et al (23) have also evaluated criteria for differentiating neoplastic from benign lesions in the colon with encouraging results.
The investigators hypothesize that pCLE will have a high rate for accurate characterization of polyp histology real time during colonoscopy
Read the detailed description
This study will be conducted at the Kansas City VA Medical Center, Kansas City, MO. The investigators have the pCLE system that the investigators are currently using in a multicenter study evaluating patients with Barrett's esophagus. Patients referred for screening and/or surveillance colonoscopy will be prospectively enrolled in this study. Inclusion criteria - referral for screening and/or surveillance colonoscopy and the ability to provide informed consent. Exclusion criteria: prior surgical resection of any portion of colon, prior history of colon cancer, history of inflammatory bowel disease, use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure, poor general condition or any other reason to avoid prolonged procedure time, history of polyposis syndrome or HNPCC, inability to give informed consent, inadequate bowel preparation, allergy to fluorescein, pregnancy, and renal insufficiency. Moderate sedation for the procedure will be administered in a standard fashion with intravenous midazolam, meperidine or fentanyl. This will be a single arm study with all procedures being performed with a standard white light colonoscope (CF - H180AL, Olympus America). After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal under high-definition white light and if a polyp is detected, its characteristics will be documented: size, location, and morphology [Polypoid (sessile, pedunculated) or Non-polypoid: (superficial elevated, completely flat, depressed)]. Then 5ml of 10% fluorescein sodium will be injected intravenously. Following this the pCLE probe will be passed through the biopsy channel of the colonoscope and placed on the polyp to obtain confocal images and video sequences. During the initial phase unblinded comparisons of the confocal images and videos with the polyp histology (20 adenomas, 20 hyperplastic) will be performed in order to evaluate the criteria described by the Mayo Jacksonville group (22) that differentiate between neoplastic and non neoplastic polyps. Following this initial phase, these criteria will be applied in a prospective manner to predict polyp histology (100 polyps) real time during the procedure prior to their removal. Multiple confocal images and videos of each polyp will be saved with appropriate labeling. Pathologists will be blinded to the endoscopic and pCLE findings of the polyps. Polyp size will be assessed by comparing with sheath of a polypectomy snare or open span of a biopsy forceps. Photo documentation of the polyps will be performed. Polyps will then be removed in the standard fashion with a biopsy forceps or snare and sent for histopathological evaluation. Each polyp will be sent in a separate jar and labeled accordingly. The bowel preparation will be evaluated and graded according to previously reported criteria (24): excellent, good, fair, and inadequate. Patients with inadequate bowel preparation will be excluded. Complications including gastrointestinal bleeding (requiring intervention) and perforation will be recorded.
Outcomes:
The predicted histology of polyps based on the confocal images and videos and the correlation with actual histology for accuracy of prediction will be the primary outcome. Secondary outcome will be the inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps (by kappa statistics).
- Conditions
- Colon Polyps, Adenomatous Polyps, Colon Cancer
- Being tested
- Confocal laser endomicroscopy (CLE)
- Keywords
- Confocal laser endomicroscope, Adenomatous polyps, Colonoscopy
- Medical subject headings
- Colonic Polyps, Adenomatous Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopy (CLE)Device
Also called Probe-based Confocal Laser Endomicroscopy (pCLE), Confocal miniprobe
Confocal laser endomicroscopy (CLE) is another novel imaging tool for enabling histopathologic diagnosis in vivo during endoscopy. Specially designed confocal endoscopes have the confocal laser microscope integrated to the distal tip of the conventional endoscope. This provide images at a cellular level that have been shown to have a high sensitivity, specificity and accuracy
| Study group | Role | What they receive |
|---|---|---|
| Confocal Laser Endomicroscopy Arm | Other | Confocal laser endomicroscopy (CLE) is another novel imaging tool for enabling histopathologic diagnosis in vivo during endoscopy. Specially designed confocal endoscopes have the confocal laser microscope integrated to the distal tip of the conventional endoscope. This provide images at a cellular level that have been shown to have a high sensitivity, specificity and accuracy. Receives: Device: Confocal laser endomicroscopy (CLE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predicted histology of polyps based on the confocal images and videos
The predicted histology of polyps based on the confocal images and videos and the correlation with actual histology for accuracy of prediction will be the primary outcome.
Measured: 2 years
Secondary outcomes (1)
The inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps
the inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps (by kappa statistics).
Measured: 2 yaers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Responsible party
- Principal investigator, Amit Rastogi, Midwest Biomedical Research
- Investigators
- Amit Rastogi, MBBS, Principal investigator, Kansas City Veterans Affairs Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214031
- Sponsor's protocol ID
- AR0005
- Status last verified
- Apr 2012
- First submitted
- 1 Oct 2010
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Evaluating Colon Polyp Histology With in Vivo Probe Based Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT01214031
- Acronym / sponsor ID
- AR0005
- Conditions
- Colon Polyps, Adenomatous Polyps, Colon Cancer
- Keywords
- Confocal laser endomicroscope, Adenomatous polyps, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chromoendoscopy (that involves spraying of dyes over the colonic mucosa) combined with magnification has been utilized for polyp histology identification. Pit patterns on the surface of polyps described by Kudo et al have been shown to have a high diagnostic accuracy in differentiating the polyp types (18, 19). NBI, that is also referred to as "electronic chromoendoscopy" is another technique that has been evaluated for polyp histology identification by highlighting the superficial mucosal and vascular architecture (15, 20, 21). pCLE is another novel addition to the technologies aiming to accomplish in vivo histologic diagnosis with a high degree of accuracy. The pCLE system has three major components (Mauna Kea Technologies, Paris, France). The first is the confocal miniprobe made of approximately thirty thousand optical fibers bundled together and terminated by a distal microsystem. The images obtained have a lateral resolution of 1µm, an axial resolution of 10 µm and a maximum field of view of 240 µm. The depth of observation is from 55 to 65 µm. The miniprobe tip diameter is 2.5 mm and can be passed through the accessory channel of any standard endoscope. The second is the laser scanning unit (excitation wavelength - 488 nm) that combines the functions of laser light illumination and rapid laser scanning, enabling a frame rate up to 12 images per second and signal detection. The third is the control and acquisition software for real time image reconstruction, immediate sequences display and post-procedure analysis and editing tools. Once an area of interest (e.g. a polyp) is identified, 5 ml of 10% fluorescein sodium is injected intravenously; the confocal probe is passed through the accessory channel of the endoscope and placed against the lesion to obtain several high-quality images and video sequences. In a study by Buchner et al from the Mayo Clinic, Jacksonville, (22) this system was used to evaluate confocal images of 37 polyps from 25 patients in a blinded fashion without the knowledge of their histologic diagnosis or endoscopic appearance. The investigators developed the following criteria that were suggestive of neoplastic polyps: villiform pattern, nuclear characteristics - oval/irregular nuclear shape and increased number of nuclei. These features had a sensitivity of 82.6%, specificity of 92.9% and accuracy of 86.5% for the characterization of neoplastic polyps. Similarly, Meining et al (23) have also evaluated criteria for differentiating neoplastic from benign lesions in the colon with encouraging results.
The investigators hypothesize that pCLE will have a high rate for accurate characterization of polyp histology real time during colonoscopy
Detailed description
This study will be conducted at the Kansas City VA Medical Center, Kansas City, MO. The investigators have the pCLE system that the investigators are currently using in a multicenter study evaluating patients with Barrett's esophagus. Patients referred for screening and/or surveillance colonoscopy will be prospectively enrolled in this study. Inclusion criteria - referral for screening and/or surveillance colonoscopy and the ability to provide informed consent. Exclusion criteria: prior surgical resection of any portion of colon, prior history of colon cancer, history of inflammatory bowel disease, use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure, poor general condition or any other reason to avoid prolonged procedure time, history of polyposis syndrome or HNPCC, inability to give informed consent, inadequate bowel preparation, allergy to fluorescein, pregnancy, and renal insufficiency. Moderate sedation for the procedure will be administered in a standard fashion with intravenous midazolam, meperidine or fentanyl. This will be a single arm study with all procedures being performed with a standard white light colonoscope (CF - H180AL, Olympus America). After cecal intubation, the colonic mucosa will be carefully visualized during withdrawal under high-definition white light and if a polyp is detected, its characteristics will be documented: size, location, and morphology [Polypoid (sessile, pedunculated) or Non-polypoid: (superficial elevated, completely flat, depressed)]. Then 5ml of 10% fluorescein sodium will be injected intravenously. Following this the pCLE probe will be passed through the biopsy channel of the colonoscope and placed on the polyp to obtain confocal images and video sequences. During the initial phase unblinded comparisons of the confocal images and videos with the polyp histology (20 adenomas, 20 hyperplastic) will be performed in order to evaluate the criteria described by the Mayo Jacksonville group (22) that differentiate between neoplastic and non neoplastic polyps. Following this initial phase, these criteria will be applied in a prospective manner to predict polyp histology (100 polyps) real time during the procedure prior to their removal. Multiple confocal images and videos of each polyp will be saved with appropriate labeling. Pathologists will be blinded to the endoscopic and pCLE findings of the polyps. Polyp size will be assessed by comparing with sheath of a polypectomy snare or open span of a biopsy forceps. Photo documentation of the polyps will be performed. Polyps will then be removed in the standard fashion with a biopsy forceps or snare and sent for histopathological evaluation. Each polyp will be sent in a separate jar and labeled accordingly. The bowel preparation will be evaluated and graded according to previously reported criteria (24): excellent, good, fair, and inadequate. Patients with inadequate bowel preparation will be excluded. Complications including gastrointestinal bleeding (requiring intervention) and perforation will be recorded.
Outcomes:
The predicted histology of polyps based on the confocal images and videos and the correlation with actual histology for accuracy of prediction will be the primary outcome. Secondary outcome will be the inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps (by kappa statistics).
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confocal Laser Endomicroscopy Arm | Other | Device: Confocal laser endomicroscopy (CLE)Confocal laser endomicroscopy (CLE) is another novel imaging tool for enabling histopathologic diagnosis in vivo during endoscopy. Specially designed confocal endoscopes have the confocal laser microscope integrated to the distal tip of the conventional endoscope. This provide images at a cellular level that have been shown to have a high sensitivity, specificity and accuracy. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- referral for screening and/or surveillance colonoscopy and the ability to provide informed consent.
Key exclusion criteria (1 listed)
- prior surgical resection of any portion of colon, prior history of colon cancer, history of inflammatory bowel disease, use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure, poor general condition or any other reason to avoid prolonged procedure time, history of polyposis syndrome or HNPCC, inability to give informed consent, inadequate bowel preparation, allergy to fluorescein, pregnancy, and renal insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confocal laser endomicroscopy (CLE)Also: Probe-based Confocal Laser Endomicroscopy (pCLE), Confocal miniprobeConfocal laser endomicroscopy (CLE) is another novel imaging tool for enabling histopathologic diagnosis in vivo during endoscopy. Specially designed confocal endoscopes have the confocal laser microscope integrated to the distal tip of the conventional endoscope. This provide images at a cellular level that have been shown to have a high sensitivity, specificity and accuracy | Device | Confocal Laser Endomicroscopy Arm |
Primary outcome
The predicted histology of polyps based on the confocal images and videos
Time frame: 2 years
The predicted histology of polyps based on the confocal images and videos and the correlation with actual histology for accuracy of prediction will be the primary outcome.
1 secondary outcome
The inter-observer variability in polyp histology prediction based on the confocal images and videos of polyps
Time frame: 2 yaers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Rastogi, MBBS principal investigator
Kansas City Veterans Affairs Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal laser endomicroscopy (CLE) in people with Colon Polyps and Adenomatous Polyps, run by Midwest Biomedical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sydney S Johnson, MBBS (816-861-4700 ext. 56428, sydney.johnson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The predicted histology of polyps based on the confocal images and videos (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2012.