PseudopolypNCT01557387
Real-time Diagnosis of Pseudopolyps During Colonoscopy
An observational study of Pseudopolyp and Inflammatory Bowel Disease, run by University of Miami at 2 sites in United States.
Trial summary
Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could decrease the need and expense of endoscopic biopsy for these lesions. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pseudopolyp, Inflammatory Bowel Disease
- What is being tested?
- Endoscopic techniques
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Feb 2013
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 100 patients with inflammatory bowel disease (IBD) will be enrolled in the study. They will be identified from a population of patients undergoing colonoscopy for diagnostic purposes with IBD.
Who may be able to join
- Patients equal to or over 18 years of age with a confirmed diagnosis of inflammatory bowel disease with plans for routine colonoscopic evaluation and able to provide informed consent will be included.
Who cannot join
- Patients under 18 years of age.
- Patient unwilling or unable to undergo colonoscopy with biopsies or preparation for colonoscopy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Hospital and Clinics
Miami, Florida, 33136
University of Miami Hospital
Miami, Florida, 33136
About this study
Official title: Real-time Diagnosis of Pseudopolyps During Colonoscopy Using Noninvasive Advanced Endoscopic Techniques - a Prospective Study
Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could decrease the need and expense of endoscopic biopsy for these lesions.
Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying techniques using indigo carmine which will predict diagnosis without biopsy.
Read more
100 patients with inflammatory bowel disease will be enrolled in the study. Following a standard bowel preparation, each patient will be evaluated using standard endoscopic equipment. All patients will receive a standard bowel preparation (sodium phosphate, PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be performed for indications unrelated to the present study, including evaluation of response to medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal bleeding. Polypoid lesions will be examined using four consecutive methods: (a) high definition white light, (b) narrow band imaging, (c) chromoendoscopy (high definition white light with indigo carmine dye-spraying), and (d) histologic examination following biopsy. The flat mucosa surrounding the polypoid lesions will also be examined using theses four techniques in an effort to identify dysplastic tissue associated with these polypoid growths.
High definition white light is the standard imaging modality used for colonoscopy. Narrow band imaging (blue wavelength of light) is also used routinely and is available on all current generation colonoscopes with the press of a button. Our division routinely uses chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa. The dye used will be indigo carmine.
Directed biopsy specimens will then be performed using a multibite forceps for targeted biopsies. Routine biopsies will be performed as clinically indicated. Pathology slides will be reviewed by the gastrointestinal pathologists at the University of Miami. The gastroenterologist's interpretation based on each of the three successive endoscopic methods will then be compared to the histologic evaluation with each individual lesion serving as its own control.
Read the detailed description
The colonoscopy with biopsies will be done as standard of care; additional biopsies will be taken for research purposes as detailed above. All of the imaging techniques are part of the accepted standard of care as follows: high definition white light, narrow band imaging, chromoendoscopy, and histologic examination following biopsy. Comparison of the predictive values of the imaging modalities in predicting histology from biopsy underlies the primary question of this research protocol. Cost analysis of modalities versus histology will also be performed. Time for use of the individual modalities will be recorded.
Subjects will be identified by one of the investigators during their outpatient clinic visits or while inpatient at University of Miami Hospital. Subjects who meet the inclusion/exclusion criteria and are scheduled to undergo a colonoscopy for standard of care purposes will be asked to participate in the study. Patients over 18 years of age with a confirmed diagnosis of inflammatory bowel disease with plans for routine colonoscopic evaluation and able to provide informed consent will be included.
- Conditions
- Pseudopolyp, Inflammatory Bowel Disease
- Being tested
- Endoscopic techniques
- Keywords
- Pseudopolyp, Inflammatory bowel disease
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic techniquesOther
All patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia
| Study group | Role | What they receive |
|---|---|---|
| Patients with pseudopolyps. | No treatment involved in this study. Receives: Other: Endoscopic techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis
Measured: 2 years or until 100 patients enrolled, whichever comes first
Secondary outcomes (1)
Cost of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis
Measured: 2 years or until 100 patients enrolled, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PseudopolypStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus America, Inc.
- Responsible party
- Principal investigator, Daniel A. Sussman, MD, MSPH, University of Miami
- Investigators
- Daniel A Sussman, MD, MSPH, Principal investigator, University of Miami Division of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557387
- Sponsor's protocol ID
- 20091017
- Status last verified
- Aug 2018
- First submitted
- 11 Aug 2011
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sussman DA, Barkin JA, Martin AM, Varma T, Clarke J, Quintero MA, Barkin HB, Deshpande AR, Barkin JS, Abreu MT. Development of Advanced Imaging Criteria for the Endoscopic Identification of Inflammatory Polyps. Clin Transl Gastroenterol. 2015 Nov 19;6(11):e128. doi: 10.1038/ctg.2015.51.
PubMed 26583503
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Diagnosis of Pseudopolyps During Colonoscopy Using Noninvasive Advanced Endoscopic Techniques - a Prospective Study
- ClinicalTrials.gov ID
- NCT01557387
- Acronym / sponsor ID
- 20091017
- Conditions
- Pseudopolyp, Inflammatory Bowel Disease
- Keywords
- Pseudopolyp, Inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Olympus America, Inc.
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Mar 2012 (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.
Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could decrease the need and expense of endoscopic biopsy for these lesions.
Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying techniques using indigo carmine which will predict diagnosis without biopsy.
100 patients with inflammatory bowel disease will be enrolled in the study. Following a standard bowel preparation, each patient will be evaluated using standard endoscopic equipment. All patients will receive a standard bowel preparation (sodium phosphate, PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be performed for indications unrelated to the present study, including evaluation of response to medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal bleeding. Polypoid lesions will be examined using four consecutive methods: (a) high definition white light, (b) narrow band imaging, (c) chromoendoscopy (high definition white light with indigo carmine dye-spraying), and (d) histologic examination following biopsy. The flat mucosa surrounding the polypoid lesions will also be examined using theses four techniques in an effort to identify dysplastic tissue associated with these polypoid growths.
High definition white light is the standard imaging modality used for colonoscopy. Narrow band imaging (blue wavelength of light) is also used routinely and is available on all current generation colonoscopes with the press of a button. Our division routinely uses chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa. The dye used will be indigo carmine.
Directed biopsy specimens will then be performed using a multibite forceps for targeted biopsies. Routine biopsies will be performed as clinically indicated. Pathology slides will be reviewed by the gastrointestinal pathologists at the University of Miami. The gastroenterologist's interpretation based on each of the three successive endoscopic methods will then be compared to the histologic evaluation with each individual lesion serving as its own control.
Detailed description
The colonoscopy with biopsies will be done as standard of care; additional biopsies will be taken for research purposes as detailed above. All of the imaging techniques are part of the accepted standard of care as follows: high definition white light, narrow band imaging, chromoendoscopy, and histologic examination following biopsy. Comparison of the predictive values of the imaging modalities in predicting histology from biopsy underlies the primary question of this research protocol. Cost analysis of modalities versus histology will also be performed. Time for use of the individual modalities will be recorded.
Subjects will be identified by one of the investigators during their outpatient clinic visits or while inpatient at University of Miami Hospital. Subjects who meet the inclusion/exclusion criteria and are scheduled to undergo a colonoscopy for standard of care purposes will be asked to participate in the study. Patients over 18 years of age with a confirmed diagnosis of inflammatory bowel disease with plans for routine colonoscopic evaluation and able to provide informed consent will be included.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pseudopolyps. | – | Other: Endoscopic techniquesNo treatment involved in this study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 100 patients with inflammatory bowel disease (IBD) will be enrolled in the study. They will be identified from a population of patients undergoing colonoscopy for diagnostic purposes with IBD.
Key inclusion criteria (1 listed)
- Patients equal to or over 18 years of age with a confirmed diagnosis of inflammatory bowel disease with plans for routine colonoscopic evaluation and able to provide informed consent will be included.
Key exclusion criteria (2 listed)
- Patients under 18 years of age.
- Patient unwilling or unable to undergo colonoscopy with biopsies or preparation for colonoscopy.
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 |
|---|---|---|
| Endoscopic techniquesAll patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia | Other | Patients with pseudopolyps. |
Primary outcome
Accuracy of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis
Time frame: 2 years or until 100 patients enrolled, whichever comes first
1 secondary outcome
Cost of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis
Time frame: 2 years or until 100 patients enrolled, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Derived from this study: PubMed 26583503Sussman DA, Barkin JA, Martin AM, Varma T, Clarke J, Quintero MA, Barkin HB, Deshpande AR, Barkin JS, Abreu MT. Development of Advanced Imaging Criteria for the Endoscopic Identification of Inflammatory Polyps. Clin Transl Gastroenterol. 2015 Nov 19;6(11):e128. doi: 10.1038/ctg.2015.51.
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.
Daniel A Sussman, MD, MSPH principal investigator
University of Miami Division of Gastroenterology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudopolyp and Inflammatory Bowel Disease, run by University of Miami at 2 sites 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 2 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: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis (time frame: 2 years or until 100 patients enrolled, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01557387, which also lists 1 linked publication.
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 3 Aug 2018.