Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | March 2006 |
| End Date: | August 2010 |
A Blinded Comparison of Conventional Colonoscopy to Endoscopic AFI and NBI for Dysplasia Detection in Patients With Ulcerative Colitis and Sclerosing Cholangitis or Known Colorectal Dysplasia or Cancer- A Pilot Clinical Study
This study is being done to:
To attempt to increase the detection of precancerous colon tissue in patients with chronic
ulcerative colitis and primary sclerosing cholangitis;
To determine if an investigational scope that can look at the lining of the colon in
different ways will help the doctor identify abnormal tissue in patients with chronic
ulcerative colitis and concurrent primary sclerosing cholangitis; and
To determine if this investigational scope can accurately detect precancerous or cancerous
tissue in patients with chronic ulcerative colitis that are known to have had cancerous or
precancerous tissue in the past.
To attempt to increase the detection of precancerous colon tissue in patients with chronic
ulcerative colitis and primary sclerosing cholangitis;
To determine if an investigational scope that can look at the lining of the colon in
different ways will help the doctor identify abnormal tissue in patients with chronic
ulcerative colitis and concurrent primary sclerosing cholangitis; and
To determine if this investigational scope can accurately detect precancerous or cancerous
tissue in patients with chronic ulcerative colitis that are known to have had cancerous or
precancerous tissue in the past.
Patients with concurrent chronic ulcerative colitis and primary sclerosing cholangitis or
patients with chronic ulcerative colitis and known colorectal dysplasia or cancer,
presenting for surveillance colonoscopy will be recruited. After giving informed consent
patients will then undergo colonoscopy in a segmental fashion. Colonoscopy with white light
will be performed to the cecum and examination will be performed on withdrawal. First
conventional white light will be used to examine the cecum and ascending colon and random
biopsies will be obtained. All endoscopically apparent lesions will be biopsied separately.
Immediately following will be examination of that segment of cecum and ascending colon under
AFI first, then NBI with targeted biopsies of suspicious areas being taken. The AFI and NBI
modality will be achieved by simply flipping a switch.. If necessary, washing of oozing
blood from random biopsy sites will be performed., The remainder of the colon will be
assessed in like fashion: transverse, descending and rectosigmoid. Because high definition
endoscopy is the default modality, this will be in use throughout the procedure.
All lesions detected will be documented and biopsied for a maximum of four biopsies per
suspicious lesion. Note will be taken of which modality resulted in visualization of the
lesion. Data on the factors under study will be collected: i) disease type (CUC + PSC or CUC
with known dysplasia), ii) Age, iii) Sex, iv) length of time with disease, v) extent of
disease, vi) the interaction between iv and v will be collected. In addition, dysplasia
yes/no will be established after biopsy histology is established and the modality under
which abnormalities were observed will also be recorded.
patients with chronic ulcerative colitis and known colorectal dysplasia or cancer,
presenting for surveillance colonoscopy will be recruited. After giving informed consent
patients will then undergo colonoscopy in a segmental fashion. Colonoscopy with white light
will be performed to the cecum and examination will be performed on withdrawal. First
conventional white light will be used to examine the cecum and ascending colon and random
biopsies will be obtained. All endoscopically apparent lesions will be biopsied separately.
Immediately following will be examination of that segment of cecum and ascending colon under
AFI first, then NBI with targeted biopsies of suspicious areas being taken. The AFI and NBI
modality will be achieved by simply flipping a switch.. If necessary, washing of oozing
blood from random biopsy sites will be performed., The remainder of the colon will be
assessed in like fashion: transverse, descending and rectosigmoid. Because high definition
endoscopy is the default modality, this will be in use throughout the procedure.
All lesions detected will be documented and biopsied for a maximum of four biopsies per
suspicious lesion. Note will be taken of which modality resulted in visualization of the
lesion. Data on the factors under study will be collected: i) disease type (CUC + PSC or CUC
with known dysplasia), ii) Age, iii) Sex, iv) length of time with disease, v) extent of
disease, vi) the interaction between iv and v will be collected. In addition, dysplasia
yes/no will be established after biopsy histology is established and the modality under
which abnormalities were observed will also be recorded.
Inclusion Criteria:
- patients requiring a clinically indicated surveillance colonoscopy
- able to give informed written consent
- history of chronic ulcerative colitis and colonic dysplasia/or cancer or primary
sclerosing cholangitis
Exclusion Criteria:
- patients with known colonic obstruction
- INR ./= 2.5 or thrombocytopenia ,50,000
- patients with clinically important cardiopulmonary disease who are unable to safely
undergo prolonged conscious sedation
- pregnancy
- symptomatic coronary artery disease
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