Ulcerative Colitis Clinical Trial
Official title:
High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)
Verified date | December 2023 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy. This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.
Status | Enrolling by invitation |
Enrollment | 500 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patient age =18yr old 2. History of UC or colonic Crohn's disease or unclassified colitis patients with or without colonic adenoma history 3. Duration of = eight years since diagnosis, or any duration with a diagnosis of primary sclerosing cholangitis 4. Mucosal lesion involves = 1/3 of the colon Exclusion Criteria: 1. History of colorectal cancer 2. History of total colectomy 3. Prior colonoscopy within the last 6 months 4. Allergy to dye spray 5. Poor bowel preparation 6. Unable to provide informed consent 7. Severe inflammation preventing visualization of the mucosa during the procedure. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy | Immediately after the procedure | ||
Secondary | Detection rate of Adenoma in both groups. | Immediately after the procedure | ||
Secondary | Detection rate of high-grade dysplasia in both groups. | Immediately after the procedure | ||
Secondary | Numbers of detected adenomas per patient. | Immediately after the procedure | ||
Secondary | Difference in withdrawal time to perform the procedure in both groups. | Immediately after the procedure | ||
Secondary | Difference in adverse event, mild (e.g.; nausea, vomiting, or abdominal pain that necessitate phone call from the patient to the provider, or sever (e.g.; GI bleeding, perforation, hospitalization after the procedure) for each arm. | Within one week from the procedure date | ||
Secondary | Number of targeted chromoendoscopies | Immediately after the procedure | ||
Secondary | Appropriateness of reported follow up recommendations per standard guideline recommendations | Immediately after the procedure |
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