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Patients with longstanding ulcerative colitis (inflammatory bowel disease, IBD) have increased risk of developing colorectal cancer (CRC) when compared with that of the general population. Therefore patients with longstanding colitis undergo regular screening colonoscopy at varied time intervals depending on their individual risk. This is thought to detect early mucosal (interior bowel lining) abnormalities, known as dysplasia, which can progress to CRC. Until recently, IBD surveillance has relied upon colonoscopy with multiple (at least 33) random biopsies of the bowel lining to detect dysplasia, but now international guidelines recommended a technique called chromoendoscopy.
Chromoendoscopy involves applying a dye, called indigo-carmine, to the bowel lining whilst performing colonoscopy which highlights more subtle abnormalities, therefore increasing dysplasia detection rate.
There is no standard international concentration of the dye spray used during chromoendoscopy. Studies have used different concentrations of indigo-carmine dye ranging from 0.1 to 0.4%. We have recently shown that 0.2% dye improves detection rates compared to high definition white light. The recent international SCENIC guidelines suggest using 0.03% indigo-carmine via a foot pump. However there are no trials comparing the two methods and no previous trials have used the 0.03%. We therefore aim to perform a randomised control trial, comparing 0.03% indigo-carmine dye versus 0.2% in detecting dysplasia in patients undergoing surveillance colonoscopy in IBD. Any lesions seen will assessed using standard endoscopic appearance but also using optical biopsy forceps to further characterise the lesion, then manage the lesion as standard guidelines. We will also take two additional rectal biopsies, which will be snap frozen in liquid nitrogen and then studied using Raman Spectroscopy, Infra Red spectroscopy and electrochemical impedance to develop optical markers to identify patients at higher risk of dysplasia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with extensive colitis | Experimental | Patients with extensive colitis, for at least 8-10 years, already on the surveillance programme or newly referred whilst attending their outpatients IBD clinic at Leeds Teaching Hospitals NHS Trust will be screened by one of the research doctors who will be performing the surveillance colonoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indigo-carmine 0.2% using a spray catheter | Procedure |
| ||
| 0.03% using a foot pump |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with at least low grade dysplasia detected by targeted biopsy using 0.2% indigo-carmine compared with 0.03% indigo-carmine. | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Venkataraman Subramanian, MBBS, MRCP, MD | Contact | venkat.subramanian@nhs.net | ||
| Richard Lord, MBChB, MRCP | Contact | richard.lord2@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Teaching Hospitals NHS Trust | Recruiting | Leeds | LS1 3HE, | United Kingdom |
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| ID | Term |
|---|---|
| D007203 | Indigo Carmine |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Procedure |
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