- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01823471
I-Scan For Colon Polyp Detection In HNPCC
High Definition Endoscopy Versus Virtual Chromoendoscopy In The Detection Of Colonic Polyps In HNPCC
Study Overview
Status
Intervention / Treatment
Detailed Description
Hereditary non-polyposis colon carcinoma (HNPCC) or the Lynch syndrome is a rare cause of colorectal cancer caused by a defect in mismatch repair genes. Because of this, colorectal cancer does not develop according to the classical adenoma-carcinoma sequence, resulting in faster progression to malignant lesions. As a results patients typically present at a younger age with colorectal cancer or associated cancers such as endometrium or ovarian cancer. The risk for cancer in patients with the Lynch syndrome has been estimated to be 60-90% for colon cancer presenting at a mean age of 44 years . Colonoscopy is considered the gold standard for polyp detection. However the polyp miss rate has been reported to be 2% for larger adenomas (< 10mm) , 13% for lesions between 5 and 10 mm and up to 26% for small lesions (1-5 mm). Between 2 to 6 percent of carcinomas can be missed , resulting interval cancers. Typically, in HNPCC small colorectal lesions can already harbor cancer or high grade dysplasia, making early detection of small lesions even more clinically relevant than in an average risk population.
New endoscopic imaging systems that are currently available have a high definition video signal and have an incorporated feature of virtual chromoendoscopy. High definition endoscopy is becoming the new gold standard in endoscopy, since it is available in all new types of commercially available endoscopes. The use of high definition endoscopy may lead to improved recognition of subtle and flat lesions. Furthermore, the use of filters techniques accentuates superficial changes in the mucosal architecture and helps to characterize polyps. I-scan is a postprocessing filter incorporated in the high definition processor (EPKi) of the new Pentax endoscopes. The techniques highlights changes in surface and vessel architecture through 3 different modifications (so called surface enhancement, tone enhancement and contrast enhancement). In a randomized trial in patients with a positive feces occult blood test it has been shown that the system detects significantly more polyps than standard resolution white light.
Current literature suggests that classical chromoendoscopy with indigocarmine (Huneberg, lecomte) or narrow-band imaging (NBI) increases the detection of polyps in HNPCC patients. Although all of these studies had a cross-over design, randomization for the imaging modality was either not possible (in case of chromoendoscopy) or not applied (in case of NBI). So it is not clear whether more polyps are detected by advanced imaging techniques, or simply by a second inspection of the colon.
The aim of this study was to assess the additional value of i-scan in polyp detection in HNPCC patients in comparison to high definition white light endoscopy (HD-WLE) in a randomized controlled cross-over trial. The investigators also wanted to investigate the effect of a second inspection round on polyp detection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Leuven, Belgium, 3000
- UZ Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 18 years
- Clinical diagnosis of HNPCC according to the Amsterdam II criteria : 3 or more family members with colorectal, ovarian or endometrium cancer; 2 or more affected generations; at least one first degree relative should be affected; at least one relative with a diagnosis before the age of 50.
- Clinical diagnosis according to the modified Bethesda criteria : colon cancer before the age of 50; synchronic or metachronic colorectal of other HNPCC related tumors at any age; Colon cancer with high microsatellite instability on histology before the age of 60; Colon cancer in a patient with one or more first degree relatives with a HNPCC related tumor, and one of these being diagnosed before the age of 50; Colon cancer in a patient with 2 or more first degree relatives with HNPCC related tumors regardless the age at diagnosis
- Proven mutations in the mismatch repair genes : MLH1, MSH2, MSH6, PSM1 en PSM2
Exclusion Criteria:
- History of colectomy with less than 50 cm residual colon in place
- Known colorectal tumor or polyp on referral
- Inflammatory bowel disease or primary sclerosing cholangitis
- Insufficient bowel preparation defined as a Boston Bowel preparation Scale (BBPS) of ≤ 5.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: I-scan first group
After the caecum is reached patients will be first examined with high definition i-scan endoscopy.
Each colonic segment will be investigated in a back to back fashion, during the second pass white light will be used.
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Prior the colonoscopy patients will be randomized to white light first or i-scan first.
After the caecum is reached patients will be first examined according to the randomization.
Each colonic segment will be investigated in a back to back fashion, during the second pass the other modality will be used.
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Active Comparator: White light first group
After the caecum is reached patients will be first examined with high definition white light endoscopy.
Each colonic segment will be investigated in a back to back fashion, during the second pass i-scan will be used.
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Prior the colonoscopy patients will be randomized to white light first or i-scan first.
After the caecum is reached patients will be first examined according to the randomization.
Each colonic segment will be investigated in a back to back fashion, during the second pass the other modality will be used.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint of the study was the difference in adenoma detection between HD-WLE and i-scan, expressed as the miss rate for polyps for each technique.
Time Frame: Primary endpoint is assessed after completion of the trial and inclusion of 60 patients
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Primary endpoint is assessed after completion of the trial and inclusion of 60 patients
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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The difference in overall adenoma detection between HD-WLE and i-scan
Time Frame: The endpoint will be assessed after completion of the study and inclusion of 60 patients
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The endpoint will be assessed after completion of the study and inclusion of 60 patients
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in overall adenoma detection between the first and second inspection round
Time Frame: The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The difference in total number of polyps between HD-WLE and i-scan expressed as the miss rate for polyps for each technique.
Time Frame: The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The difference in non-polypoid or flat adenomas and lesions between HD-WLE and i-scan and between the first and second inspection round.
Time Frame: The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The difference in diminutive lesions (<5mm) lesions between HD-WLE and i-scan and between the first and second inspection round.
Time Frame: The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The difference in advanced adenomas between HD-WLE and i-scan and between the first and second inspection round.
Time Frame: The endpoint will be assessed at the end of the study after inclusion of 60 patients
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The endpoint will be assessed at the end of the study after inclusion of 60 patients
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Collaborators and Investigators
Publications and helpful links
General Publications
- Huneburg R, Lammert F, Rabe C, Rahner N, Kahl P, Buttner R, Propping P, Sauerbruch T, Lamberti C. Chromocolonoscopy detects more adenomas than white light colonoscopy or narrow band imaging colonoscopy in hereditary nonpolyposis colorectal cancer screening. Endoscopy. 2009 Apr;41(4):316-22. doi: 10.1055/s-0028-1119628. Epub 2009 Apr 1.
- East JE, Suzuki N, Stavrinidis M, Guenther T, Thomas HJ, Saunders BP. Narrow band imaging for colonoscopic surveillance in hereditary non-polyposis colorectal cancer. Gut. 2008 Jan;57(1):65-70. doi: 10.1136/gut.2007.128926. Epub 2007 Aug 6.
- Quehenberger F, Vasen HF, van Houwelingen HC. Risk of colorectal and endometrial cancer for carriers of mutations of the hMLH1 and hMSH2 gene: correction for ascertainment. J Med Genet. 2005 Jun;42(6):491-6. doi: 10.1136/jmg.2004.024299.
- Hoffman A, Sar F, Goetz M, Tresch A, Mudter J, Biesterfeld S, Galle PR, Neurath MF, Kiesslich R. High definition colonoscopy combined with i-Scan is superior in the detection of colorectal neoplasias compared with standard video colonoscopy: a prospective randomized controlled trial. Endoscopy. 2010 Oct;42(10):827-33. doi: 10.1055/s-0030-1255713. Epub 2010 Aug 27.
- Lecomte T, Cellier C, Meatchi T, Barbier JP, Cugnenc PH, Jian R, Laurent-Puig P, Landi B. Chromoendoscopic colonoscopy for detecting preneoplastic lesions in hereditary nonpolyposis colorectal cancer syndrome. Clin Gastroenterol Hepatol. 2005 Sep;3(9):897-902. doi: 10.1016/s1542-3565(05)00403-9.
- Bisschops R, Tejpar S, Willekens H, De Hertogh G, Van Cutsem E. Virtual chromoendoscopy (I-SCAN) detects more polyps in patients with Lynch syndrome: a randomized controlled crossover trial. Endoscopy. 2017 Apr;49(4):342-350. doi: 10.1055/s-0042-121005. Epub 2017 Jan 20.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Metabolic Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Neoplastic Syndromes, Hereditary
- DNA Repair-Deficiency Disorders
- Colorectal Neoplasms, Hereditary Nonpolyposis
Other Study ID Numbers
- S52579
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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