Clinical trial · Interventional
I-Scan For Colon Polyp Detection In HNPCC
High Definition Endoscopy Versus Virtual Chromoendoscopy In The Detection Of Colonic Polyps In HNPCC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hereditary non-polyposis colon carcinoma (HNPCC or Lynch-Syndrome) is a rare cause of colorectal cancer caused by a gene defect in the so -called mismatch repair genes. Patients can present at young age with colorectal cancer and polyps can develop faster to malignant lesions in comparison to classical sporadic adenomas. New advanced imaging modalities with high definition images and virtual chromoendoscopy have a theoretical advantage to improve detection and to increase polyp detection. In patients with HNPCC polyp detection has been shown to be increased by classical chromo-endoscopy and by high definition endoscopy with narrow band imaging (NBI) (a virtual chromo-endoscopy modality activated by a button on the endoscope), in comparison to white light endoscopy. However, in these back-to-back studies there was no randomization for the order of imaging modality. It is therefore not clear whether really the image enhancement adds to increased polyp detection or if this is achieved by a second inspection of the mucosa. In this trial the investigators want to assess the real additional value of virtual chromo-endoscopy for polyp detection in patients with the Lynch syndrome. The investigators will use the high definition pentax system and will compare white light endoscopy to i-scan, the incorporated virtual chromo-endoscopy mode in this system.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hereditary Non-polyposis Colon Carcinoma | — | UNRESOLVED | — |
| HNPCC | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The use of I-scan in the detection of polyps in HNPCC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- I-scan first group
- description
- 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.
- interventionNames
- Other: The use of I-scan in the detection of polyps in HNPCC
- type
- ACTIVE_COMPARATOR
- label
- White light first group
- description
- 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.
- interventionNames
- Other: The use of I-scan in the detection of polyps in HNPCC
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDQuehenberger 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. PMID 15937084
- BACKGROUNDHoffman 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. PMID 20803419
- BACKGROUNDHuneburg 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. PMID 19340735
- BACKGROUNDEast 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. PMID 17682000
- BACKGROUNDLecomte 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. PMID 16234028
- DERIVEDBisschops 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. PMID 28107763