I-Scan For Colon Polyp Detection In HNPCC

NCT01823471 | Completed

• 1 other identifier: S52579
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hereditary Non-polyposis Colon Carcinoma; HNPCC; Lynch Syndrome

Keywords

HNPCC; Hereditary non-polyposis colon carcinoma; Lynch syndrome; i-scan; virtual chromo-endoscopy; chromo-endoscopy; high definition endoscopy; polyp detection; adenoma detection; adenoma miss rate

Outcome Measures

Primary Outcomes (1)

• 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.

  Primary endpoint is assessed after completion of the trial and inclusion of 60 patients

Secondary Outcomes (1)

• The difference in overall adenoma detection between HD-WLE and i-scan

  The endpoint will be assessed after completion of the study and inclusion of 60 patients

Other Outcomes (5)

• The difference in overall adenoma detection between the first and second inspection round

  The endpoint will be assessed at the end of the study after inclusion of 60 patients

• The difference in total number of polyps between HD-WLE and i-scan expressed as the miss rate for polyps for each technique.

  The endpoint will be assessed at the end of the study after inclusion of 60 patients

• The difference in non-polypoid or flat adenomas and lesions between HD-WLE and i-scan and between the first and second inspection round.

  The endpoint will be assessed at the end of the study after inclusion of 60 patients

Study Arms (2)

I-scan first group

EXPERIMENTAL

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.

Other: The use of I-scan in the detection of polyps in HNPCC

White light first group

ACTIVE COMPARATOR

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.

Other: The use of I-scan in the detection of polyps in HNPCC

Interventions

The use of I-scan in the detection of polyps in HNPCC OTHER

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.

I-scan first group; White light first group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (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.

  PMID: 15937084 BACKGROUND

• 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.

  PMID: 20803419 BACKGROUND

• 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.

  PMID: 19340735 BACKGROUND

• 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.

  PMID: 17682000 BACKGROUND

• 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.

  PMID: 16234028 BACKGROUND

• 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.

  PMID: 28107763 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Raf Bisschops, MD PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 4, 2013
• Study Start: November 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 26, 2017

Record last verified: 2010-09

Locations

BE (1)