Completed

High Definition Endoscopy Versus Virtual Chromoendoscopy In The Detection Of Colonic Polyps In HNPCC

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What is being tested

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

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

Other
Who is being recruted

Colonic Diseases+14

+ Digestive System Diseases

+ Digestive System Neoplasms

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: November 2010
See protocol details

Summary

Principal SponsorUniversitaire Ziekenhuizen KU Leuven
Last updated: July 26, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversitaire Ziekenhuizen KU Leuven
Last updated: July 26, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Colonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsMetabolic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryNutritional and Metabolic DiseasesColorectal NeoplasmsGenetic Diseases, InbornDNA Repair-Deficiency DisordersColorectal Neoplasms, Hereditary Nonpolyposis

Criteria

4 inclusion criteria required to participate
>= 18 years

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

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

Proven mutations in the mismatch repair genes : MLH1, MSH2, MSH6, PSM1 en PSM2

4 exclusion criteria prevent from participating
History of colectomy with less than 50 cm residual colon in place

Inflammatory bowel disease or primary sclerosing cholangitis

Insufficient bowel preparation defined as a Boston Bowel preparation Scale (BBPS) of <= 5

Known colorectal tumor or polyp on referral

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

UZ Leuven

Leuven, BelgiumOpen UZ Leuven in Google Maps
CompletedOne Study Center