Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Colitis

Colitis, Ulcerative

Ulcer

Cholangitis

Cholangitis, Sclerosing

Gastroenteritis

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Bile Duct Diseases

Biliary Tract Diseases

Primary Sclerosing Cholangitis

Patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis.

Patients with chronic ulcerative colitis and known dysplasia or cancer.

Christopher J Gostout, MD

This study is being done to:

To attempt to increase the detection of precancerous colon tissue in patients with chronic ulcerative colitis and primary sclerosing cholangitis;

To determine if an investigational scope that can look at the lining of the colon in different ways will help the doctor identify abnormal tissue in patients with chronic ulcerative colitis and concurrent primary sclerosing cholangitis; and

To determine if this investigational scope can accurately detect precancerous or cancerous tissue in patients with chronic ulcerative colitis that are known to have had cancerous or precancerous tissue in the past.

Patients with concurrent chronic ulcerative colitis and primary sclerosing cholangitis or patients with chronic ulcerative colitis and known colorectal dysplasia or cancer, presenting for surveillance colonoscopy will be recruited. After giving informed consent patients will then undergo colonoscopy in a segmental fashion. Colonoscopy with white light will be performed to the cecum and examination will be performed on withdrawal. First conventional white light will be used to examine the cecum and ascending colon and random biopsies will be obtained. All endoscopically apparent lesions will be biopsied separately. Immediately following will be examination of that segment of cecum and ascending colon under AFI first, then NBI with targeted biopsies of suspicious areas being taken. The AFI and NBI modality will be achieved by simply flipping a switch.. If necessary, washing of oozing blood from random biopsy sites will be performed., The remainder of the colon will be assessed in like fashion: transverse, descending and rectosigmoid. Because high definition endoscopy is the default modality, this will be in use throughout the procedure.

All lesions detected will be documented and biopsied for a maximum of four biopsies per suspicious lesion. Note will be taken of which modality resulted in visualization of the lesion. Data on the factors under study will be collected: i) disease type (CUC + PSC or CUC with known dysplasia), ii) Age, iii) Sex, iv) length of time with disease, v) extent of disease, vi) the interaction between iv and v will be collected. In addition, dysplasia yes/no will be established after biopsy histology is established and the modality under which abnormalities were observed will also be recorded.

Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis

A Blinded Comparison of Conventional Colonoscopy to Endoscopic AFI and NBI for Dysplasia Detection in Patients With Ulcerative Colitis and Sclerosing Cholangitis or Known Colorectal Dysplasia or Cancer- A Pilot Clinical Study

Mayo Clinic

Neoplasms

Adenoma

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

I-Scan 1 modality will be used by the endoscopist for the entire procedure

High definition white light modality will be used by the endoscopist for the entire procedure

I-Scan 2 modality will be used by th endoscopist through out the procedure

I-Scan 1 has contrast enhancement (CE)and surface enhancement (SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail.CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.

I-Scan 1

HD Colon

I-Scan 2 has contrast enhancement (CE), surface enhancement (SE) and tone enhancement (TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail.CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.TE provides a uniform colour image and is intended for detailed inspection of distinct lesions.

I-Scan 2

Robert Hilsden, MD

The purpose of the study is to assess whether the use of I-scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.

Primary Outcome:

To estimate the mean number of adenomas per colonoscopy for both high definition white light colonoscopy and I-scan enhanced colonoscopy

Secondary Outcomes:

1. To estimate the recruitment rate
2. Number of adenomas detected in the right colon during the second look

Colorectal Cancer is the third most common cause of cancer in Canada with an estimated lifetime risk of developing the disease of 6-7%. Each year there are approximately 21,000 new cases and 9,100 deaths attributable to this disease. Colonoscopy is one of several methods recommended for CRC screening by current guidelines. While colonoscopy is the most invasive, it offers high diagnostic accuracy and ability for therapy (biopsy and removal of adenomas) compared to other modalities. The emerging evidence regarding missed neoplastic lesions with colonoscopy has resulted in quality initiatives designed to improve colonoscopy performance. I-Scan (Pentax, Montvale, NJ) is a new method that uses post processing computer algorithms to revise the standard white light to highlight pit patterns and vascular surface patterns.The relevant I-scan settings in the colon are I-scan 1 and I-scan 2. The primary objective of the study is to compare the adenoma detection rate in the right colon using High-definition white light colonoscopy versus I-scan enhanced colonoscopy.

All patients referred for a screening colonoscopy at Forzani and MacPhail Colon Cancer Centre will be considered for enrollment.All eligible patients that are not part of another research study will be approached for enrollment into the study. During the pre-assessment at the clinic a study assistant will contact all the eligible patients to describe the study and provide an "Invitation to participate in a Research study" form. The study assistant will obtain a final consent if they agree. Those not interested will simply receive the Centre's standard protocol. There will be no coercion of any sort. Following Informed Consent, treatment allocation through computer generated randomization will be revealed. Patients will be allocated to one of the three study arms (HD Colon, I-scan 1 and I-Scan 2). Patients will receive a standard bowel preparation: Split dose Polyethylene Glycol (PEG) (2L at noon + 2L at 8 PM the day before) for morning procedures or (2L at 8Pm the day before and 2L at five hours before the procedure on the day of colonoscopy) for afternoon procedure. certified gastroenterologists will perform all of the procedures with the assistance of a nurse. The planned "second look" of the right colon will involve withdrawing from the Cecum to Hepatic flexure, then re-inserting to Cecum and finally withdrawing through the entire colon. The physician performing the procedure will then fill a "Colonoscopy Report Form" including the number of polyps detected, size, shape, polypectomy method and cleanliness of the bowel.

I-Scan Versus High-definition White Light

A Randomized Controlled Trial Comparing High-definition White Light Colonoscopy to I-Scan Enhanced Colonoscopy for Adenoma Detection in a Population at Increased Risk of Colorectal Cancer. (A Pilot Study)

The "Colonoscopy Report Form" completed by the Physician helps to assess the number of polyps and a endoscopic description (location, size, shape) of these lesions including. Following formal review by the pathologist the polyp classification (e.g. whether it is an adenoma) is determined.

The planned "Second Look" of the right colon will involve withdrawing from the cecum to hepatic flexure, then re-inserting to the cecum and finally withdrawing through the entire colon. This is to determine if a "Second Look" in the right colon increases the mean number of adenomas detected compared with a single inspection irrespective of the imaging modality.

Recruitment rates will be reported as follows:

1. No. of patients given the study invitation letter
2. No. of patients who return the form as interested
3. No. of patients who provided informed consent
4. No. of patients who complete the study protocol

University of Calgary

Associate Professor, Department of Medicine & Research Director, Colon Cancer screening Centre

High Definition White Light modality will be used by the endoscopist for the entire procedure.

I-scan 1 modality will be used by the endoscopist for the entire procedure.

I-Scan 2 modality will be used by the endoscopist through out the procedure.

I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.

I-scan 1

I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE)and Tone Enhancement(TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities. TE provides a uniform color image and is intended for detailed inspection of distinct lesions.

Dr. Steven Heitman, MD

Anitha Jambula, M.Sc, CCRP

Steven Heitman, MD, M.Sc

Rachid Mohamed, MD

Alaa Rostom, MD, M.Sc

Subrata Ghosh, MD

Dr.Robert Hilsden, MD

The purpose of this study is to assess whether the use of I-Scan during colonoscopy leads to an increased yield of adenomas in the colon among a population at increased risk for CRC.

Primary Outcome:

Adenoma Detection Rate (ADR - No. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period) in the right colon using High Definition White Light Colonoscopy Versus I-Scan enhanced Colonoscopy.

Secondary Outcomes:

* Adenoma Detection Rate (ADR) of High Definition White Light Colonoscopy Versus I-Scan colonoscopy through out the entire colon.
* Adenoma Detection Rate (ADR) in the right colon during the "Second look", irrespective of imaging modality.
* Polyp Detection Rate (PDR - No. of colonoscopies at which one or more polyps were found(regardless of the histological type) divided by the total no. of colonoscopies performed in the Same time period) for each arm of the study in Right colon and throughout the entire colon.
* Mean number of adenomas per procedure for each arm of the study in right colon and throughout the entire colon.
* Mean number of polyps per procedure for each arm of the study in right colon and throughout the entire colon.
* Number of neoplastic lesions for each arm of the study in the right colon and throughout the entire colon and number of neoplastic lesions missed on 1st pass of right colon.
* Proportion of patients with diminutive lesions (\< 5 mm) in each arm of the study
* Proportion of patients with Flat lesions (height \< 1/2 diameter) in each arm of the study
* Proportion of patients with Sessile Serrated Adenoma in each arm of the study
* Proportion of patients with invasive cancer in each arm of the study
* Presence or absence of learning effect while using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.

Colorectal Cancer is the third most common cause of cancer in Canada with an estimated lifetime risk of developing the disease of 6-7%. Each year there are approximately 21,000 new cases and 9,100 deaths attributable to this disease. Colonoscopy is one of several methods recommended for Colorectal Cancer (CRC) screening by current guidelines. While colonoscopy is the most invasive, it offers high diagnostic accuracy and ability for therapy (biopsy and removal of adenomas) compared to other modalities. The emerging evidence regarding missed neoplastic lesions with colonoscopy has resulted in quality initiatives designed to improve colonoscopy performance. I-Scan (Pentax, Montvale, NJ) is a new method that uses post processing computer algorithms to revise the standard white light to highlight pit patterns and vascular surface patterns.The relevant I-scan settings in the colon are I-scan 1 and I-scan 2. The primary objective of the study is to compare the adenoma detection rate in the right colon using High-definition white light colonoscopy versus I-scan enhanced colonoscopy.

All patients referred for a screening colonoscopy at Forzani and MacPhail Colon Cancer Centre will be considered for enrollment.All eligible patients that are not part of another research study will be approached for enrollment into the study. During the pre-assessment at the clinic a study assistant will contact all the eligible patients to describe the study and provide an "Invitation to participate in a Research study" form. The study assistant will obtain a final consent if they agree. Those not interested will simply receive the Centre's standard protocol. There will be no coercion of any sort. Following Informed Consent, treatment allocation through computer generated randomization will be revealed. Patients will be allocated to one of the three study arms (HD Colon, I-scan 1 and I-Scan 2). Patients will receive a standard bowel preparation: Split dose Polyethylene Glycol (PEG) (2L at noon + 2L at 8 PM the day before) for morning procedures or (2L at 8Pm the day before and 2L at five hours before the procedure on the day of colonoscopy) for afternoon procedure. certified gastroenterologists will perform all of the procedures with the assistance of a nurse. The planned "second look" of the right colon will involve withdrawing from the Cecum to Hepatic flexure, then re-inserting to Cecum and finally withdrawing through the entire colon. The physician performing the procedure will then fill a "Colonoscopy Report Form" including the number of polyps detected, size, shape, polypectomy method and cleanliness of the bowel.

The investigators did a pilot study with 150 subjects to check the mean no.of adenomas per colonoscopy, no.of adenomas detected in the right colon during the second look and to estimate the recruitment rate. Based on those results the investigators started this study with a large sample size. The investigators are planning to do an interim analysis after recruiting 450 subjects (30% of total enrollment). The results of the analysis will determine whether the investigators complete recruitment of the initially approved sample size of 1500 subjects.

I-Scan Vs High Definition White Light (Main Study)

A Randomized Controlled Trial Comparing High-definition White Light Colonoscopy to I-scan Enhanced Colonoscopy for Adenoma Detection in a Population at Increased Risk of Colorectal Cancer (Main Study)

To determine if there is a learning effect when using this technology given that use of I-Scan may train the human eye to better identify adenomas even without image enhancement.

Adenoma Detection Rate is defined as no. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period. The "Colonoscopy Report Form" filled by the Endoscopist helps to assess the number of polyps including an endoscopic description (Location, Size, Shape) of these lesions. Following formal review by the pathologist the polyp classification (eg: Whether it is an adenoma) is determined.

The planned "Second Look" of the right colon will involve withdrawing from the cecum to hepatic flexure, then re-inserting to cecum and finally withdrawing through the entire colon. This is to determine if a "Second Look" in the right colon increases the ADR compared with a single inspection irrespective of imaging modality.

Adenoma Detection Rate is defined as no. of colonoscopies at which one or more histologically confirmed adenomas were found divided by the total no. of colonoscopies performed in the same time period. The "Colonoscopy Report Form' completed by the Endoscopist helps to assess the number of polyps detected and an endoscopic description (location, shape, size) of these polyps.Following formal review by the pathologist the polyp classification (Eg: wether it is an Adenoma) is determined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis	NCT00587236	Colitis, Ulcera... Cholangitis, Sc...		18 Years - 75 Years	Mayo Clinic
Compare Conventional Colonosocpy to Endoscopic AFI, NBI for Dysplasia Detection for Ulcerative Colitis & Cholangitis	NCT00587236	Colitis, Ulcera... Cholangitis, Sc...		18 Years - 75 Years	Mayo Clinic
I-Scan Versus High-definition White Light	NCT01617278	Colorectal Canc...	I-Scan 1 HD Colon I-Scan 2	18 Years - 74 Years	University of Calgary
I-Scan Vs High Definition White Light (Main Study)	NCT02016326	Colorectal Canc...	HD Colon I-scan 1 I-Scan 2	18 Years - 74 Years	University of Calgary
I-Scan Vs High Definition White Light (Main Study)	NCT02016326	Colorectal Canc...	HD Colon I-scan 1 I-Scan 2	18 Years - 74 Years	University of Calgary

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