High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) involving the colon is a known risk for colon cancer. There are two standards-of-care colonoscopy techniques used for screening all patients who suffer from IBD for more than eight years. One method is to obtain random biopsies throughout the colon and the other is by using dye spraying chromo-colonoscopy.

This trial aims to study the difference between the two colonoscopy techniques during the era of high definition camera in detecting neoplastic lesions during screening patients with long-standing IBD.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Colitis; Indeterminate Colitis; Colon Dysplasia
• Intervention / Treatment: Device: High Definition Colonoscopy; Device: Dye Spraying Chromocolonoscopy

Detailed Description

Research Question:

Is High Definition White Light Colonoscopy (HDWLC) not inferior to Dye Spraying Chromo-colonoscopy (DSC) in detecting all neoplastic lesions during screening patients with colonic IBD for more than eight years?

Study setting: The study will be conducted at Beth Israel Deaconess Medical Center. Patients will be randomized to HDWLC with biopsies every 10 cm versus DSC.

Study population: Adult patients colonic IBD for more than eight years.

Recruitment The study team will conduct a day by day chart review for all patients with a history of inflammatory bowel disease who were scheduled for screening colonoscopy and find candidates who meet the eligibility criteria. A study team member will meet with the potential candidates during their visit to the gastroenterology procedure room before having their colonoscopy and offer them to participate in the study.

Procedures: Participants will undergo either HDWLC with biopsies every 10 cm or DSC based on the randomization. Both procedures are standard of care and are being done at BIDMC before starting this study. All the endoscopists are IBD specialists with expertise in both procedures. All physicians were given a review article and video of chromoendoscopy to further standardize practice. The clinicians who are conducting the HDWLC are allowed to do a targeted DSC if required as per hospital protocol. Both arms of the study are using high definition Olympus colonoscopes

Study design: A randomized controlled, noninferiority trial.

Sample size:

Existing literatures suggest that the detection rate of the DSC arm is 20%. The investigators set 10% as the non-inferiority margin. With a total of 400 subjects (200 in each arm), the study will have 80% power to detect non-inferiority with the type I error rate controlled at 0.05. To account for a potential 25% data attribution, the study team will enroll 500 subjects.

Statistical Analysis:

The baseline characteristics of the two trial arms will first be tabulated for potential imbalance in variables. Continuous variables will be summarized by typical parameters such as mean, standard deviation and range and compared using two-sample T-test (if the normality assumption holds) or Wilcoxon rank-sum test (if the normality assumption does not hold). Normality of distribution will be determined using the Kolmogorov-Smirnov goodness-of-fit test. Categorical data will be summarized by frequency and percentage and analyzed using the Chi-square or Fishers exact test, as appropriate.

The primary outcome will be compared using Z-test based on normal approximation of the sample proportions.

Outcome analysis:

Primary outcome analysis: Intention to treat Secondary outcome analysis: Per protocol analysis.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Burlington, Massachusetts, United States, 01803
      • Lahey Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient age ≥18yr old
2. History of UC or colonic Crohn's disease or unclassified colitis patients with or without colonic adenoma history
3. Duration of ≥ eight years since diagnosis, or any duration with a diagnosis of primary sclerosing cholangitis
4. Mucosal lesion involves ≥ 1/3 of the colon

Exclusion Criteria:

1. History of colorectal cancer
2. History of total colectomy
3. Prior colonoscopy within the last 6 months
4. Allergy to dye spray
5. Poor bowel preparation
6. Unable to provide informed consent
7. Severe inflammation preventing visualization of the mucosa during the procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Definition White Light Colonoscopy	Device: High Definition Colonoscopy; A colonoscopy that used high definition (HD) camera
Active Comparator: Dye Spraying Chromo-colonoscopy	Device: Dye Spraying Chromocolonoscopy; A colonoscopy that used high definition camera in addition to dye spraying on the interior colon surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Detection rate of Adenoma in both groups.	Immediately after the procedure
Detection rate of high-grade dysplasia in both groups.	Immediately after the procedure
Numbers of detected adenomas per patient.	Immediately after the procedure
Difference in withdrawal time to perform the procedure in both groups.	Immediately after the procedure
Difference in adverse event, mild (e.g.; nausea, vomiting, or abdominal pain that necessitate phone call from the patient to the provider, or sever (e.g.; GI bleeding, perforation, hospitalization after the procedure) for each arm.	Within one week from the procedure date
Number of targeted chromoendoscopies	Immediately after the procedure
Appropriateness of reported follow up recommendations per standard guideline recommendations	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 10, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Inflammatory bowel disease; Colorectal cancer screening; Chromocolonoscopy; High definition white light colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Inflammatory Bowel Diseases; Intestinal Diseases; Colitis
• Other Study ID Numbers: 2018P000795

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No