Clinical trial NCT04191655: High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)
Official title: High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Colon Dysplasia
Ulcerative Colitis
Crohn Colitis
Indeterminate Colitis
Keywords: Colorectal cancer screening
Inflammatory bowel disease
Chromocolonoscopy
High definition white light colonoscopy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After patients consent to participate to the study, they will be randomized 1:1 by one of the study members who is blinded to the patient's history to either High Definition White Light Colonoscopy with biopsies every 10 cm or Dye Spraying Chromocolonoscopy. The gastroenterologist will be informed about the randomization result and s/he will conduct the procedure.
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Detection rate of Adenoma in both groups.
timeFrame: Immediately after the procedure
measure: Detection rate of high-grade dysplasia in both groups.
timeFrame: Immediately after the procedure
measure: Numbers of detected adenomas per patient.
timeFrame: Immediately after the procedure
measure: Difference in withdrawal time to perform the procedure in both groups.
timeFrame: Immediately after the procedure
measure: 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.
timeFrame: Within one week from the procedure date
measure: Number of targeted chromoendoscopies
timeFrame: Immediately after the procedure
measure: Appropriateness of reported follow up recommendations per standard guideline recommendations
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
Study officials:
References: