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

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ClinicalTrials.gov Identifier: NCT04191655
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph Feuerstein, Beth Israel Deaconess Medical Center

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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Colon Dysplasia Ulcerative Colitis Crohn Colitis Indeterminate Colitis Device: High Definition Colonoscopy Device: Dye Spraying Chromocolonoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

In this study, we will randomize a total of 500 participants into two arms: A. high definition white light colonoscopy with biopsy (n=250) or B. chromocolonoscopy (n=250).

The randomization schedule was created by using GraphPad website. Then sealed opaque envelopes which numbered from 1 to 500 for all subjects were created based on the randomization schedules by one of the study co-investigators (Mohammed El-Dallal MD). These envelopes will be opened only by the endoscopy provider once the subject agrees and sings the informed consent. Of note, the randomization schedules will be saved in a separate document that only Mohammed El-Dallal MD has access to it. Neither the participants nor the study members (other than Mohammed El-Dallal MD) know about the assignment before opening the envelopes.

Primary Purpose: Screening
Official Title: High Definition Colonoscopy (HDC) vs. Dye Spraying Chromo-colonoscopy (DSC) in Screening Patients With Long-standing Inflammatory Bowel Disease (IBD)
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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.




Primary Outcome Measures :
  1. Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy [ Time Frame: Immediately after the procedure ]

Secondary Outcome Measures :
  1. Detection rate of Adenoma in both groups. [ Time Frame: Immediately after the procedure ]
  2. Detection rate of high-grade dysplasia in both groups. [ Time Frame: Immediately after the procedure ]
  3. Numbers of detected adenomas per patient. [ Time Frame: Immediately after the procedure ]
  4. Difference in withdrawal time to perform the procedure in both groups. [ Time Frame: Immediately after the procedure ]
  5. 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. [ Time Frame: Within one week from the procedure date ]
  6. Number of targeted chromoendoscopies [ Time Frame: Immediately after the procedure ]
  7. Appropriateness of reported follow up recommendations per standard guideline recommendations [ Time Frame: Immediately after the procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191655


Contacts
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Contact: Mohammed El-Dallal, MD 6176652177 mohammed_el-dallal@hms.harvard.edu
Contact: Joseph Feuerstein MD, MD 6177548888 jfeuerst@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Joseph Feuerstein MD    617-407-9227    jfeuerst@bidmc.harvard.edu   
Principal Investigator: Joseph Feuerstein MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Joseph Feuerstein, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04191655    
Other Study ID Numbers: 2018P000795
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph Feuerstein, Beth Israel Deaconess Medical Center:
Colorectal cancer screening
Inflammatory bowel disease
Chromocolonoscopy
High definition white light colonoscopy
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases