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

NCT04191655 | Completed

• 1 other identifier: 2018P000795
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

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.

Conditions

Colon Dysplasia; Ulcerative Colitis; Crohn Colitis; Indeterminate Colitis; Inflammatory Bowel Diseases

Keywords

Colorectal cancer screening; Inflammatory bowel disease; Chromocolonoscopy; High definition white light colonoscopy

Outcome Measures

Primary Outcomes (1)

• Detection rate of dysplastic lesions in High Definition White Light Colonoscopy versus Dye Spraying Chromo-colonoscopy

  Immediately after the procedure

Secondary Outcomes (7)

• 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

Study Arms (2)

High Definition White Light Colonoscopy

EXPERIMENTAL

Device: High Definition Colonoscopy

Dye Spraying Chromo-colonoscopy

ACTIVE COMPARATOR

Device: Dye Spraying Chromocolonoscopy

Interventions

Dye Spraying Chromocolonoscopy DEVICE

A colonoscopy that used high definition camera in addition to dye spraying on the interior colon surface.

Dye Spraying Chromo-colonoscopy

High Definition Colonoscopy DEVICE

A colonoscopy that used high definition (HD) camera

High Definition White Light Colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01803, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 10, 2019
• Study Start: April 3, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 6, 2026

Record last verified: 2025-03

Locations

US (2)