Colonoscopy Techniques for Inflammatory Bowel Disease

Recruiting in Burlington (>99 mi)

+1 other location

Overseen By Mohammed El-Dallal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Colorectal cancer, Total colectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is colonoscopy safe for patients with inflammatory bowel disease?

Colonoscopy, including techniques like dye-spraying chromoendoscopy and high-definition colonoscopy, is generally considered safe for patients with inflammatory bowel disease, although specific safety data is limited. These procedures are commonly used for monitoring and detecting changes in the colon, and while they are safe, they may be less comfortable for patients with severe inflammation. ^{1 2 3 4 5}

How does the treatment Dye Spraying Chromocolonoscopy differ from other treatments for inflammatory bowel disease?

Dye Spraying Chromocolonoscopy is unique because it involves spraying a dye during a colonoscopy to enhance the visibility of the colon lining, making it easier to detect abnormal areas that might indicate dysplasia (abnormal cells that could lead to cancer). This technique is particularly useful for patients with long-standing inflammatory bowel disease, as it provides a more detailed view compared to standard colonoscopy methods. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Dye Spraying Chromocolonoscopy, High Definition Colonoscopy for Inflammatory Bowel Disease?

Research shows that dye-spraying chromoendoscopy, a technique that uses special dyes to highlight areas in the colon, improves the detection of abnormal growths in patients with inflammatory bowel disease. This method is recommended by major medical societies for better detection of dysplasia (abnormal cells that can lead to cancer) compared to standard white light colonoscopy. ^{5 6 9 10 11}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a history of Ulcerative Colitis, Crohn's disease affecting the colon, or unclassified colitis lasting at least eight years, or any duration if also diagnosed with primary sclerosing cholangitis. Participants must have significant colon involvement and not had a total colectomy or recent colonoscopy.

Inclusion Criteria

I have a history of ulcerative colitis, Crohn's disease, or unspecified colitis, with or without a history of colon polyps.

My colon lesion affects more than one-third of it.

I was diagnosed over 8 years ago or have primary sclerosing cholangitis.

Exclusion Criteria

Prior colonoscopy within the last 6 months

Poor bowel preparation

I have had my entire colon removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo either High Definition White Light Colonoscopy (HDWLC) with biopsies every 10 cm or Dye Spraying Chromo-colonoscopy (DSC) based on randomization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the colonoscopy procedure

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dye Spraying Chromocolonoscopy
• High Definition Colonoscopy

Trial Overview The study compares two techniques to screen for cancer in patients with long-term IBD: High Definition Colonoscopy (HDC) versus Dye Spraying Chromocolonoscopy (DSC), using high-definition cameras to detect abnormal growths in the colon.

How Is the Trial Designed?

Group I: High Definition White Light Colonoscopy Experimental Treatment 1 Intervention

Group II: Dye Spraying Chromo-colonoscopy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

Patients with inflammatory bowel disease (IBD) affecting the colon have a higher risk of colon cancer, making regular endoscopic surveillance crucial for early detection.

Chromoendoscopy, which uses special dyes during colonoscopy, has been shown to significantly improve the detection of dysplasia compared to traditional white light endoscopy and random biopsies, suggesting it should be the preferred method for colorectal cancer surveillance in IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Surveillance in Long-standing Colitis. Boland, BS., Shergill, A., Kaltenbach, T.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Chromoendoscopy for Dysplasia Surveillance in Inflammatory Bowel Disease. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Chromocolonoscopy. [2015]

3. Turkey pubmed.ncbi.nlm.nih.gov

Concordance of Dye-Spraying Chromoendoscopy and Virtual Chromoendoscopy for Colonic Dysplasia Detection in Longstanding Inflammatory Bowel Disease. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of Virtual-based Chromoendoscopy Compared With Dye-spraying Chromoendoscopy Standard and High-definition White Light Endoscopy in Patients With Inflammatory Bowel Disease at Increased Risk of Colon Cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Surveillance in Long-standing Colitis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Chromoendoscopy-targeted biopsies are superior to standard colonoscopic surveillance for detecting dysplasia in inflammatory bowel disease patients: a prospective endoscopic trial. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Colorectal cancer surveillance in inflammatory bowel disease: A critical analysis. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Safety, feasibility, and tolerability of ileocolonoscopy in inflammatory bowel disease. [2008]

9. England pubmed.ncbi.nlm.nih.gov

Chromoendoscopy With Indigo Carmine vs Virtual Chromoendoscopy (iSCAN 1) for Neoplasia Screening in Patients With Inflammatory Bowel Disease: A Prospective Randomized Study. [2022]

10. Egypt pubmed.ncbi.nlm.nih.gov

Modern Endoscopic Imaging in Diagnosis and Surveillance of Inflammatory Bowel Disease Patients. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial Comparing High Definition Colonoscopy Alone With High Definition Dye Spraying and Electronic Virtual Chromoendoscopy for Detection of Colonic Neoplastic Lesions During IBD Surveillance Colonoscopy. [2019]