Colonoscopy Techniques for Inflammatory Bowel Disease

Not currently recruiting at 1 trial location
JF
ME
Overseen ByMohammed El-Dallal, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two colonoscopy techniques to determine which better detects early cancer signs in individuals with Inflammatory Bowel Disease (IBD). The trial evaluates the use of a dye spray during the procedure (Dye Spraying Chromocolonoscopy) versus a high-definition camera (High Definition Colonoscopy). It targets individuals who have had IBD affecting their colon for at least eight years or have a liver condition called primary sclerosing cholangitis. Participants should not have a history of colon cancer or have undergone a colonoscopy in the last six months. The aim is to identify the most effective method for early detection of potentially harmful changes in the colon. As an unphased trial, this study allows participants to contribute to significant research that could enhance early cancer detection methods for those with 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.

What prior data suggests that these colonoscopy techniques are safe for detecting neoplastic lesions in IBD patients?

Research has shown that both dye spraying chromo-colonoscopy and high-definition white light colonoscopy are safe for patients with inflammatory bowel disease (IBD). Studies have found no major differences in safety between these two methods, indicating that neither causes more side effects or complications than the other.

Dye spraying chromo-colonoscopy uses a special dye to highlight areas of the colon, helping doctors see any abnormal parts more clearly. It is easy to learn and helps identify certain changes in the colon. High-definition white light colonoscopy uses a camera with very clear images to detect changes. Both methods are effective and generally comfortable for patients, without causing major issues.

Prospective trial participants can feel reassured by the research. Both methods are standard and have been safely used for many years to check for colon cancer in people with long-term IBD.12345

Why are researchers excited about this trial?

Researchers are excited about these colonoscopy techniques for Inflammatory Bowel Disease (IBD) because they promise to enhance detection capabilities. Unlike standard colonoscopy, Dye Spraying Chromocolonoscopy uses a special dye to highlight subtle changes in the colon's lining, potentially revealing abnormalities that might otherwise go unnoticed. On the other hand, High Definition Colonoscopy offers sharper and more detailed images, increasing the chances of spotting problematic areas. By improving visualization, these methods could lead to better diagnosis and management of IBD, ultimately improving patient outcomes.

What evidence suggests that these colonoscopy techniques are effective for detecting neoplastic lesions in patients with long-standing IBD?

This trial will compare dye-spraying chromocolonoscopy with high-definition white light colonoscopy for monitoring inflammatory bowel disease (IBD). Research has shown that dye-spraying chromocolonoscopy might better detect abnormal cells that can lead to cancer in people with IBD. Studies have found it more effective than high-definition white light colonoscopy in spotting these abnormal areas. However, both methods offer advantages. High-definition colonoscopy alone has detected more abnormal cells compared to older techniques. For some, high-definition white light colonoscopy is a practical choice because it effectively finds new, abnormal tissue growth. Overall, evidence supports using both dye-spraying chromocolonoscopy and high-definition colonoscopy for monitoring IBD.16789

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.
See 4 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: High Definition White Light ColonoscopyExperimental Treatment1 Intervention
Group II: Dye Spraying Chromo-colonoscopyActive Control1 Intervention

Find a Clinic Near You

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

Citations

Concordance of Dye-Spraying Chromoendoscopy and ...In our study, dye-spraying chromoendoscopy and virtual chromoendoscopy had similar performance in lesion and dysplasia detection, as well as in margins ...
Comparative Efficacy and Safety of Endoscopic Modalities ...HD dye-based chromoendoscopy may improve dysplasia detection compared with other modalities like HD white light endoscopy, although evidence certainty is low.
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38038351/
An Updated Meta-Analysis of Randomized Controlled TrialsDye Chromoendoscopy Outperforms High-Definition White Light Endoscopy in Dysplasia Detection for Patients With Inflammatory Bowel Disease: An ...
IBD Surveillance Colonoscopy: to Spray or Not to Spray!The study supports the use of HD white-light endoscopy with reinspection as a practical alternative given its non-inferiority for neoplasia detection.
The use of chromoendoscopy for surveillance ...Chromoendoscopy is an exciting technique that can improve dysplasia detection in ulcerative colitis. It is simple, is easy to learn, and can increase dysplasia ...
High Definition Colonoscopy (HDC) Vs. Dye Spraying ...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 ...
The use of chromoendoscopy for surveillance ...Chromoendoscopy is an exciting technique that can improve dysplasia detection in ulcerative colitis. It is simple, is easy to learn, and can increase dysplasia ...
Chromoendoscopy for Surveillance in Ulcerative Colitis ...our data show that chromoendoscopy and high-definition white-light endoscopy have similar effectiveness in detecting inflammatory bowel disease ...
Oral Microcapsule Chromocolonoscopy With Patent Blue V ...In the PBM cohort, 97.1% (34/35) achieved an optimal to acceptable staining quality (SQ) score of ≥ 8, with a mean total score of 13.4 ± 2.9.
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