IBD Neoplasia Surveillance Pilot RCT

Inflammatory Bowel Diseases Clinical Trial

— IBDDysplasia  

Official title:

A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067778
• Other study ID #: 20190428-01T
• Status: Completed
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: October 6, 2022

Study information

• Verified date: March 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion capture rate, side-effects and CRC risk. The pilot study will aim to capture 20% of the overall study population in order to evaluate the feasibility of recruiting the needed number of participants in the specified time frame, while maintaining high quality of data collection.

Description:

Inflammatory Bowel Disease (IBD), including crohn's disease and ulcerative colitis, is a group of diseases characterized by acute and chronic inflammation of the intestinal tract. Persons with IBD are at an increased risk of developing colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Current IBD screening guidelines recommend the taking of biopsies of any lesions suspected to be pre-cancerous (targeted biopsies), as well as the taking of 30 to 40 random biopsies throughout the colon. The recommendations for random biopsies are based on historical practice and the theory that they would capture "invisible lesions", but are not supported by strong scientific evidence.

In fact, recent evidence has shown that random biopsies capture a very small number of pre-cancerous lesions and that they capture such lesions only in persons with additional risk factors for CRC. In addition, new colonoscopy practices and technology have made 80-90% of pre-cancerous lesions visible. Random biopsies also carry potential risks for patients, including lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural costs and time.

Hence, there is a strong impetus to conduct a well-powered non-inferiority Randomized Controlled Trial (RCT) on this topic in a Canadian setting. With the support of a pan-Canadian IBD clinical trials alliance (the Canadian IBD Research Consortium (CIRC)), and the high prevalence of IBD in Canada, Canadian investigators are well-positioned to undertake such a trial. Before embarking on a large multi-center trial, a one-year pilot feasibility trial will be conducted to ensure that patients can be enrolled efficiently with excellent protocol compliance. A feasibility trial will also provide a crude estimate of the neoplasia detection rate (primary outcome) among persons with colon IBD (cIBD) in Canada, which will allow refinement of the sample size, recruitment period and budget for a definitive trial. To-date, no well-powered or North American RCTs have evaluated random biopsies as an intervention to guide our estimates for a definitive trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 6, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old

• Historical endoscopic/histologic disease extending beyond the rectum in UC or involving = 1/3 of colorectum in CD

• > 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, =1/3 colorectum in CD

• cIBD = 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis)

• In symptomatic remission at time of colonoscopy

• For CD: Harvey-Bradshaw Index < 541

• For UC or IBDU: Partial Mayo Score = 242

• Major purpose of colonoscopy is neoplasia screening/surveillance

• Undergoing colonoscopy with high-definition white light endoscopy

Exclusion Criteria:

• Persons who cannot or are unwilling to provide informed consent

• Persons with a history of colorectal cancer

• Persons with prior subtotal or total colectomy (> 50% of colon removed)

• Persons undergoing colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year

• Persons undergoing pancolonic chromoendoscopy

• Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment)

• Incomplete colonoscopy (unable to reach cecum)

• Moderate-to-severe inflammation (Mayo 2-3) involving = 25% of colorectum or mild inflammation (Mayo 1) involving = 50% of colorectum

Related Conditions & MeSH terms

• Colonic Neoplasms
• Dysplasia
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Diagnostic Test:
• Intervention Group
Standard colonoscopy with targeted biopsies only
• Control Group
Standard colonoscopy with random AND targeted biopsies

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	Eastern Regional Health Authority	St. John's	NFLD
Canada	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Pacific Digestive Health / Royal Jubilee Hospital	Victoria	British Columbia
Canada	University of Manitoba, Health Sciences Centre	Winnipeg	Manitoba

Sponsors (13)

Lead Sponsor

Collaborator

Ottawa Hospital Research Institute

Eastern Health, Hamilton Health Sciences Corporation, Health Sciences Centre, Winnipeg, Manitoba, McGill University Health Centre/Research Institute of the McGill University Health Centre, MOUNT SINAI HOSPITAL, Nova Scotia Health Authority, Providence Health & Services, Royal Jubilee Hospital, Thunder Bay Regional Health Sciences Centre, University of Alberta, University of Toronto, Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Number of Participants Enrolled	Number of participants enrolled within one year from the overall total required.	1 year
Primary	Rate of Protocol Adherence	Rate of protocol adherence of major protocol violations on a per-patient basis.	1 year
Primary	Rate of overall neoplasia detection	Overall neoplasia detection rate for the definitive trial.	1 year
Primary	Adverse Events occurrence	Occurrence of serious and minor post-procedural adverse events within 2 weeks of procedure.	2 weeks
Secondary	Rate of Study Variables		1 year
Secondary	Rate of Missed 2-Week Post-Procedural Assessment for Complications		2 weeks