Clinical trial NCT04067778: IBD Neoplasia Surveillance Pilot RCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Colonic Neoplasms
Dysplasia
Keywords: IBD
Dysplasia
Biopsy
Colonoscopy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre, Winnipeg, Manitoba
name: Western University, Canada
name: University of Toronto
name: Hamilton Health Sciences Corporation
name: Thunder Bay Regional Health Sciences Centre
name: Eastern Health
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Providence Health & Services
name: Royal Jubilee Hospital
name: University of Alberta
name: MOUNT SINAI HOSPITAL
name: Nova Scotia Health Authority
First posted: 2019-08-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Number of Participants Enrolled
timeFrame: 1 year
measure: Rate of Protocol Adherence
timeFrame: 1 year
measure: Rate of overall neoplasia detection
timeFrame: 1 year
measure: Adverse Events occurrence
timeFrame: 2 weeks
Secondary outcomes:
measure: Rate of Study Variables
timeFrame: 1 year
measure: Rate of Missed 2-Week Post-Procedural Assessment for Complications
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Pacific Digestive Health / Royal Jubilee Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba, Health Sciences Centre
state: Manitoba
city: St. John's
country: Canada
facility: Eastern Regional Health Authority
state: NFLD
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: