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Trial registered on ANZCTR


Registration number
ACTRN12617001364369
Ethics application status
Approved
Date submitted
14/09/2017
Date registered
27/09/2017
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Endocuff-vision assisted chromoendoscopy for surveillance for cancer and dysplasia in inflammatory bowel disease
Scientific title
Endocuff-vision assisted chromoendoscopy for surveillance for cancer and dysplasia in inflammatory bowel disease
Secondary ID [1] 292873 0
Nil Known
Universal Trial Number (UTN)
U1111-1202-0415
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 304722 0
Colorectal Cancer 304723 0
Condition category
Condition code
Oral and Gastrointestinal 304030 304030 0 0
Inflammatory bowel disease
Cancer 304031 304031 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a back-to-back crossover tandem colonoscopy study comparing the Endocuff device and standard care (high definition white light endoscopy with chromoendoscopy) compared with standard care alone for dysplasia surveillance in patients with inflammatory bowel disease. The Endocuff device is a small cap that attaches to the end of a standard colonoscope. Small, soft, finger-like projections extend from this cap on withdrawal of the colonoscope with the aim of flattening mucosal folds, anchoring the colonoscope and thus improving rate of dysplasia detection. The colonoscopies will be performed by endoscopists with training and experience in performing dye-spray chromoendoscopy, interventional endoscopy and who have had previous experience using the Endocuff device. All patients will receive two passes with the colonoscopy (one standard, and one with Endocuff) during the same anaesthetic, on the same day. Approximate length of each procedure will be about 15-20 minutes with a few minutes between crossover. This will occur at an endoscopy suite within Eastern Health. Follow-up will be via phone call at days 1, 7 and 21 post-procedure.
Intervention code [1] 299115 0
Early detection / Screening
Comparator / control treatment
There will be an active control group in this study. Patients will act as their own control in this back-to-back crossover tandem study, and they will be randomised to receive the control (high definition white light endoscopy with chromoendoscopy) or the intervention (Endocuff with high definition white light endoscopy with chromoendoscopy) first or second.
Control group
Active

Outcomes
Primary outcome [1] 303362 0
Dysplastic lesion miss rate: as defined as the number of lesions detected on the second colonoscopy which was missed during the first colonoscopy (regardless of Endocuff use or standard colonoscopy)
Timepoint [1] 303362 0
During colonoscopy
Primary outcome [2] 303375 0
Dysplasia detection rate: as defined as the number of participants with one or more dysplastic lesions (adenomas with low-grade dyspalasia, adenomas with high-grade dysplasia, carcinoma insitu, invasive carcinoma)
Timepoint [2] 303375 0
During colonoscopy and confirmation with histology after colonoscopy
Secondary outcome [1] 338744 0
Polypoid lesion detection rate: as defined as the number of participants with one or more polyps removed during the procedure
Timepoint [1] 338744 0
During colonoscopy and confirmation with histology after colonoscopy
Secondary outcome [2] 338745 0
Caecal intubation rate: as defined as proportion of colonoscopies where the caecum is reached and inspected - a marker of quality during colonoscopy
Timepoint [2] 338745 0
During colonoscopy
Secondary outcome [3] 338763 0
Caecal intubation time: as defined as the time it takes for the proceduralist to reach the caecum during the colonoscopy - a marker of quality during colonoscopy
Timepoint [3] 338763 0
During colonoscopy
Secondary outcome [4] 338764 0
Terminal ileum intubation rate: as defined as the proportion of colonoscopies where the terminal ileum is able to be intubated
Timepoint [4] 338764 0
During colonoscopy
Secondary outcome [5] 338765 0
Terminal ileum intubation time: as defined as the time it takes for the proceduralist to reach the terminal ileum during colonoscopy
Timepoint [5] 338765 0
During colonoscopy
Secondary outcome [6] 338766 0
Withdrawal time (not including polypectomy): as defined as the amount of time it takes for the proceduralist to withdraw the colonoscope, inspecting the bowel mucosa for lesions and taking biopsies - a marker of quality for colonoscopy
Timepoint [6] 338766 0
During colonoscopy
Secondary outcome [7] 338767 0
Adverse events (including mucosal trauma, bleeding, perforation, pain) will be assessed via history and examination and investigations (blood tests and CT scans) if history is suggestive
Timepoint [7] 338767 0
During colonoscopy, to day 21, via phone calls and clinic reviews for the patient

Eligibility
Key inclusion criteria
All patients with ulcerative colitis or Crohn’s colitis involving more than one third of the colon in clinical remission, planned for routine colonoscopy for dysplasia surveillance.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with absolute or relative contraindications to colonoscopy
• Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
• Patients with known colon cancer or polyposis syndromes
• Patients with known colonic strictures
• Patients with a known severe diverticular segment (that is likely to impede colonoscope passage);
• Patients with clinical suspicion of active ulcerative colitis
• Patients lacking capacity to give informed consent
• Patients on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure
• Patients who are attending for a therapeutic procedure or assessment of a known lesion
• Pregnancy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Based on assumption of adenoma miss rate of Endocuff-assisted colonoscopy of 7%, compared with 41% using standard colonoscopy (based upon the FUSION study[1]), a sample size of 40 paired procedures would provide the trial with 90% power to detect this difference on a two-sided level of 0.05. To account for drop out rate due to inadequate bowel preparation, active IBD colitis or unexpected diverticular disease and strictures, a recruitment target of 60 paired procedures (120 tandem colonoscopies in total) is aimed for.

Data analyses will be performed using Stata v12, Microsoft Excel and SPSS. Descriptive statistics will be collected and published in accordance with endoscopic indices. A stratified analysis or multivariate model will be employed to adjust results for the potential confounding influence of bowel preparation quality.

[1] Leong RW, Ooi M, Corte C, Yau Y, Kermeen M, Katelaris PH, McDonald C, Ngu M. Full-Spectrum Endoscopy Improves Surveillance for Dysplasia in Patients With Inflammatory Bowel Diseases. Gastroenterology 2017; 152:1337-44. e3.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8993 0
Maroondah Hospital - Ringwood East
Recruitment hospital [2] 8994 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 17494 0
3135 - Ringwood East
Recruitment postcode(s) [2] 17495 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 297502 0
Hospital
Name [1] 297502 0
Box Hill Hospital, Victoria
Address [1] 297502 0
Department of Gastroenterology, Level 3W, Building B, Box Hill Hospital, 8 Arnold St, Box Hill, VIC, 3128
Country [1] 297502 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
8 Arnold St, Box Hill, Victoria, 3128
Country
Australia
Secondary sponsor category [1] 296509 0
None
Name [1] 296509 0
Address [1] 296509 0
Country [1] 296509 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298602 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 298602 0
The Office of Research and Ethics
Level 2
5 Arnold Street
Box Hill
VIC 3128
Ethics committee country [1] 298602 0
Australia
Date submitted for ethics approval [1] 298602 0
01/08/2017
Approval date [1] 298602 0
15/08/2017
Ethics approval number [1] 298602 0
LR 90/2016

Summary
Brief summary
Patients with ulcerative colitis or Crohn's colitis have a slightly higher risk of bowel cancer after having the disease for a number of years. Colonoscopy is recommended to find polyps which can be flat and sometimes difficult to detect. This study aims to test the safety and efficacy of a new device named the Endocuff-vision, for surveillance for cancer and dysplasia in inflammatory bowel disease.

Who is it for?
You may be eligible to join this study if you aged 18 years or above and have ulcerative colitis or Crohn’s colitis involving more than one third of the colon in clinical remission, and are planned for routine colonoscopy for dysplasia surveillance.

Study details
All participants in this study will proceed with regular colonoscopy with the addition of the use of Endocuff-vision equipment during the procedure. This is a soft, rubber-like cap that fits to the end of the regular colonoscopy equipment, with a row of finger-like projections that extend when the colonoscope is pulled out. The aim of this device is to assist in anchoring the bowel wall and flattening mucosal folds to allow better vision of the bowel. The duration of the colonoscopy will be longer by about 10 - 15 minutes, as we will do the colonoscopy first without the Endocuff-vision device, then with the Endocuff-vision device, or vice versa.

All test results will be analysed to determine whether the Endocuff-vision device is objectively better at detecting polyps. A member of the research team will also contact study participants at 21 days after the colonoscopy to ascertain if there have been any complications.
Trial website
Trial related presentations / publications
Fang W, Haridy J, Keung C, Van Langenberg D, Garg M. Endocuff-Vision Assisted Colonoscopy for Surveillance of Cancer and Dysplasia in Ulcerative Colitis.

Poster presented at Australian Gastroenterology Week 2017
Public notes

Contacts
Principal investigator
Name 77626 0
Dr Mayur Garg
Address 77626 0
Department of Gastroenterology
Level 3W Building B
Box Hill hospital
8 Arnold Street,
Box Hill
Victoria 3128
Country 77626 0
Australia
Phone 77626 0
+61 3 90949555
Fax 77626 0
+61 3 9982 2159
Email 77626 0
Mayur.Garg@easternhealth.org.au
Contact person for public queries
Name 77627 0
Dr Wendy Fang
Address 77627 0
Department of Gastroenterology
Level 3W Building B
Box Hill hospital
8 Arnold Street,
Box Hill
Victoria 3128
Country 77627 0
Australia
Phone 77627 0
+61 3 90949555
Fax 77627 0
Email 77627 0
wendy.fang@easternhealth.org.au
Contact person for scientific queries
Name 77628 0
Dr Mayur Garg
Address 77628 0
Department of Gastroenterology
Level 3W Building B
Box Hill hospital
8 Arnold Street,
Box Hill
Victoria 3128
Country 77628 0
Australia
Phone 77628 0
+61 3 90949555
Fax 77628 0
Email 77628 0
mayur.garg@easternhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results