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Trial registered on ANZCTR


Registration number
ACTRN12616000047493
Ethics application status
Approved
Date submitted
5/01/2016
Date registered
19/01/2016
Date last updated
19/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Full Spectrum Endoscopy (FUSE) colonoscopy versus conventional forward-viewing colonoscopy in the detection of dysplasia in patients with chronic inflammatory bowel diseases .
Scientific title
Randomized tandem colonoscopy study of Full Spectrum Endoscopy (FUSE) versus conventional colonoscopy in the detection of inflammatory bowel disease neoplasia
Secondary ID [1] 288242 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
FUSION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inflammatory bowel diseases 297173 0
colorectal cancer 297174 0
Condition category
Condition code
Oral and Gastrointestinal 297388 297388 0 0
Inflammatory bowel disease
Cancer 297389 297389 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomized order of colonoscopy type (conventional versus FUSE colonoscopy) to determine the miss rates of colonoscopy type.
The intervention is the use of the FUSE colonoscope which is a colonoscope that incorporates 3 cameras on the colonoscope tip to provide a panoramic 330-degree field of view. .The size and function of the FUSE colonoscope is otherwise the same as the conventional colonoscope (control). Both instruments visualise the internal lining of the bowel and permit the identification and removal of neoplasia.
All subjects will have both procedures performed back-to-back ("crossover tandem colonoscopy") but the order of the procedure will be randomized. The effect is that the second procedure will determine if lesions were missed during the first procedure, and which colonoscope can identify more neoplasia.
Both colonoscopies are expected to be equivalent in duration, taking 15-25 minutes. Quality indicator is that colonoscopy withdrawal should be of at least 6 minutes to improve the chances of not missing pathology.
Both colonoscopies are conducted by investigators who are experienced in surveillance colonoscopies and accredited endoscopists. The histopathologists are from the Department of Pathology and familiar with the identification and interpretation of IBD dysplasia. Where dysplasia is found, a second gastrointestinal pathologist will assist with the grading through consensus. Both pathologists are blinded to the order of the colonoscopy (which is coded). There is no need for a wash out, as this is not a drug trial. The second colonoscopy is inserted as soon as the processor is connected and switched on, which usually takes 4-5 minutes. The patient remains under sedation during the intervening period and we wish to keep that as brief as possible.
Intervention code [1] 293527 0
Early detection / Screening
Intervention code [2] 293584 0
Diagnosis / Prognosis
Comparator / control treatment
Conventional colonoscopy utilizes a single forward-viewing camera.that provides a 170-degree field of view.
Patients with inflammatory bowel diseases currently receive conventional colonoscopies for their surveillance for neoplasia as standard care.
Both colonoscopies are expected to be equivalent in duration, taking 15-25 minutes. Quality indicator is that colonoscopy withdrawal should be of at least 6 minutes to improve the chances of not missing pathology.
Both colonoscopies are conducted by investigators who are experienced in surveillance colonoscopies and accredited endoscopists. The histopathologists are from the Department of Pathology and familiar with the identification and interpretation of IBD dysplasia. Where dysplasia is found, a second gastrointestinal pathologist will assist with the grading through consensus. Both pathologists are blinded to the order of the colonoscopy (which is coded). There is no need for a wash out, as this is not a drug trial. The second colonoscopy is inserted as soon as the processor is connected and switched on, which usually takes 4-5 minutes. The patient remains under sedation during the intervening period and we wish to keep that as brief as possible.
Control group
Active

Outcomes
Primary outcome [1] 296935 0
Dysplasia miss rates on a per-lesion analysis
Timepoint [1] 296935 0
Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures.
Secondary outcome [1] 319730 0
Dysplasia identification on a per-patient analysis.
Timepoint [1] 319730 0
Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures.
Secondary outcome [2] 319731 0
The mean number of dysplastic lesions found on FVC versus FUSE
Timepoint [2] 319731 0
Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures.
Secondary outcome [3] 319732 0
The procedural insertion and withdrawal times
Timepoint [3] 319732 0
Following completion of both colonoscopies and calculation of the time taken to perform each of the colonoscopies.
Secondary outcome [4] 319733 0
The yield of dysplasia of targeted biopsies compared against random biopsies with- and without chromoendoscopy
Timepoint [4] 319733 0
Following completion of both colonoscopies and histological confirmation of the lesions removed during the procedures.
Secondary outcome [5] 319734 0
Complication rate comparing conventional colonoscopy with FUSE. Assessing complications such as abdominal pain or need for readmission to hospital.
Timepoint [5] 319734 0
30-days after the the procedure based on a telephone call to the subject.

Eligibility
Key inclusion criteria
18-80 years
Eligible for inclusion into the IBD Surveillance Program according to the NHMRC guidelines - that is patients with colitis (at least 1/3 extent of the bowel) of at least 8 years duration.
Those with concurrent primary sclerosing cholangitis or prior colonic dysplasia are eligible immediately (rather than at 8 years)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior colonoscopy surveillance procedure within the past 12 months (or within 2 years for low-risk cases).
Adverse effects or contraindications to methylene blue chromoendoscopy (dye spray into the bowel is standard surveillance procedure during surveillance).
Pregnancy
Lactation
Severe comorbidities
Prior colon resection (apart from limited caecal resection as part of ileal resection)
Active inflammatory colitis (preventing adequate chromoendoscopy)
Unable to complete colonoscopy (failure or poor bowel preparation)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomized code concealed by sealed opaque envelope is revealed only after patient consent was obtained and prior to colonoscopy procedure.

Patients are blinded to the colonoscopy order.
The histopathologist, who interprets the lesions removed during both colonoscopy procedures, is blinded to which colonoscope removed the lesions (coded as "colonoscope A" or "B" only).
The endoscopist cannot be blinded due to the differences between the two colonoscope types.
Data analyst could not been blinded as the lesions were identified according to which monitor (either central, left or right) in which the lesion was first identified. . . . .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random code sequence
No stratification was required
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Based on a previous publication of FUSE compared against conventional colonoscopy in a screening population, the adenoma-miss rates of 7% with FUSE and 41% with conventional colonoscopy was found. On a 2 sample proportion analysis, a sample size of 32 procedures in each group would be required to deliver 80% power for a 2-sided alpha of 0.05. To account for drop out due to active IBD colitis prohibiting adequate chromoendoscopy and possibly low dysplasia rates in patients already on an IBD surveillance program, a recruitment target of 55 paired procedures (110 tandem colonoscopies) was calculated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/02/2014
Date of last participant enrolment
Anticipated
30/04/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 12489 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 292621 0
Hospital
Name [1] 292621 0
Concord Hospital
Country [1] 292621 0
Australia
Primary sponsor type
Hospital
Name
Concord Hospital
Address
Concord Hospital
Level 1 West,
1 Hospital Rd
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 291339 0
Commercial sector/Industry
Name [1] 291339 0
Endochoice
Address [1] 291339 0
EndoChoice Inc.
11810 Wills Rd.
Alpharetta, GA 30009
Country [1] 291339 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294106 0
Concord Hospital
Ethics committee address [1] 294106 0
Ethics committee country [1] 294106 0
Australia
Date submitted for ethics approval [1] 294106 0
18/11/2013
Approval date [1] 294106 0
05/02/2014
Ethics approval number [1] 294106 0
CH62/6/2013-207

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62490 0
Prof Rupert Leong
Address 62490 0
Concord Hospital
Ambulatory Care Endoscopy Unit
Level 1 West
Hospital Rd
Concord Hospital NSW 2139
Country 62490 0
Australia
Phone 62490 0
+61297676111
Fax 62490 0
+61297676767
Email 62490 0
[email protected]
Contact person for public queries
Name 62491 0
Rupert Leong
Address 62491 0
Concord Hospital
Ambulatory Care Endoscopy Unit
Level 1 West
Hospital Rd
Concord Hospital NSW 2139
Country 62491 0
Australia
Phone 62491 0
+61297676111
Fax 62491 0
+61297676767
Email 62491 0
[email protected]
Contact person for scientific queries
Name 62492 0
Rupert Leong
Address 62492 0
Concord Hospital
Ambulatory Care Endoscopy Unit
Level 1 West
Hospital Rd
Concord Hospital NSW 2139
Country 62492 0
Australia
Phone 62492 0
+61297676111
Fax 62492 0
+61297676767
Email 62492 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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