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Trial registered on ANZCTR


Registration number
ACTRN12617000521325
Ethics application status
Approved
Date submitted
24/01/2017
Date registered
10/04/2017
Date last updated
16/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the miss rate of detecting adenoma using 2 imaging techniques during colonoscopy
Scientific title
Linked color imaging versus white light: a randomised tandem colonoscopy study of adenoma miss rates
Secondary ID [1] 291000 0
None
Universal Trial Number (UTN)
U1111-1191-9675
Trial acronym
LCI-AMR study
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Colonic Polyps 301770 0
Condition category
Condition code
Cancer 301460 301460 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional Procedure (Arm 1): Initial inspection with linked colour imaging (LCI) then white light (WL)

The procedure will be performed by qualified gastroenterologists (who also underwent additional advanced therapeutic colonoscopy training). They are A/Prof David Hewett (FRACP), Dr Nicholas Tutticci (FRACP) and Dr Ammar Kheir (FRACP).

The duration of the total procedure time will be approximately 30 - 40 minutes. Keeping in mind that insertion time to the caecum will average 5 minutes with minimum 6 minutes withdrawal time (as per national standard) for each insertion.

The device used is the new is the 7000 'Trademark' endoscopic system powered by Fujifilm’s unique 4-LED Multi Light 'Trademark' technology sets a new standard in light intensity and endoscopic imaging (this is equivalent to the European model ELUXEO 'Trademark'). The white light (WL) is essentially a high definition normal white light without manipulation of the normal light wavelengths. The Linked-colour imaging (LCI) creates clear and bright endoscopic images using short wavelength witha narrow-band light that enhances the vessels in on the mucosal surface and patterns of the mucosa (410-nm and 450-nm wavelengths with a bandwidth that is <2nm),

A research assistant will measure insertion and withdrawal times by using a stopwatch. On insertion, the stopwatch will be started at the moment the rectal mucosa is visualised, and timing will be continued until the colonoscope tip has entered the caecal caput. On withdrawal, mucosal inspection will be performed firstly using linked colour imaging until withdrawn to the rectum. Polyps will be removed as they are identified (via standard polypectomy techniques) and each polyp submitted separately for pathological examination.

Reinsertion will then be performed to the caecum and further mucosal inspection performed using white light until withdrawn to the rectum. Further detected polyps will be removed as they are identified (via standard polypectomy techniques) and each polyp submitted separately for pathological examination.
Intervention code [1] 296963 0
Treatment: Devices
Intervention code [2] 296964 0
Prevention
Intervention code [3] 297397 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator / Control Procedure (Arm 2): Initial inspection with white light (WL) then linked colour imaging (LCI)

A research assistant will measure insertion and withdrawal times by using a stopwatch. On insertion, the stopwatch will be started at the moment the rectal mucosa is visualised, and timing will be continued until the colonoscope tip has entered the caecal caput. On withdrawal, mucosal inspection will be performed firstly using white light until withdrawn to the rectum. Polyps will be removed as they are identified (via standard polypectomy techniques) and each polyp submitted separately for pathological examination.

Reinsertion will then be performed to the caecum and further mucosal inspection performed using linked colour imaging system until withdrawn to the rectum. Further detected polyps will be removed as they are identified (via standard polypectomy techniques) and each polyp submitted separately for pathological examination.
Control group
Active

Outcomes
Primary outcome [1] 300857 0
Adenoma miss rate

The adenoma miss rate is defined as the number of additional adenomas detected by the second assessment (WL or LCI) for each group divided by the total number of adenomas detected.
Timepoint [1] 300857 0
After the second colonoscopy inspection is completed.
Secondary outcome [1] 331056 0
Patient miss rate

This id defined as the number of patients with one or more additional adenomas detected by the second assessment (WL or LCI) for each group divided by the total number of patients with one or more adenomas detected.
Timepoint [1] 331056 0
Once all participants have been completed the procedure..
Secondary outcome [2] 331060 0
Applicability of LCI in optical diagnosis of colorectal polyps using the NICE (NBI International Colorectal Endoscopic) classification.
Timepoint [2] 331060 0
Once all participants have completed the procedure.
Secondary outcome [3] 332439 0
Optical Diagnosis of colorectal Polyps using LCI (Diagnostic Test Performance)

For this outcome, we will assess the diagnostic test performance of the endoscopic prediction of polyp histology using LCI and correlate that with the "gold-standard" pathological diagnosis of polyps.

Diagnostic test performance will be assessed using accuracy, sensitivity, specificity and NPV.
Timepoint [3] 332439 0
Once all participants have been completed the procedure.
Secondary outcome [4] 332440 0
Optical Diagnosis of colorectal Polyps using LCI (inter and intra observer reliability)

For this outcome, we will assess the inter-observer and intra-observer agreement performance for optical diagnosis of colorectal polyps using LCI. This will be measured using Fleiss Kappa and Kappa, respectively.
Timepoint [4] 332440 0
Once all participants have been completed the procedure.

Eligibility
Key inclusion criteria
All patients undergoing elective colonoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients under 18 years of age
- Complex cases for advanced therapeutic colonoscopy (endoscopic mucosal resection, endoscopic submucosal dissection, colonic stenting, colonic dilatation, colonic strictures)
- Previous surgical resection of the colon or rectum

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed envelopes (SNOSE).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The following assumptions were used to calculate required sample size: 30% adenoma miss rate for white light inspection and 10% miss rate for linked colour imaging inspection; two thirds of patients will have at least one adenoma, and patients with polyps will have an average of 3.7 polyps [as per previous study by Hewett and Rex (Gastrointest Endosc 2010; 72: 77581)].

For the study to have 80% power to detect 3 fold reduction in adenoma miss rates, by using a chi square test with 5% significance level, the study will need 62 polyps per group (i.e. 124 polyps total). Thus recruitment of 100 patients (n=100, with n=50 per arm) will ensure that the study will fulfill the above criteria with a power of 80%.

alpha = 0.05 , power = 0.8 , delta = 0.2

For characterisation, 60 consecutive images will be used and 60 consecutive videos (5-10 seconds in white light, 5-10 seconds in LCI). Accuracy, sensitivity, specificity and NPV will be measured. Inter-observer and intra-observer agreement will be measured (Fleiss Kappa and Kappa, respectively).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/04/2017
Actual
Date of last participant enrolment
Anticipated
5/02/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7385 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 15178 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 295425 0
Hospital
Name [1] 295425 0
Queen Elizabeth II Jubilee Hospital
Country [1] 295425 0
Australia
Primary sponsor type
Hospital
Name
Queen Elizabeth II Jubilee Hospital
Address
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD, 4108, Australia.
Country
Australia
Secondary sponsor category [1] 294245 0
None
Name [1] 294245 0
Address [1] 294245 0
Country [1] 294245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296758 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 296758 0
Ethics committee country [1] 296758 0
Australia
Date submitted for ethics approval [1] 296758 0
22/09/2016
Approval date [1] 296758 0
17/11/2016
Ethics approval number [1] 296758 0
HREC/16/QPAH/639

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1386 1386 0 0
/AnzctrAttachments/372228-SSA-16-640_Approved_Letter[1].pdf (Ethics approval)
Attachments [2] 1387 1387 0 0
/AnzctrAttachments/372228-LCI-AMR Polyp Record Sheet_DH14Sep 14Oct (2).docx (Supplementary information)
Attachments [3] 1388 1388 0 0
/AnzctrAttachments/372228-SSA-16-640_Approved_RCASE[1].pdf (Supplementary information)
Attachments [4] 1389 1389 0 0
/AnzctrAttachments/372228-LCI-AMR consent form_v2_13Oct Kheir.doc (Participant information/consent)
Attachments [5] 1390 1390 0 0
/AnzctrAttachments/372228-LCI-AMR Protocol V1.1.doc (Protocol)
Attachments [6] 1391 1391 0 0
/AnzctrAttachments/372228-LCI-AMR SAE form V1.doc (Supplementary information)

Contacts
Principal investigator
Name 71970 0
Dr Ammar Kheir
Address 71970 0
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD 4108, Australia
Country 71970 0
Australia
Phone 71970 0
+61 424266194
Fax 71970 0
Email 71970 0
ammarkheir@gmail.com
Contact person for public queries
Name 71971 0
Ammar Kheir
Address 71971 0
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD 4108, Australia
Country 71971 0
Australia
Phone 71971 0
+61 424266194
Fax 71971 0
Email 71971 0
ammarkheir@gmail.com
Contact person for scientific queries
Name 71972 0
Ammar Kheir
Address 71972 0
Endoscopy Unit, Queen Elizabeth II Jubilee Hospital, Cnr Kessels & Troughton Roads, Coopers Plains, QLD 4108, Australia
Country 71972 0
Australia
Phone 71972 0
+61 424266194
Fax 71972 0
Email 71972 0
ammarkheir@gmail.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.