Assessing the additional benefit of an innovative imaging system for colonoscopy

ISRCTN	ISRCTN10357435
DOI	https://doi.org/10.1186/ISRCTN10357435
Protocol serial number	351
Sponsor	CPO Piemonte
Funder	Regional Health Authority, Piedmont Region (Italy)

Submission date: 17/09/2015
Registration date: 18/09/2015
Last edited: 04/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
A colonoscopy is an important procedure in which a narrow, flexible, telescopic camera is inserted into the back passage to look at the lining of the large bowel. Although it can be an uncomfortable procedure, it is the most effective way to diagnose colorectal cancer (bowel cancer). Although colonoscopies are very effective at finding tumours (neoplasms), it is reported that they do not always spot polyps. A polyp is a very small growth on the inner lining of the colon or rectum. Although most colorectal polyps do not become cancerous, almost all cases of colorectal cancer begin as polyps. It is therefore very important to detect polyps, as their presence increases the risk of colorectal cancer. A possible reason that polyps are sometimes missed in colonoscopies may be because of inadequate equipment. A full spectrum endoscope (FUSE) is a device that has been developed to help lower the miss rate of polyps in routine colonoscopies. The device uses three cameras to give a panoramic view of the colon, allowing for a more complete picture of the colon. The aim of this study is to find out how well this new technology performs in comparison to the standard device used.

Who can participate?
Adults between 50 and 69 years of age, having their first colonoscopy after testing positively for blood in their stool in a mass screening programme.

What does the study involve?
Participants are randomly allocated in one of two groups. For participants in the first group, the colonoscopy procedure is completed using a standard forward-viewing colonoscopy. For participants in the second group, the procedure is completed using full spectrum endoscopy (FUSE). After the procedures, the accuracy of the two devices is compared. Participants also are asked to complete a questionnaire after the procedure about their experiences.

What are the possible benefits and risks of participating?
A potential benefit for participants in the FUSE group is that the procedure may reveal polyps that otherwise might have been missed. There are no risks of participating other than the standard risks involved with having a colonoscopy. Additionally, some additional polyps detected with the new instrument might not be clinically significant.
Where is the study run from?
Seven hospitals in Italy.

When is the study starting and how long is it expected to run for?
September 2014 to October 2015

Who is funding the study?
Regional Health Authority, Piedmont Region (Italy)

Who is the main contact?
Dr Carlo Senore
carlo.senore@cpo.it

Contact information

Dr Carlo Senore
Scientific

Via S Francesco da Paola 31
Turin
10123
Italy

Phone	+39 011 6333890
Email	carlo.senore@cpo.it

Study information

Primary study design	Interventional
Study design	Multi-centre stratified randomised parallel trial
Secondary study design	Randomised parallel trial
Scientific title	Assessing the additional neoplasia yield of FUll Spectrum Endoscopy in a CRC screening setting
Study acronym	FUSE
Study objectives	The use of an instrument ensuring a wider view of the colonic mucosa would result in a higher rate of detection of significant colonic lesions as compared to standard instruments.
Ethics approval(s)	Comitato etico interaziendale AOU Città della Salute e della Scienza, 26/05/2014, ref: N 531
Health condition(s) or problem(s) studied	1. Colorectal cancer 2. Colorectal adenomas
Intervention	Patients are randomly allocated into two groups, who will each undergo a colonoscopy. For patients in the first group, a standard white light HD endoscope (Standard Forward View) is used, and for patients in the second group, Full Spectrum Endoscopy (FUSE) technology is used. The two instruments are similar, the only difference being related to the characteristics and number of the lenses. The only difference for the patients might be related to the slightly longer duration of the exam with FUSE technology as it may be more likely to find one or more polyps. IN general a colonscopy is expected to last about 30 minutes. No study related follow-up after the completion of the colonoscopic assessment is planned within this study
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	1. Additional yield of advanced adenomas in patients when using Fuse as compared to SFV 2. Proportion of patients detected with 3 or more adenomas when using Fuse as compared to SFV
Key secondary outcome measure(s)	1. Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas detection rate of the two techniques, determined from the information recorded in endoscopist and pathology reports 2. Comparison of the size of multiple lesions detected by the two methods, determined from the information recorded in endoscopist and pathology reports 3. Comparison of the detection rate of neoplasia by colonic site: distal (rectum, sigmoid and descending colon) and proximal (proximal to the descending colon), determined from the information recorded in endoscopist and pathology reports 4. Differences in the surveillance guidelines post-colonoscopy when comparing the two arms, determined from the information recorded in endoscopist and pathology reports 5. Comparison of the time required to reach the cecum, determined from the information recorded in endoscopist and pathology reports 6. Comparison of the withdrawal and total procedure time, determined from the information recorded in endoscopist and pathology reports 7. Assessing the learning curve of participating endoscopists, determined from the information recorded in endoscopist and pathology reports 8. Assessing patient’s experience, measured using a questionnaire administered at the end of the examination 9. Assessing the specific contribution of the additional view estimating the proportion of polyps detected using the additional views only, determined from the information recorded in endoscopist and pathology reports
Completion date	31/12/2015

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	All
Target sample size at registration	700
Key inclusion criteria	Consecutive patients aged 50 to 69 years undergoing their first colonoscopy examination in the participating centers following a positive fecal immunochemical test (FIT) performed in the context of a regional mass-screening program.
Key exclusion criteria	1. Personal history of colorectal cancer or advanced adenoma 2. More than one first degree relative with colorectal cancer 3. Inflammatory bowel disease (IBD) 4. Endoscopy within past 5 years
Date of first enrolment	01/09/2014
Date of final enrolment	15/10/2015

Locations

Countries of recruitment

Italy

Study participating centres

CPO Piemonte and Gastroenterology Unit 2 - AOU Città della Salute e della Scienza

Via S Francesco da Paola 31
Turin
10123
Italy

Ospedale Valduce

Como
22100
Italy

Istituto Clinico Humanitas

Rozzano (Milano)
20089
Italy

Ospedale di Circolo

Rho (Milano)
20017
Italy

Ospedale S Chiara

Trento
38122
Italy

IRCCS Ospedale S. Maria Nuova

Reggio Emilia
42100
Italy

Osepdale Nuovo Regina Margherita

Roma
00100
Italy

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2017		Yes	No

Editorial Notes

04/02/2019: Publication reference added.