Colorectal CancerNCT02812550
Full-spectrum Endoscopy in Colorectal Cancer Screening
A study testing colonoscopy procedure in people with Colorectal Cancer, run by Hospital del Rio Hortega.
Trial summary
The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme. Read more about this study
- Who is it for?
- Ages 50 to 69 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- colonoscopy procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient referred for colorectal cancer screening with positive fecal inmunological test.
- Age between 50 and 69 years
Who cannot join
- history of colonic resection,
- high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome,
- inflammatory bowel disease,
- patients with lower gastrointestinal bleeding symptoms,
- acute diverticulitis,
- colonic strictures,
- poor bowel preparation (Boston scale less than 5 points)
About this study
Official title: Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial
The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.
Read the detailed description
Colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in West countries. Colonoscopy is the gold standard for prevention of colorectal cancer disease. Screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. Colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. Although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. Advanced Technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. Full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population.
The investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. One arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (EndoChoice) (330º angle view)
- Conditions
- Colorectal Cancer
- Being tested
- colonoscopy procedure
- Keywords
- full-spectrum endoscopy, polyp detection rate, colorectal cancer, colorectal screening, adenoma detection rate, endoscopic innovations
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy procedureProcedure or surgery
endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy
| Study group | Role | What they receive |
|---|---|---|
| full-spectrum colonoscopy | Other | Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view) Receives: Procedure: colonoscopy procedure |
| standar forward-viewing colonoscopy | Other | Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view) Receives: Procedure: colonoscopy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate in the two different colonoscopies
number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period.
Measured: one week
Secondary outcomes (8)
time to caecal intubation in each group
time to reach appendicular orifice
Measured: one week
total procedure time in each group
time since the begining of the procedure till is totally finish
Measured: one week
Adverse events
Any inmediatly complication
Measured: one week
advance adenoma rate in each group
10mm or greater in size, villous component or high grade dysplasia
Measured: one week
polyp detection rate in right and left colon in each group
Measured: one week
polyp retrieval rate in each group
proportion of resected polyps that were retrieved and sent for histologically analysis
Measured: one week
caecal intubation rate in each group
proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached
Measured: one week
colonoscopy withdrawal time
average time taken withdraw the colonoscope from the caecal pole to the anus.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mª Henar Núñez Rodriguez, Hospital del Rio Hortega
- Investigators
- Mª Henar Núñez Rodriguez, MD, PhD, Principal investigator, Hospital del Rio Hortega Valladolid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812550
- Sponsor's protocol ID
- GRS 1073/A/15
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nunez-Rodriguez H, Diez-Redondo P, Perez-Miranda M, Gonzalez Sagrado M, Conde R, De la Serna C. Role of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Trial. J Clin Gastroenterol. 2019 Mar;53(3):191-196. doi: 10.1097/MCG.0000000000000975.
PubMed 29283904
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02812550
- Acronym / sponsor ID
- GRS 1073/A/15
- Conditions
- Colorectal Cancer
- Keywords
- full-spectrum endoscopy, polyp detection rate, colorectal cancer, colorectal screening, adenoma detection rate, endoscopic innovations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.
Detailed description
Colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in West countries. Colonoscopy is the gold standard for prevention of colorectal cancer disease. Screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. Colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. Although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. Advanced Technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. Full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population.
The investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. One arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (EndoChoice) (330º angle view)
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| full-spectrum colonoscopy | Other | Procedure: colonoscopy procedureColonoscopy is performed with a full-spectrum colonoscopy (330º angle of view) |
| standar forward-viewing colonoscopy | Other | Procedure: colonoscopy procedureColonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view) |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient referred for colorectal cancer screening with positive fecal inmunological test.
- Age between 50 and 69 years
Key exclusion criteria (7 listed)
- history of colonic resection,
- high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome,
- inflammatory bowel disease,
- patients with lower gastrointestinal bleeding symptoms,
- acute diverticulitis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy procedureendoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy | Procedure or surgery | full-spectrum colonoscopy, standar forward-viewing colonoscopy |
Primary outcome
adenoma detection rate in the two different colonoscopies
Time frame: one week
number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period.
8 secondary outcomes
time to caecal intubation in each group
Time frame: one week
total procedure time in each group
Time frame: one week
Adverse events
Time frame: one week
advance adenoma rate in each group
Time frame: one week
polyp detection rate in right and left colon in each group
Time frame: one week
polyp retrieval rate in each group
Time frame: one week
caecal intubation rate in each group
Time frame: one week
colonoscopy withdrawal time
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 29283904Nunez-Rodriguez H, Diez-Redondo P, Perez-Miranda M, Gonzalez Sagrado M, Conde R, De la Serna C. Role of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Trial. J Clin Gastroenterol. 2019 Mar;53(3):191-196. doi: 10.1097/MCG.0000000000000975.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mª Henar Núñez Rodriguez, MD, PhD principal investigator
Hospital del Rio Hortega Valladolid, Spain
Questions about this trial
What is this clinical trial studying?
A study testing colonoscopy procedure in people with Colorectal Cancer, run by Hospital del Rio Hortega.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adenoma detection rate in the two different colonoscopies (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02812550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.