Incomplete ColonoscopyCfC100NCT02826993
Patients With Incomplete Colonoscopy a Comparison of Colon Capsule Endoscopy and CT Colonography
A study testing CCE in incomplete Colonoscopies in people with Incomplete Colonoscopy and CT Colonography, run by Odense University Hospital at 1 site in Denmark.
Trial summary
A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5% and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons. The current standard procedure is to refer the patient to the department of radiology for a CT-colonography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Incomplete Colonoscopy, CT Colonography, Camera Capsule Endoscopy
- What is being tested?
- CCE in incomplete Colonoscopies
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Incomplete colonoscopy
Who cannot join
- Previous gastrointestinal surgery except for appendectomy
- Known inflammatory bowel disease including Crohn's disease and ulcerative colitis
- An ostomy
- Diabetes
- Symptoms on bowel obstruction
- Pacemakers
- Kidney diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Colon Capsule Endoscopy Substitute CT Colonography in the Large Bowel Examination of Persons Whose Colonoscopy Was Incomplete?
A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5% and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons. The current standard procedure is to refer the patient to the department of radiology for a CT-colonography. In some instances the radiology department can offer the investigation the next day, and thus in the same colon preparation. At other times they cannot, and the patient has to go through an second colon preparation for the colonography.
A CCE procedure could be provided to the participants immediately after the failed colonoscopy and the investigation can be completed the next morning in the same bowel preparation without a visit to the radiology department.
Read the detailed description
Optical colonoscopy is the standard method for evaluating the colon. This technique allows evaluation of the entire colon in most patients. Full colonoscopy including examination of the cecum is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. After an incomplete optical colonoscopy, participants are required to undergo another test in order to exclude clinically relevant lesions to reduce the risk of proximal cancer which has been shown to increase by twofold when colonoscopy was incomplete.
Endoscopic and radiological options to complete the colon assessment have been available in the last decades. Multiple alternative endoscopic techniques-such as colonoscopy with thinner colonoscopes, gastroscopes and device-assisted enteroscopes have been described. However, none of them has been clearly standardized.
CT colonography (CTC), is a relatively new imaging technique that was first described in 1994. In large randomized trials on symptomatic patients, CTC has been shown to be as equally effective as colonoscopy - for the detection of large colorectal polyps and already developed colorectal cancer.
Colon Capsule Endoscopy (CCE) is a promising new technology that may have the potential to complement existing diagnostic methods to screen people for colorectal cancer. Delivered correctly, it may reduce costs, increase utilization of medical services, reduce risks for patients and overall improve screening rates among the population.
A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island and about 10% of those are incomplete due to excessive pain, fixed colon loops, and others causes. The current standard procedure is to refer the participant to the Department of Radiology for a CT-colonography.
- Being tested
- CCE in incomplete Colonoscopies
- Keywords
- PillCAM2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCE in incomplete ColonoscopiesDevice
Also called PillCams2
When the initial colonoscopy has failed, participants are invited to ingest a CCE on the day prior to their subsequent CT colonography. Thus, the CCE and CT will be compared within subjects for their ability to identify and estimate sizes of polyps
| Study group | Role | What they receive |
|---|---|---|
| CCE in incomplete Colonoscopies | Experimental | Patients in which colonoscopy is not possible are invited for CT colonography and those patients are examined by Camera Capsule Endoscopy the day before the CT colonography and the two different examinations are compared. Receives: Device: CCE in incomplete Colonoscopies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of CCE compared to CTC
The sensitivity and specificity of CCE will be measured in terms of n of polyps detected by CCE compared to n of polyps detected by CTC
Measured: Up to 14 days for conducting both procedures
Secondary outcomes (2)
Size estimation
Each polyp is estimated in terms of size through the use of both technologies
Measured: Up to 14 days for conducting both procedures
Polyp miss rate
The rate of polyps missed by CCE and CTC respectively compared to a colonoscopy that will be performed in full sedation for participants in whom discrepancy is found between the two modalities (CCE and CTC)
Measured: Up to 30 days for conducting all three procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion1 Apr 2019
- Study completionSep 2019
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 Incomplete ColonoscopyStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Kobaek-Larsen, Odense University Hospital
- Investigators
- Gunnar Baatrup, Professor, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826993
- Sponsor's protocol ID
- OdenseUH_MKL1
- Acronym
- CfC100
- Status last verified
- Aug 2018
- First submitted
- 20 May 2016
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Deding U, Herp J, Havshoei AL, Kobaek-Larsen M, Buijs MM, Nadimi ES, Baatrup G. Colon capsule endoscopy versus CT colonography after incomplete colonoscopy. Application of artificial intelligence algorithms to identify complete colonic investigations. United European Gastroenterol J. 2020 Aug;8(7):782-789. doi: 10.1177/2050640620937593.
PubMed 32731841
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Colon Capsule Endoscopy Substitute CT Colonography in the Large Bowel Examination of Persons Whose Colonoscopy Was Incomplete?
- ClinicalTrials.gov ID
- NCT02826993
- Acronym / sponsor ID
- CfC100 / OdenseUH_MKL1
- Keywords
- PillCAM2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 11 Jul 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.
A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5% and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons. The current standard procedure is to refer the patient to the department of radiology for a CT-colonography. In some instances the radiology department can offer the investigation the next day, and thus in the same colon preparation. At other times they cannot, and the patient has to go through an second colon preparation for the colonography.
A CCE procedure could be provided to the participants immediately after the failed colonoscopy and the investigation can be completed the next morning in the same bowel preparation without a visit to the radiology department.
Detailed description
Optical colonoscopy is the standard method for evaluating the colon. This technique allows evaluation of the entire colon in most patients. Full colonoscopy including examination of the cecum is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. After an incomplete optical colonoscopy, participants are required to undergo another test in order to exclude clinically relevant lesions to reduce the risk of proximal cancer which has been shown to increase by twofold when colonoscopy was incomplete.
Endoscopic and radiological options to complete the colon assessment have been available in the last decades. Multiple alternative endoscopic techniques-such as colonoscopy with thinner colonoscopes, gastroscopes and device-assisted enteroscopes have been described. However, none of them has been clearly standardized.
CT colonography (CTC), is a relatively new imaging technique that was first described in 1994. In large randomized trials on symptomatic patients, CTC has been shown to be as equally effective as colonoscopy - for the detection of large colorectal polyps and already developed colorectal cancer.
Colon Capsule Endoscopy (CCE) is a promising new technology that may have the potential to complement existing diagnostic methods to screen people for colorectal cancer. Delivered correctly, it may reduce costs, increase utilization of medical services, reduce risks for patients and overall improve screening rates among the population.
A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island and about 10% of those are incomplete due to excessive pain, fixed colon loops, and others causes. The current standard procedure is to refer the participant to the Department of Radiology for a CT-colonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCE in incomplete Colonoscopies | Experimental | Device: CCE in incomplete ColonoscopiesPatients in which colonoscopy is not possible are invited for CT colonography and those patients are examined by Camera Capsule Endoscopy the day before the CT colonography and the two different examinations are compared. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Incomplete colonoscopy
Key exclusion criteria (7 listed)
- Previous gastrointestinal surgery except for appendectomy
- Known inflammatory bowel disease including Crohn's disease and ulcerative colitis
- An ostomy
- Diabetes
- Symptoms on bowel obstruction
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 |
|---|---|---|
| CCE in incomplete ColonoscopiesAlso: PillCams2When the initial colonoscopy has failed, participants are invited to ingest a CCE on the day prior to their subsequent CT colonography. Thus, the CCE and CT will be compared within subjects for their ability to identify and estimate sizes of polyps | Device | CCE in incomplete Colonoscopies |
Primary outcome
Sensitivity and specificity of CCE compared to CTC
Time frame: Up to 14 days for conducting both procedures
The sensitivity and specificity of CCE will be measured in terms of n of polyps detected by CCE compared to n of polyps detected by CTC
2 secondary outcomes
Size estimation
Time frame: Up to 14 days for conducting both procedures
Polyp miss rate
Time frame: Up to 30 days for conducting all three procedures
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 10 Sep 2021.
- Derived from this study: PubMed 32731841Deding U, Herp J, Havshoei AL, Kobaek-Larsen M, Buijs MM, Nadimi ES, Baatrup G. Colon capsule endoscopy versus CT colonography after incomplete colonoscopy. Application of artificial intelligence algorithms to identify complete colonic investigations. United European Gastroenterol J. 2020 Aug;8(7):782-789. doi: 10.1177/2050640620937593.
- Individual participant dataSharing planned: Undecided
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.
Gunnar Baatrup, Professor principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCE in incomplete Colonoscopies in people with Incomplete Colonoscopy and CT Colonography, run by Odense University Hospital at 1 site in Denmark.
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 1 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 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Sensitivity and specificity of CCE compared to CTC (time frame: Up to 14 days for conducting both procedures). 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 NCT02826993, 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 10 Sep 2021.