Clinical trial NCT02826993: Patients With Incomplete Colonoscopy a Comparison of Colon Capsule Endoscopy and CT Colonography
Official title: Can Colon Capsule Endoscopy Substitute CT Colonography in the Large Bowel Examination of Persons Whose Colonoscopy Was Incomplete?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Colonoscopy
CT Colonography
Camera Capsule Endoscopy
Keywords: PillCAM2
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Incomplete colonoscopy

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sensitivity and specificity of CCE compared to CTC
timeFrame: Up to 14 days for conducting both procedures
Secondary outcomes:
measure: Size estimation
timeFrame: Up to 14 days for conducting both procedures
measure: Polyp miss rate
timeFrame: Up to 30 days for conducting all three procedures
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Odense University Hospital, Svendborg Sygehus
Study officials:
affiliation: Odense University Hospital
name: Gunnar Baatrup, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.