Patients With Incomplete Colonoscopy a Comparison of Colon Capsule Endoscopy and CT Colonography

Not Applicable

Completed

• Conditions: Camera Capsule Endoscopy; Incomplete Colonoscopy; CT Colonography
• Interventions: Device: CCE in incomplete Colonoscopies

• Registration Number: NCT02826993
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study First Submitted: 2016-05-20
• Study Start: 2016-06
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Status Verified: 2018-08
• Primary Completion: 2019-04-01
• Study Completion: 2019-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Incomplete colonoscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCE in incomplete Colonoscopies	CCE in incomplete Colonoscopies	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of CCE compared to CTC	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

Secondary Outcome Measures

Name	Time	Method
Polyp miss rate	Up to 30 days for conducting all three procedures	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)
Size estimation	Up to 14 days for conducting both procedures	Each polyp is estimated in terms of size through the use of both technologies

Trial Locations

Locations (1)

Odense University Hospital, Svendborg Sygehus; 🇩🇰 Svendborg, Denmark