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Completed

NCT Number: NCT02826993

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

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.

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Key information

Conditions

Incomplete Colonoscopy CT Colonography Camera Capsule Endoscopy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Svendborg Sygehus

Svendborg, 5700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CCE in incomplete Colonoscopies

Device

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

Other names: PillCams2

Primary outcomes

  1. 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

Secondary outcomes

  1. Size estimation

    Time frame: Up to 14 days for conducting both procedures

    Each polyp is estimated in terms of size through the use of both technologies

  2. Polyp miss rate

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Can Colon Capsule Endoscopy Substitute CT Colonography in the Large Bowel Examination of Persons Whose Colonoscopy Was Incomplete?

Acronym: CfC100

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2016
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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