Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's A Pilot Study

Colonic Capsule Endoscopy (CCE) for Screening of Neoplasm's

The primary aim is to evaluate the efficiency of capsule endoscopy (CCE) in in the detection of neoplasms compared to conventional colonoscopy in persons participating in the Danish screening program for colorectal cancer with a positive fecal occult blood with the colonoscopy being the gold standard.

Study Overview

• Status: Completed
• Conditions: Rectal Bleeding
• Intervention / Treatment: Device: Pillcam® COLON Capsule

Detailed Description

Participants will be recruited from the screening program, and are living on the main island of Funen. Persons with a positive FOBT who have been offered and have accepted a colonoscopy will be contacted by telephone and informed about the project by the project nurse.

The persons who accept participation and meet the inclusion criteria will be contacted by the study nurse for scheduling the capsule endoscopy according to the planned colonoscopy, which has to bee within 9-13 days after the result of the FOBT test.

The nurse will instruct the person to take the standard colon preparation 2 days before the colonoscopy, and stay from solid food until after the colonoscopy has been performed according to standard procedure. Thus the period with food-restrictions has to be extended by one day. A visit by the home services nurse the day before the colonoscopy will be arranged. The nurse will assist and supervise the intake of the video capsule and assists with the attachment of the monitor in a belt around the person's belly. Afterwards the questionnaire 1 (appendix 1) will be fulfilled by the patient with assistance from the nurse.

When the capsule has passed anus the monitoring equipment must be disarmed by the patient and stored according to the instructions. The patient will bring the recorder to the hospital the following day and deliver it to the study nurse, who will take care of data-transmission to the institute in Hamburg. After the colonoscopy and recovery period, the patient and the project nurse will fulfill the 2. questionnaire (appendix 2) and the colonoscopist will fulfill a standard report on the findings and treatment at colonoscopy (appendix 3), which will be added to the electronic database by the project secretary. The results form the colonoscopy will be the only information, that will be retrieved form the patients record.

Trained specialists in the Diagnostic Centre in Hamburg will perform the evaluation of the CCE and the data will be entered in a standard diagnostic report (appendix 4). The Diagnostic Centre will not have access to the results of the colonoscopy.

The CCE report must be available within 3 days, and the project responsible will evaluate the result according to the reported findings at colonoscopy. Any disagreement will be evaluated and discussed with the patient. In case of significant disagreement defined as a neoplasms of > 9 mm found at CCE and not detected by colonoscopy the patient will be offered additional diagnostics in the form of repeated colonoscopy within 2 weeks or a CT colonography upon the decision by the patient.

Participants have to stay on a fluid diet for one day more than for the conventional investigation. This might be uncomfortable for some patients, but is without any health-related risk. Another side effect could be increased fecal content in the bowel at colonoscopy due to the extended time from bowel preparation to colonoscopy. In some cases this could result in an incomplete colonscopy, which then has to be repeated. The risk of this side effect is unknown but is considered to be below 5%.

The most significant complication to the CCE will be the risk of impaction of the capsule within the intestine, which may lead to surgery. The risk is minimized by the exclusion criteria and according to daily clinical experience the risk will be less than 0.5%, and will mainly occur in persons with an unknown intestinal pathology, which in the majority of the cases would necessitate surgical treatment anyway. There is no known risk with the monitoring equipment.

In the case of significant disagreement between the results form capsule endoscopy and the conventional colonoscopy the patient may risk further investigations, but on the other hand this could be an advantage for the patients in case of missed lesions at the colonoscopy. The risk of missing cancer or large polyps by colonoscopy is in the range of 1-2%.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odesne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Positive feaecal occult bleeding test at screening

Exclusion Criteria:

• Previous gastrointestinal surgery except for appendectomy
• Known inflammatory bowel disease including Chrohn's disease and ulcerative colitis
• An ostomy
• Symptoms on bowel obstruction (recurrent abdominal pain, constipation or vomiting within the last 3 months)
• Vomiting in connection with the bowel emptying procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pillcam® COLON Capsule; Detection of neoplastic lesions in colon and rectum compared to colonoscopy	Device: Pillcam® COLON Capsule; colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of neoplasia	Compared to colonoscopy	One week after examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate	Documented capsule excretion on the viedorecordin	24 hours

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Investigators: Principal Investigator: Niels Qvist, Professor, Odense University Hospital

Publications and helpful links

General Publications

• Buijs MM, Kroijer R, Kobaek-Larsen M, Spada C, Fernandez-Urien I, Steele RJ, Baatrup G. Intra and inter-observer agreement on polyp detection in colon capsule endoscopy evaluations. United European Gastroenterol J. 2018 Dec;6(10):1563-1568. doi: 10.1177/2050640618798182. Epub 2018 Sep 11.
• Buijs MM, Kobaek-Larsen M, Kaalby L, Baatrup G. Can coffee or chewing gum decrease transit times in Colon capsule endoscopy? A randomized controlled trial. BMC Gastroenterol. 2018 Jun 25;18(1):95. doi: 10.1186/s12876-018-0824-9.
• Blanes-Vidal V, Nadimi ES, Buijs MM, Baatrup G. Capsule endoscopy vs. colonoscopy vs. histopathology in colorectal cancer screening: matched analyses of polyp size, morphology, and location estimates. Int J Colorectal Dis. 2018 Sep;33(9):1309-1312. doi: 10.1007/s00384-018-3064-0. Epub 2018 May 1.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: S-20140141