PillCam Colon Capsule and CT-colonography in the Evaluation of Patients With Incomplete Conventional Colonoscopy

NCT01525940 | Completed

• 1 other identifier: CCE-CTC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer (CRC) is the second most common cause of cancer-related death in the Western world, with 500000 deaths per year worldwide. Colonoscopy is accepted as a primary CRC screening tool in many countries. As a preventative procedure, its main purpose is to enable the early diagnosis of CRC at a curable stage and to identify and remove pre-malignant adenomas. Cecal intubation is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. Complete colonic evaluation is therefore a well-recognized measure of colonoscopy quality control. Cecal intubation rates of ≥ 90% of all colonoscopies in routine clinical practice and ≥ 95% in screening colonoscopies are recommended. Unfortunately, the cecal intubation rate in daily clinical practice is often lower than the target of ≥ 90%, with reported percentages varying from 76.9% to 98.4%. This means that after an incomplete colonoscopy, malignant and pre-malignant lesions may be missed if further investigation is not pursued. Several explanatory factors for incomplete colonoscopy have been described. After an incomplete conventional colonoscopy, patients are required to undergo another test to complete the visualization of the colon. Options for incomplete examinations because of anatomic reasons include both radiologic and endoscopic means. CT Colonography (CTC ) permits to visualise the whole colon, is minimally invasive, does not require sedation and is well accepted by the patient. The PillCam Colon Capsule Endoscopy (Given® Diagnostic System)offers an alternative approach for endoscopic visualization of the colon in patients with an incomplete conventional colonoscopy. Advantages of the PillCam Colon Capsule Endoscopy (PCCE) include the elimination of the need for sedation, the minimally invasive, painless nature of the exam, no need of X-rays and the ability to pursue normal daily activities immediately following the procedure. This is a study that is designed to evaluate the performance of the PCCE in the evaluation of patients with an incomplete colonoscopy, compared to the CT-colonography. PCCE and CT-colonography procedures will be compared in regards to completeness of the procedure and detection of lesions in the colon that would have been missed by the incomplete conventional colonoscopy.

Conditions

Colorectal Cancer

Keywords

colon capsule endoscopy; CT-colonography; Patients; incomplete colonoscopy

Outcome Measures

Primary Outcomes (1)

• To evaluate the completeness of colonic exploration in patients with a previous incomplete conventional colonoscopy due to technical failure (not due to inadequate cleansing level).

  12 months

Secondary Outcomes (1)

• To evaluate the difference in terms of accuracy and completeness between PCCE and CT-colonography

  12 months

Study Arms (1)

Colon capsule and CT-colonography

OTHER

PillCam Colon Capsule Endoscopy (Given® Diagnostic System) ingestion first and CT-colonography about 10-12 hours post-ingestion

Device: PillCam Colon Capsule Endoscopy (Given® Diagnostic System)

Interventions

PillCam Colon Capsule Endoscopy (Given® Diagnostic System) DEVICE

2nd-generation CCE is 11.6x31.5 mm size, slightly bigger than previous capsule. It has 2 images with an angle of view increased to 172° degrees for each image. CCE-2 captures 35 images/sec. when in motion and 4 images/sec. when virtually stationary. Capsule battery life is at least 10 hours. The Recorder is an external receiving/recording and transmitting unit that receives data transmitted by the capsule. The portable Recorder consists of an antenna array which attaches to the body, a receiver and memory for accumulation of data during the exam. Data transmission is done via high capacity digital link. Workstation is a modified standard personal computer for reviewing videos generated from images acquired by the capsule, interpretation, analysis of acquired data and generating reports.

Colon capsule and CT-colonography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between the ages of 18-75 years.
• Subject is referred for colonoscopy as clinically indicated for any reason. This may include, but not limited to, the investigation of any of the following conditions: rectal bleeding, melena, positive stool testing for occult blood, recent change of bowel habits, screening for colorectal cancer, colonic findings on an imaging study
• Subject in which conventional colonoscopy was incomplete

You may not qualify if:

• Subject has dysphagia or any swallowing disorder
• Subject has Congestive heart failure
• Subject has high degree of renal insufficiency
• Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator
• Subject has a cardiac pacemaker or other implanted electromedical device.
• Subject has any allergy or other known contraindication to the medications used in the study
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, or NSAID enteropathy,
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child bearing potential and do not practice medically acceptable methods of contraception
• Subject suffers from life threatening conditions
• Subject currently participating in another clinical study
• Iodine contrast allergy
• Hyperthyroidism
• Inflammatory bowel disease

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of Sacred Hearth

Rome, Italy, 00168, Italy

Location

Related Publications (1)

• Spada C, Hassan C, Barbaro B, Iafrate F, Cesaro P, Petruzziello L, Minelli Grazioli L, Senore C, Brizi G, Costamagna I, Alvaro G, Iannitti M, Salsano M, Ciolina M, Laghi A, Bonomo L, Costamagna G. Colon capsule versus CT colonography in patients with incomplete colonoscopy: a prospective, comparative trial. Gut. 2015 Feb;64(2):272-81. doi: 10.1136/gutjnl-2013-306550. Epub 2014 Jun 24.

  PMID: 24964317 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Guido Costamagna, Professor

  Catholic University Sacred Heart, Rome Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 3, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

IT (1)