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Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease

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ClinicalTrials.gov Identifier: NCT03095573
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
IRCCS Policlinico S. Donato
Information provided by (Responsible Party):
Luca Elli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:
Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune enteropathy in Western countries, and is usually associated with a good response to the gluten free diet and an excellent prognosis. However, a minority of patients develop complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically improved thank to the availability of capsule endoscopy exploration. The aim of this study was to evaluate detection rate and diagnostic concordance of the axial view capsule and CapsoCam capsules in the same patients.

Condition or disease Intervention/treatment Phase
Celiac Disease Device: Lateral-viewing CapsoCam device Device: Axial-viewing capsule Not Applicable

Detailed Description:

The study will involve 25 patients with suspected complicated celiac disease , which for clinical reasons are referred for an evaluation of the small intestine by means of capsule endoscopic in order to screen/identify complications. Furthermore, patients under regular follow-up for a known complication of celiac disease (i.e. refractory celiac disease, ulcerative jejunoileitis) will also be enrolled.

Patients reffered to the Center for Prevention and Diagnosis of celiac disease at the research Hospital "Fondazione Cà Granda Ospedale Maggiore Policlinico" in Milan will be prospectively evaluated and consecutively enrolled in the study.

In agreement with international Guidelines, the diagnosis of celiac disease will be based on Presence of atrophy in the duodenal biopsy sampling (Marsh-Oberhuber type 3) and positive serology or genetic compatibility (in case of seronegative patients at diagnosis).

Patients at high risk of celiac disease complications are defined as

  • subjects older than 50 years at the time of celiac disease diagnosis
  • subjects with persistence / recurrence of gastrointestinal symptoms after at least 6 months of gluten-free diet
  • subjects reporting poor compliance to the gluten-free diet
  • subjects with alarm signs at diagnosis or during follow-up.

All enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another, according to a protocol already validated in terms of security in other studies. The order of administration of the two different capsules, will be determined by a specific randomization sequence.

At the end of the examination, recorded data from the capsules will be acquired according to the following steps:

  • For the axial-view capsule: removal of the recorder after 10 hours recording and/or after checking that the capsule has reached the cecum. The patient will also be instructed to retrieve the capsule from the stools in the hours / days following the examination as per standard protocol.
  • For the lateral-view capsule, the patient will be given a specific kit for its retrieval and conservation. The recorded data will be downloaded after retrieval of the capsule.

The 50 videos will be reviewed by three experts operators (L.E., F.B. G.E.T.), blinded and in randomized order. The operators will evaluate the number of lesions detected by the two different types of capsule system (Primary endpoint) and the mean extension of the lesions detected, expressed as percentage of the total transit time of the capsule in the small intestine (Secondary endpoint)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another. The order of administration of the two different capsules will be determined by a specific randomization sequence.
Masking: Single (Outcomes Assessor)
Masking Description: The videos will be reviewed by three experts operators blinded about the sequence of capsule examination administration
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Comparison Between Axial- and Lateral-viewing Capsule Endoscopy Systems in Celiac Patients: a Pilot Study
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : February 28, 2019


Arm Intervention/treatment
Experimental: Lateral-viewing capsule
Examination of the small bowel by means of the lateral-viewing CapsoCam device
Device: Lateral-viewing CapsoCam device
Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device

Active Comparator: Axial-viewing capsule
Examination of the small bowel by means of the axial-viewing capsule
Device: Axial-viewing capsule
Small bowel capsule endoscopy examination with the Axial-viewing capsule device




Primary Outcome Measures :
  1. Lesions detected [ Time Frame: up to 24 hours, the time of progression of the capsule through the small bowel ]
    Mean number of lesions detected by the two different types of devices, expressed as diagnostic yield and total number of lesions


Secondary Outcome Measures :
  1. Extension of the lesions [ Time Frame: up to 24 hours, the time of progression of the capsule through the small bowel ]
    Mean extension of the lesions detected, expressed as percentage of the total transit time of the capsule in the small intestine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with celiac disease at high risk of complication (see above for a detailed description)

Exclusion Criteria:

  • presence of Pacemaker or Defibrillator
  • suspected small bowel obstruction
  • impaired swallowing
  • pregnancy
  • presence of contraindications to a capsule endoscopy examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095573


Contacts
Contact: Luca Elli, MD, PhD +390255033384 lucelli@yahoo.com
Contact: Federica Branchi, MD +390255033384 federica.branchi@gmail.com

Locations
Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Recruiting
Milano, MI, Italy, 20122
Contact: Luca Elli, MD, PhD    +390255033384    lucelli@yahoo.com   
Sub-Investigator: Federica Branchi, MD         
Sub-Investigator: Francesca Ferretti, MD         
Sub-Investigator: Roberto Penagini, MD, Prof.         
Sub-Investigator: Dario Conte, MD, Prof.         
Irccs Policlinico San Donato Active, not recruiting
San Donato Milanese, MI, Italy, 20097
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IRCCS Policlinico S. Donato
Investigators
Principal Investigator: Luca Elli, MD, PhD Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy

Publications:

Responsible Party: Luca Elli, MD, PhD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT03095573     History of Changes
Other Study ID Numbers: Capsocam
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Luca Elli, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Celiac disease
Enteropathy associated T cell lymphoma
Refractory celiac disease
Small bowel adenocarcinoma

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases