Clinical trial NCT03095573: Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease
Official title: Prospective Randomized Comparison Between Axial- and Lateral-viewing Capsule Endoscopy Systems in Celiac Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Celiac Disease
Keywords: Celiac disease
Enteropathy associated T cell lymphoma
Refractory celiac disease
Small bowel adenocarcinoma
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: IRCCS Policlinico S. Donato
First posted: 2017-03-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: DIAGNOSTIC

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.

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)

Eligibility 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

Primary outcomes:
measure: Lesions detected
timeFrame: up to 24 hours, the time of progression of the capsule through the small bowel
Secondary outcomes:
measure: Extension of the lesions
timeFrame: up to 24 hours, the time of progression of the capsule through the small bowel
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: MI
city: San Donato Milanese
country: Italy
facility: Irccs Policlinico San Donato
state: MI
Study officials:
affiliation: Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy
name: Luca Elli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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