- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03095573
Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease
Prospective Randomized Comparison Between Axial- and Lateral-viewing Capsule Endoscopy Systems in Celiac Patients: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luca Elli, MD, PhD
- Phone Number: +390255033384
- Email: lucelli@yahoo.com
Study Contact Backup
- Name: Federica Branchi, MD
- Phone Number: +390255033384
- Email: federica.branchi@gmail.com
Study Locations
-
-
MI
-
Milano, MI, Italy, 20122
- Recruiting
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
-
Contact:
- Luca Elli, MD, PhD
- Phone Number: +390255033384
- Email: lucelli@yahoo.com
-
Sub-Investigator:
- Roberto Penagini, MD, Prof.
-
Sub-Investigator:
- Dario Conte, MD, Prof.
-
San Donato Milanese, MI, Italy, 20097
- Active, not recruiting
- IRCCS Policlinico San Donato
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lateral-viewing capsule
Examination of the small bowel by means of the 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
|
Small bowel capsule endoscopy examination with the Axial-viewing capsule device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 24 hours, the time of progression of the capsule through the small bowel
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 24 hours, the time of progression of the capsule through the small bowel
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Luca Elli, MD, PhD, Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy
Publications and helpful links
General Publications
- Volta U, Bellentani S, Bianchi FB, Brandi G, De Franceschi L, Miglioli L, Granito A, Balli F, Tiribelli C. High prevalence of celiac disease in Italian general population. Dig Dis Sci. 2001 Jul;46(7):1500-5. doi: 10.1023/a:1010648122797.
- Green PH, Fleischauer AT, Bhagat G, Goyal R, Jabri B, Neugut AI. Risk of malignancy in patients with celiac disease. Am J Med. 2003 Aug 15;115(3):191-5. doi: 10.1016/s0002-9343(03)00302-4.
- Catassi C, Bearzi I, Holmes GK. Association of celiac disease and intestinal lymphomas and other cancers. Gastroenterology. 2005 Apr;128(4 Suppl 1):S79-86. doi: 10.1053/j.gastro.2005.02.027.
- Culliford A, Daly J, Diamond B, Rubin M, Green PH. The value of wireless capsule endoscopy in patients with complicated celiac disease. Gastrointest Endosc. 2005 Jul;62(1):55-61. doi: 10.1016/s0016-5107(05)01566-x.
- Daum S, Wahnschaffe U, Glasenapp R, Borchert M, Ullrich R, Zeitz M, Faiss S. Capsule endoscopy in refractory celiac disease. Endoscopy. 2007 May;39(5):455-8. doi: 10.1055/s-2007-966239. Erratum In: Endoscopy. 2007 Jul;39(7):672. Endoscopy. 2007 May;39(5):1 p following 458.
- Rondonotti E, Spada C, Cave D, Pennazio M, Riccioni ME, De Vitis I, Schneider D, Sprujevnik T, Villa F, Langelier J, Arrigoni A, Costamagna G, de Franchis R. Video capsule enteroscopy in the diagnosis of celiac disease: a multicenter study. Am J Gastroenterol. 2007 Aug;102(8):1624-31. doi: 10.1111/j.1572-0241.2007.01238.x. Epub 2007 Apr 24.
- Rostom A, Murray JA, Kagnoff MF. American Gastroenterological Association (AGA) Institute technical review on the diagnosis and management of celiac disease. Gastroenterology. 2006 Dec;131(6):1981-2002. doi: 10.1053/j.gastro.2006.10.004. No abstract available.
- Rondonotti E, Soncini M, Girelli C, Ballardini G, Bianchi G, Brunati S, Centenara L, Cesari P, Cortelezzi C, Curioni S, Gozzini C, Gullotta R, Lazzaroni M, Maino M, Mandelli G, Mantovani N, Morandi E, Pansoni C, Piubello W, Putignano R, Schalling R, Tatarella M, Villa F, Vitagliano P, Russo A, Conte D, Masci E, de Franchis R; AIGO, SIED and SIGE Lombardia. Small bowel capsule endoscopy in clinical practice: a multicenter 7-year survey. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1380-6. doi: 10.1097/MEG.0b013e3283352ced.
- Bardella MT, Elli L, De Matteis S, Floriani I, Torri V, Piodi L. Autoimmune disorders in patients affected by celiac sprue and inflammatory bowel disease. Ann Med. 2009;41(2):139-43. doi: 10.1080/07853890802378817.
- Leighton JA. The role of endoscopic imaging of the small bowel in clinical practice. Am J Gastroenterol. 2011 Jan;106(1):27-36; quiz 37. doi: 10.1038/ajg.2010.410. Epub 2010 Oct 26.
- Pioche M, Vanbiervliet G, Jacob P, Duburque C, Gincul R, Filoche B, Daudet J, Filippi J, Saurin JC; French Society of Digestive Endoscopy (SFED). Prospective randomized comparison between axial- and lateral-viewing capsule endoscopy systems in patients with obscure digestive bleeding. Endoscopy. 2014 Jun;46(6):479-84. doi: 10.1055/s-0033-1358832. Epub 2013 Nov 27.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Capsocam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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