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

Celiac Disease Clinical Trial

Official title:

Prospective Randomized Comparison Between Axial- and Lateral-viewing Capsule Endoscopy Systems in Celiac Patients: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03095573
• Other study ID #: Capsocam
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 29, 2017
• Start date: March 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2017
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: Luca Elli, MD, PhD
• Phone: +390255033384
• Email: lucelli[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 28, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Device:
• Lateral-viewing CapsoCam device
Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device
• Axial-viewing capsule
Small bowel capsule endoscopy examination with the Axial-viewing capsule device

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	MI
Italy	Irccs Policlinico San Donato	San Donato Milanese	MI

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Erratum in: Endoscopy. 2007 Jul;39(7):672.. Endoscopy. 2007 May;39(5):1 p following 458. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesions detected	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	Extension of the lesions	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