Esophageal Capsule Endoscopy in Children

Cirrhosis Clinical Trial

— PREVOCAP  

Official title:

Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551966
• Other study ID #: 2010.644/48
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The portal hypertension (PHT) is the main complication in patients presenting with cirrhosis. It can be the direct cause of bleeding by rupture of the esophageal or gastric varices and can also contribute to the development of ascites, hepatic encephalopathy and pleuropulmonary complications.

In the paediatric population presenting with the PHT, one of every two children develops varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule endoscopy (VCE) is now routinely used in children for the exploration of the small bowel. But the role of the VCE for examination of the other parts of digestive tract still needs to be evaluated.

For the esophagus, the VCE could allow the diagnosis without the need of general sedation. Recent studies have shown a good sensitivity and tolerance of this technique for the initial diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension, but it has not yet been validated for this indication.

The investigators hypothesize that the VCE could be used in children with similar results in term of efficacy, as for adults.

This prospective simple blind multicentre study (blind for the lecture of the capsule endoscopy record), will investigate the diagnostic value of the VCE compared to the conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and the control of esophageal varices in children.

If it is provided that the VCE is as efficient as it is for the adults, it could become a very interesting alternative to the conventional EGD because less expensive and less invasive. Moreover, this technique would be very useful as a means of early detection on the EV and/or their control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• patients between 7 and 18 years old

• presenting a portal hypertension and/or cirrhosis

• patients who are referred for a conventional EGD under general sedation

• patients who are not participating in other clinical studies

• written informed consent obtained from the patient and his/her legal guardians.

Exclusion Criteria:

• patients presenting a contra indication for upper endoscopy or for the ingestion of the video capsule, especially those with clinical or radiological suspicion of upper gastrointestinal strictures (esophageal surgery or eosinophile esophagitys)

• patients presenting with dysphagia or gastrointestinal tract strictures (patients with Crohn's disease, small bowel carcinoma, stenosis due to the chronic use of a NSAI medication, acute necrotizing enterocolitis or prior abdominal surgery of the gastrointestinal tract); swallowing disorders with or without impaired consciousness;

• patients under calcium channel blocking agents medication;

• patient presenting with diverticulosis (Marphan's or Ehlers Danlos's syndrome)

• patients with cardiac pacemaker or other implanted electro medical device

• patients scheduled for a magnetic resonance imaging (MRI) examination within 7 days after ingestion of the capsule (and until the capsule is evacuated)

• any other life-threatening conditions.

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Hypertension
• Hypertension, Portal
• Portal Hypertension

Intervention

Device:
• Wireless esophageal capsule endoscopy ( PillCam Eso2)
This is a simple blind (blind for the lecture of the capsule endoscopy record) study to evaluate the diagnostic value of the capsule endoscopy for the detection and the control of esophageal varices, the feasibility, tolerance and safety of the capsule endoscopy compared to the conventional EGD under general sedation in children presenting with portal hypertension. During one week, the patients will undergo two exams (capsule endoscopy and EGD under general sedation). The exams will be done by two different physicians. For to asses the tolerance, after they completed both exams, the patients will be asked to answer a "comfort score" questionnaire. In order to asses the safety of the capsule endoscopy, the patients will be followed for adverse events during 3 weeks after the completion of the capsule endoscopy.

Locations

Country	Name	City	State
France	Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux	Bordeaux
France	Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon	Bron
France	Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille	Lille
France	Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP	Paris
France	Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP	Paris Cedex 15
France	Service de Pédiatrie, Hôpital Sud, CHU de Rennes	Rennes
France	Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Cardey J, Le Gall C, Michaud L, Dabadie A, Talbotec C, Bellaiche M, Lamireau T, Mas E, Bridoux-Henno L, Viala J, Restier-Miron L, Lachaux A. Screening of esophageal varices in children using esophageal capsule endoscopy: a multicenter prospective study. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value of the wireless capsule endoscopy	The diagnostic value of the wireless capsule endoscopy as measured by the sensitivity of the wireless capsule endoscopy for the detection and the control of esophageal varices in children compared to the EGD sensitivity.	1 week
Secondary	Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy	Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy with the results for the EGD under general sedation.	1 week
Secondary	Feasibility and safety of the wireless capsule endoscopy	Feasibility and safety of the wireless capsule endoscopy compared to the conventional EGD under general sedation as expressed by the safe completion of the wireless capsule endoscopy.	4 weeks
Secondary	Acceptance of the wireless capsule endoscopy	Acceptance of the wireless capsule endoscopy by the patient compared to the EGD under general sedation by calculating a comfort score.	1 week
Secondary	Applicability of the wireless capsule endoscopy	Applicability of the wireless capsule endoscopy by evaluating the ability to detect the esophageal or fundic varices, the presence of a portal hypertension gastropathy and the classification of the esophageal varices compared to the EGD results.	1 week