Clinical trial NCT01551966: Esophageal Capsule Endoscopy in Children
Official title: Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portal Hypertension
Cirrhosis
Keywords: Esophageal varices
Portal hypertension in children
Wireless capsule endoscopy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic value of the wireless capsule endoscopy
timeFrame: 1 week
Secondary outcomes:
measure: Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy
timeFrame: 1 week
measure: Feasibility and safety of the wireless capsule endoscopy
timeFrame: 4 weeks
measure: Acceptance of the wireless capsule endoscopy
timeFrame: 1 week
measure: Applicability of the wireless capsule endoscopy
timeFrame: 1 week
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux
city: Bron
country: France
facility: Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
city: Lille
country: France
facility: Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille
city: Paris Cedex 15
country: France
facility: Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
city: Paris
country: France
facility: Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP
city: Rennes
country: France
facility: Service de Pédiatrie, Hôpital Sud, CHU de Rennes
city: Toulouse Cedex 9
country: France
facility: Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse
Study officials:
References:
citation: 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. Endoscopy. 2019 Jan;51(1):10-17. doi: 10.1055/a-0647-1709. Epub 2018 Sep 5.