Cirrhosis Clinical Trial
Official title:
Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children
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.
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