Esophageal Capsule Endoscopy in Children
- Conditions
- Portal HypertensionCirrhosis
- Interventions
- Device: Wireless esophageal capsule endoscopy ( PillCam Eso2)
- Registration Number
- NCT01551966
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description video capsule endoscopy Wireless esophageal capsule endoscopy ( PillCam Eso2) -
- Primary Outcome Measures
Name Time Method Diagnostic value of the wireless capsule endoscopy 1 week 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.
- Secondary Outcome Measures
Name Time Method Feasibility and safety of the wireless capsule endoscopy 4 weeks 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.
Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy 1 week 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.
Applicability of the wireless capsule endoscopy 1 week 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.
Acceptance of the wireless capsule endoscopy 1 week Acceptance of the wireless capsule endoscopy by the patient compared to the EGD under general sedation by calculating a comfort score.
Trial Locations
- Locations (7)
Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
🇫🇷Paris Cedex 15, 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 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
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, France