Esophageal Capsule Endoscopy in Children (PREVOCAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01551966|
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : May 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Portal Hypertension Cirrhosis||Device: Wireless esophageal capsule endoscopy ( PillCam Eso2)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
|Experimental: video capsule endoscopy||
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.
Other Name: PillCam Eso2
- Diagnostic value of the wireless capsule endoscopy [ Time Frame: 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.
- Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy [ Time Frame: 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.
- Feasibility and safety of the wireless capsule endoscopy [ Time Frame: 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.
- Acceptance of the wireless capsule endoscopy [ Time Frame: 1 week ]Acceptance of the wireless capsule endoscopy by the patient compared to the EGD under general sedation by calculating a comfort score.
- Applicability of the wireless capsule endoscopy [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551966
|Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux|
|Bordeaux, France, 33000|
|Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon|
|Bron, France, 69677|
|Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille|
|Lille, France, 59037|
|Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP|
|Paris Cedex 15, France, 75743|
|Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP|
|Paris, France, 75019|
|Service de Pédiatrie, Hôpital Sud, CHU de Rennes|
|Rennes, France, 35203|
|Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse|
|Toulouse Cedex 9, France, 31059|