Esophageal Capsule Endoscopy in Children

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Portal HypertensionCirrhosis
Interventions
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."

Trial Locations (7)

31059

Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse, Toulouse

33000

Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux, Bordeaux

35203

Service de Pédiatrie, Hôpital Sud, CHU de Rennes, Rennes

59037

Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille, Lille

69677

Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron

75019

Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP, Paris

75743

Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP, Paris

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT01551966 - Esophageal Capsule Endoscopy in Children | Biotech Hunter | Biotech Hunter