Esophageal Capsule Endoscopy in Children (PREVOCAP)

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Portal Hypertension
• Intervention / Treatment: Device: Wireless esophageal capsule endoscopy ( PillCam Eso2)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux
  • Bron, France, 69677
    • Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
  • Lille, France, 59037
    • Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille
  • Paris, France, 75019
    • Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP
  • Paris Cedex 15, France, 75743
    • Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
  • Rennes, France, 35203
    • Service de Pédiatrie, Hôpital Sud, CHU de Rennes
  • Toulouse Cedex 9, France, 31059
    • Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: PillCam Eso2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic value of the wireless capsule endoscopy	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy	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.	1 week
Feasibility and safety of the wireless capsule endoscopy	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.	4 weeks
Acceptance of the wireless capsule endoscopy	Acceptance of the wireless capsule endoscopy by the patient compared to the EGD under general sedation by calculating a comfort score.	1 week
Applicability of the wireless capsule endoscopy	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.	1 week

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: March 8, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Esophageal varices; Wireless capsule endoscopy; Portal hypertension in children
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Hypertension, Portal
• Other Study ID Numbers: 2010.644/48