Esophageal Capsule Endoscopy in Children (PREVOCAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01551966
First received: March 8, 2012
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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 Intervention
Portal Hypertension
Cirrhosis
Device: Wireless esophageal capsule endoscopy ( PillCam Eso2)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Diagnostic value of the wireless capsule endoscopy [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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:
  • Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 100
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551966

Locations
France
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 Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP
Paris, France, 75019
Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
Paris Cedex 15, France, 75743
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
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01551966     History of Changes
Other Study ID Numbers: 2010.644/48
Study First Received: March 8, 2012
Last Updated: July 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Esophageal varices
Portal hypertension in children
Wireless capsule endoscopy

Additional relevant MeSH terms:
Hypertension
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014