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

March 8, 2012
July 26, 2013
October 2011
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01551966 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Esophageal Capsule Endoscopy in Children
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Portal Hypertension
  • Cirrhosis
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
Experimental: video capsule endoscopy
Intervention: Device: Wireless esophageal capsule endoscopy ( PillCam Eso2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
7 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01551966
2010.644/48
No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Not Provided
Hospices Civils de Lyon
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP