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Completed

NCT Number: NCT01551966

Esophageal Capsule Endoscopy 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.

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Key information

Conditions

Portal Hypertension Cirrhosis Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wireless esophageal capsule endoscopy ( PillCam Eso2)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children

Acronym: PREVOCAP

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2012
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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