Esophageal Capsule Endoscopy in Children

NCT01551966 | Completed

• 1 other identifier: 2010.644/48
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Portal Hypertension; Cirrhosis

Keywords

Esophageal varices; Portal hypertension in children; Wireless capsule endoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Diagnostic value comparing the specificity, the positive and negative predictive value (PPV, NPV) of the wireless capsule endoscopy

  1 week

• Feasibility and safety of the wireless capsule endoscopy

  4 weeks

• Acceptance of the wireless capsule endoscopy

  1 week

• Applicability of the wireless capsule endoscopy

  1 week

Study Arms (1)

video capsule endoscopy

EXPERIMENTAL

Device: Wireless esophageal capsule endoscopy ( PillCam Eso2)

Interventions

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.

Also known as: PillCam Eso2

video capsule endoscopy

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (7)

Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux

Bordeaux, 33000, France

Location

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

Bron, 69677, France

Location

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

Lille, 59037, France

Location

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

Paris, 75019, France

Location

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

Paris, 75743, France

Location

Service de Pédiatrie, Hôpital Sud, CHU de Rennes

Rennes, 35203, France

Location

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

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 30184608 RESULT

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis; Esophageal and Gastric Varices

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 13, 2012
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 28, 2019

Record last verified: 2013-07

Locations

FR (7)