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Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children

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ClinicalTrials.gov Identifier: NCT00367159
Recruitment Status : Recruiting
First Posted : August 22, 2006
Last Update Posted : February 25, 2009
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Brief Summary:
Urinary tract infection (UTI) is a common problem in childhood associated with vesico-renal reflux (VRR) in 25-40% of children. A persistent VRR and repeated pyelonephritis may predispose to renal scarring and chronic renal failure with an end-stage renal failure in up to 3% of children.Defining a standard behaviour facing VRR in children is not easy because of the lack of reliable evidence. Numbers of studies compare prospectively or retrospectively, medical, endoscopical and surgical treatment.Surgical techniques are effective but invasive and not free of complication. Medical treatment is submissive to a good observance. The introduction of endoscopic techniques permits to prevent UTI and new renal failure by VRR elimination. Since the beginning of the endoscopic treatment, several bulking agents have been proposed. The ideal agent should be easy to inject, stable in time and should be safe. Of course it should be at least as efficient as actual bulking agent. The use of Teflon was the first wave of success of endoscopic treatment. But sudden passion of Teflon has been darkened by the notion of migration. Since, others substances have been proposed, autologous or exogenous, resorbable or not. But none was ideal and no solutions were found facing problem of biocompatibility or long-term stability.Using adipose tissue as a bulking agent is ancient in plastic surgery and indications had known a leap forward in the last century with Coleman who introduced a new technique called "lipostructure". This technique has known a growing interest in the restoration of all volume defects in plastic surgery because of the stability of the graft. We propose to apply this technique to VRR management in children in order to combine innocuousness and efficiency.

Condition or disease Intervention/treatment Phase
Vesico-Ureteral Reflux Procedure: endoscopic treatment of vesico-renal reflux Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children
Study Start Date : January 2007
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy GERD


Intervention Details:
  • Procedure: endoscopic treatment of vesico-renal reflux
    Autologous Adipocytes Graft (lipostructure)


Primary Outcome Measures :
  1. Realization of an urethrocystography [ Time Frame: at 3 months and 1 year ]

Secondary Outcome Measures :
  1. Clinical or biological diagnosis of a pyelonephritis during the follow up (10 years) [ Time Frame: Day 1; Month 1; Month 3 ; Year 1; Year 5 and Year 10 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • sexe : male and female
  • age : 3 to 15 years
  • written consent
  • Vesico-renal reflux staged I to III revealed by a pyelonephritis ; after failure of medical treatment or parent refusal of medical treatment or initial renal failure.

Exclusion criteria :

  • Before 3 years or older than 15 years
  • insulino-dépendant diabet
  • neurologic bladder
  • abnormalities of the urinary tract
  • kidney transplantation
  • past history of bladder surgery
  • anorexia (BMI <12)
  • Vesico-renal reflux staged IV or V
  • Active urinary tract infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367159


Contacts
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Contact: François BECMEUR, MD 33.3.88.12.73.13 francois.becmeur@chru-strasbourg.fr

Locations
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France
Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: François BECMEUR, MD    33.3.88.12.73.13    francois.becmeur@chru-strasbourg.fr   
Principal Investigator: Francois BECMEUR, MD         
Sub-Investigator: Raphaël MOOG, MD         
Sub-Investigator: Isabelle KAUFFMANN, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: François BECMEUR, MD Hôpitaux Universitaires de Strasbourg
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Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00367159    
Other Study ID Numbers: 3490
TC 197
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: February 25, 2009
Last Verified: February 2009
Keywords provided by University Hospital, Strasbourg, France:
Vesico-ureteral reflux, autologous adipocytes, adipocytes graft
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases