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

Vesico-Ureteral Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00367159
• Other study ID #: 3490
• Secondary ID: TC 197
• Status: Recruiting
• Phase: Phase 3
• First received: August 21, 2006
• Last updated: February 24, 2009
• Start date: January 2007
• Est. completion date: February 2021

Study information

• Verified date: February 2009
• Source: University Hospital, Strasbourg, France
• Contact: François BECMEUR, MD
• Phone: 33.3.88.12.73.13
• Email: francois.becmeur[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: February 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Vesico-Ureteral Reflux

Intervention

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

Locations

Country	Name	City	State
France	Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Realization of an urethrocystography		at 3 months and 1 year	Yes
Secondary	Clinical or biological diagnosis of a pyelonephritis during the follow up (10 years)		Day 1; Month 1; Month 3 ; Year 1; Year 5 and Year 10	Yes