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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00367159
Enrollment
14
Registered
2006-08-22
Start date
2007-01-31
Completion date
2021-02-28
Last updated
2009-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vesico-Ureteral Reflux

Keywords

Vesico-ureteral reflux, autologous adipocytes, adipocytes graft

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.

Interventions

PROCEDUREendoscopic treatment of vesico-renal reflux

Autologous Adipocytes Graft (lipostructure)

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Realization of an urethrocystographyat 3 months and 1 year

Secondary

MeasureTime frame
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

Countries

France

Contacts

Primary ContactFrançois BECMEUR, MD
francois.becmeur@chru-strasbourg.fr33.3.88.12.73.13

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026