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

NCT ID: NCT00367159

Last Updated: 2009-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2021-02-28

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.

Conditions

Vesico-Ureteral Reflux

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

endoscopic treatment of vesico-renal reflux

Autologous Adipocytes Graft (lipostructure)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Principal Investigators

François BECMEUR, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Service de Chirurgie Infantile, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François BECMEUR, MD

Role: CONTACT

francois.becmeur@chru-strasbourg.fr

33.3.88.12.73.13

Facility Contacts

François BECMEUR, MD

Role: primary

francois.becmeur@chru-strasbourg.fr

33.3.88.12.73.13

Other Identifiers

TC 197

Identifier Type: -

Identifier Source: secondary_id

3490

Identifier Type: -

Identifier Source: org_study_id