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临床试验/NCT04384939
NCT04384939已完成不适用

Feasibility, Safety and Medico-economic Study of Magnetic-end Double-J Ureteral Stent Use in Children

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2021年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
主要终点
Successful removal of the Double-J ureteral stent with magnet

研究概览

简要总结

Double-J ureteral stent (DJUS) is one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.

Classically, DJUS are introduced and removed in the operation room, under general anesthesia, using a cystoscope.

The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop.

To remove the magnetic stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip is inserted into the urethra in the outpatient clinic.

The purpose of this study is to demonstrate the feasibility and safety of magnetic-end Double-J ureteral stent use in children and to perform a medico-economic study.

详细描述

First reported in 1967, ureteral stenting evolved fast until the introduction of the double-J ureteral stent (DJUS) in 1978. It has since become one of the most common devices used in urology. Ureteral stenting has a wide spectrum of indications that can be summarized in two words: obstruction and leakage. Common indications in pediatric urology are pyeloplasty, ureteral reimplantation, kidney transplantation and stone disease.

Many modifications have been introduced to Finney's double-J to reduce stent-related complications and disadvantages, one of which is its removal technique. Classically, DJUS are introduced and removed in the operation room (OR), under general anesthesia (GA), using a cystoscope. Efforts have been made to avoid the second procedure under GA. Preventing the patient from undergoing a second OR experience is not the only issue. For institutions, DJUS removal is time consuming and costly in terms of resources, OR occupancy, and staff. In children, the potential neurotoxicity of repeated exposures to GA, is also a major concern.

Alternatives to surgical removal of DJUS vary from basic solutions such as transurethral string, hook, or other tools, to more complex innovations such as the single use flexible cystoscope, and biodegradable stents. Moreover, some pediatric teams used the externalized pyeloureteral stent as an alternative to DJUS. Using magnet for ureteral stent retrieval was introduced in the early 80s. Difficulties related to its insertion, as well as its low retrieval success rate, minimized its acceptance. It wasn't until 2002 when Taylor and McDougall revisited the concept of magnetic retrieval of the ureteral stent. Since then, few teams have published their experience with magnetic-end DJUS.

The magnetic-end Double-J ureteral stent is a 4.8 French DJUS with a small magnet fixed with a string at the distal loop. Explanation of the retrieval method and its potential complications are given to the parents, and informed consent obtained prior to surgery. All of the stents are inserted under GA in the exact same manner as regular DJUS: antegrade, retrograde (cystoscopy insertion) or open surgery. The stent's length varies between 12 and 24 cm depending on the age and weight of the child. An abdominal plain X-Ray is routinely done after pyeloplasty to check the position of the DJUS distal loop (MEDJUS or not) in the bladder before waking up the child. A successful stent insertion is defined as having a good position of the distal end and its magnet in the bladder

To remove the magnetic-end Double-J ureteral stent, a 9 French customized catheter-like retrieval device with a magnetic Tiemann tip, lubricated with 2% lidocaine jelly, is inserted into the urethra by the surgeon with the patient breathing inhaled premixed nitrous oxide and oxygen for procedural sedation in the outpatient clinic. Both indwelling magnets connect and the catheter can be removed together with the MEDJUS. Success of magnetic retrieval are regarded as MEDJUS retrieval in outpatient clinic with no need of general anesthesia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child aged between 0 and 17 years and 10 months at the surgery
  • Child operated at the Necker hospital for an uropathy or kidney graft need the insertion of JJ ureteral stent
  • Parents or legal guardians signed the Informed consent form
  • Social insurance affiliation

排除标准

  • All clinical situation need an MRI
  • Contraindication with the experimental medical device (severe infections, obstruction, …)
  • For the medico-economic study, a comparative group will be constituted with patients treated with classic ureteral stent in the Necker hospital in the previous years.
  • This group will be matched with age (<5 years, 5-12 years and >13years), sex and surgery indication (kidney graft or other).

结局指标

主要结局

Successful removal of the Double-J ureteral stent with magnet

时间窗: During the stent removal consultation, usually between 8 and 30 days after the surgery

A successful removal is a removal of the Double-J (JJ) ureteral stent with the magnet removal system, without general anaesthesia - The measure is a binary criterion: success/ failure, evaluated by the surgeon

次要结局

  • Successful insertion of the Double-J ureteral stent with magnet(1 day)
  • Duration of hospitalization(At the end of the initial hospitalisation, at maximum 60 days)
  • Costs of hospitalization after surgery(Until the stent removal consultation, usually between 8 and 30 days after the surgery)
  • Pain score(At the end of the stent removal)
  • Anxiety score(At the end of the stent removal)
  • Satisfaction survey of parents(at the end of the stent removal and day 7 after)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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