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临床试验/NCT03913416
NCT03913416尚未招募不适用

Can Pre-operative Flexible 3D Models of Pulmonary Malformations Facilitate Thoracoscopic Resection

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2020年9月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
178
试验地点
1
主要终点
proportion of intent to treat under thoracoscopy vs thoracotomy procedures

研究概览

简要总结

The National Rare Diseases plans, the ongoing MALFPULM PHRC and thoracoscopic advents in children, are remarkable improvements in understanding and managing lung malformations. The resection of these malformations is now proposed in most cases to avoid infections which are difficult to treat and to diagnose or to avoid exceptional tumors. Procedures are ideally performed around the age of 5-6 months to take advantage of the lung growth that continues during the first two years of life. The surgical strategies depend of the malformation size, the tumor risk and surgeon choice: conservative surgery with removal of part of the lobe may be preferred over complete resection of the concerned lobe.

If possible, thoracoscopic resection is carried out. The open thoracotomy is more painful and leads to complications such as thoracic deformities, larger scars, blood loss. However, in infants the thoracoscopic work space is small, lung exclusion is challenging and the anatomy (normal or malformative) is difficult to understand in space. The rate of thoracoscopy without conversion to thoracotomy ranges from 98% in one American center with a more radical approach , to 48% in a national cohort. Pulmonary exclusion failure, complexity and size of malformations and intra-operative complications are factors of conversion to thoracotomy . These factors can lead surgeons to perform thoracotomy without attempting thoracoscopy.

3D printing is a thriving research field for its educational or therapeutic potential optimization of management, prosthesis, and organ replacement. 3D printing is particularly adapted to pediatrics, which suffers from the rarity of its pathologies and a large spectrum of size and morphology prohibiting the mass production of models. 3D printing models of complex pulmonary pathologies will allowed for a better anesthetic and surgical approach. The modeling of bronchial, vascular and even parenchymatous anatomy permits a better understanding of the anatomical particularities of each patient. This, in turn, avoids the intra-operative conversions to thoracotomy with a direct benefit for the patient.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 1 day to 24 months.
  • Patients with pulmonary malformation eligible for surgery
  • Parents agreement for surgical treatment
  • Parents able to sign an informed consent form
  • Patient benefiting from a social insurance system or a similar system

排除标准

  • Emergency surgeries (less than 15 days between scanner and surgery)
  • Obvious extrapulmonary sequestration on tomographic scanning images
  • Patients with other major malformation additionally to pulmonary malformation
  • Parents unable to understand the purpose of the trial
  • Patient already participating to another clinical trial that might jeopardize the current trial

结局指标

主要结局

proportion of intent to treat under thoracoscopy vs thoracotomy procedures

时间窗: Day 1

Comparisonbetween the 2 groups.

次要结局

  • percentage of analgesic treatments(Day 10)
  • Length of hospital stay(Day 10)
  • resection complexity classification(Day 10)
  • conversion rate from thoracoscopy over thoracoscopy attempted.(Day 1)
  • Proportion of effective pulmonary exclusion of the operated lung.(Day 1)
  • Proportion of variation between preoperative and effective strategy(Day 1)
  • number of complications (duration of postoperative air leak greater than 5 days)(Day 10)
  • number of complications (reoperation)(Day 10)
  • number of complications (pneumothorax).(Day 10)
  • Drainage duration(Day 10)
  • induction time(Day 1)
  • Blood loss(Day 1)
  • number of residual lesions assessed on TDM scanner images(1 year)
  • Evaluation of pain using EVENDOL scale(Hour 72)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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