Trial document




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  DRKS00012802

Trial Description

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Title

Prediction of post-operative pulmonary function in patients planned for anatomic lung resection: comparison between scintigraphic planar perfusion imaging, calculation of resected functional segments and CT guided tomographic perfusion imaging assessments

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a retro- and prospective, open, monocentric study. The aim of the study is to perform a restrospective and prospective analysis on preoperative evaluation of patients suitable for surgical resection with planar perfusion scintigraphy and CT guided tomographic perfusion imaging by predicting the postoperative lung function.

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Brief Summary in Scientific Language

The preoperative evaluation and prediction of the post-operative lung function after lobar and sublobar resection in lung carcinoma patients is essential to prevent unexpected respiratory failure in patients with poor respiratory reserve. These patients have frequent associated impaired pulmonary function, mainly secondary to chronic airway obstruction. Impaired patients, bearing poor respiratory reserve and referred for curative surgery are exposed to severe postoperative complications as well as a poor quality of life outcome. Lung function tests, anatomic evaluations as well as pre- operative lung imaging procedures are being used to predict post-operative function in lung cancer patients undergoing lobectomy.
The American College of Chest Physicians as well as the British Thoracic Society still recommend using quantitative relative perfusion scintigraphy in patients identified with borderline spirometric lung function — both in pre-operative lung assessment and evaluation of expected residual function after surgery. The pre-operative planar scintigraphic quantification method is well established in predicting post-operative residual lung function. It is easily implemented but is also known to have a greater margin of uncertainty to assess lobar function. Combining the functional data provided by SPECT perfusion imaging with the anatomical information provided by CT could improve the pre-operative quantification of lung function before resection.
From the collaborative work and scientific exchanges, we aim to develop a truly anatomical based method for relative pulmonary lobar perfusion fraction quantification using SPECT-CT. We want to compare SPECT imaging results with those from planar imaging assessments in lung cancer patients. These imaging functional perfusion results are also to be compared to post-operative spirometric evaluations for each patient to assess their residual function evaluation predictive value.
The aim of this study is to improve the preoperative assessment of candidates for anatomical lunge resections.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012802
  •   2019/05/27
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  •   yes
  •   Approved
  •   211/18, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   The following data will be collected and analysed
    Age, sex, date of primary surgery, preoperative lung function, surgical technique, surgical access, extent of resection, duration of hospitalization, postoperative complications, TNM staging, neoadjuvant/adjuvant systemic treatments (chemotherapy, radiotherapy), postoperative complications, 3-month postoperative lung function
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is the 3-month lung function evaluation of all patients, postoperative morbidity and mortality.

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Secondary Outcome

The secondary endpoint is to demonstrate additionally if other criteria having influence on the postoperative lung function.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/06/03
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Patients with a DLCO of 60% or less
2. Patients with a FEV1 of 1,5 L or less
3. Treated with curative intent at the Dept. for Thoracic Surgery from 2017-2019
4.≥18 years old
5.Written informed consent

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Exclusion Criteria

none

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Addresses

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    • UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie, Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Thoraxchirurgie
    • Mr.  Dr.  Laurin  Titze 
    • Hugstetter 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURG, Klinik für Thoraxchirurgie
    • Ms.  Christine  von Nida 
    • Hugstetterstr. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie, Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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