Trial document




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  DRKS00009242

Trial Description

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Title

Near-infrared autofluorescence guided intraoperative identification of parathyroid glands to prevent postoperative hypoparathyreoidism. A randomized controlled pilot trial.

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Trial Acronym

ILPAPH

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Thyroid surgery is one of the most common operations in Germany. Besides laryngeal nerve paralysis hypoparathyreoidism is the most frequent complication. Patients present with complaints of paresthesia or muscle spasms. Usually an inadvertent resection or damage of the afferent vessel causes a hypofunction of the parathyroid glands.
The intraoperative detection of these glands has always been a challenge for surgeons due to their variable location, small size and appearance. As reported by Paras et al. parathyroid tissue shows consistently greater autofluorescence intensity than thyroid or fat tissue when excited with near-infrared light (Paras et al., J Biomed Opt., 2011). Current papers describe a detection rate of nearly 100% (McWade et al., J Clin Endocrinol Metab., 2014).
In this trial we try to demonstrate that using intraoperative near infrared autofluorescence can facilitate the identification of parathyroid glands and avoid severe postoperative complications as hypocalcaemia and hypoparathyreoidism.

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Organizational Data

  •   DRKS00009242
  •   2015/09/03
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  •   yes
  •   Approved
  •   164/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1173-7197 
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Health Condition or Problem studied

  •   E20.9 -  Hypoparathyroidism, unspecified
  •   E04.8 -  Other specified nontoxic goitre
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Interventions/Observational Groups

  •   Identification of parathyroid glands visually and by NIR autofluorescence
  •   Identification of parathyroid glands visually
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Incidence of postoperative hypoparathyreoidism defined by postsurgical parathormon levels <15ng/l

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Secondary Outcome

Symptoms of hypocalcemia, hospital discharge

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/08/17
  •   60
  •   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

Total thyroidectomy for multinodulargoiter. Minimum Age 18 years. No Maximum Age. Both sexes

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Exclusion Criteria

Thyroid malignancies, parathyroid Adenoma, prior thyroid operations

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Addresses

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    • Schwarzwald-Baar KlinikumKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Prof. Dr. med. Dr. h.c.  Norbert  Runkel 
    • Klinikstraße 11
    • 78052  Villingen-Schwenningen
    • Germany
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    • Schwarzwald-Baar Klinikum Villingen-SchwenningenKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr. med.  Henning  Wolf 
    • Klinikstraße 11
    • 78052  Villingen-Schwenningen
    • Germany
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    • Schwarzwald-Baar Klinikum Villingen-SchwenningenKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr. med.  Henning  Wolf 
    • Klinikstraße 11
    • 78052  Villingen-Schwenningen
    • Germany
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Sources of Monetary or Material Support

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    • Karl Storz GmbH & Co KG
    • 78532  Tuttlingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/03
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Trial Publications, Results and other Documents

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