Trial document




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  DRKS00003358

Trial Description

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Title

Diagnosis of early Barrett’s neoplasia and esophageal squamous cell neoplasia by electrical bio-impedance spectroscopy in human tissue

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Trial Acronym

-

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Early stages of esophageal cancers can be treated by endoscopic resection whereas advanced neoplasias might lead to an Operation of the esophagus. Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory tissue and cancer can be sensed by electrical bioimpedance technique.
The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.

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Brief Summary in Scientific Language

Detection of early esophageal cancer in surrounding normal tissue can be challenging even for experienced examiners. The early detection is essential to determine the following treatment. Early stages of esophageal cancers can be treated by endoscopic resection (ER) whereas advanced neoplasias might lead to esophagectomy. Diagnosis is made usually by biopsies of suspicious lesions or untargeted quadrant biopsies. The electrical properties in inflammatory tissue and dysplasia can be sensed by electrical bioimpedance technique. The aim of this study is to compare the impedance probe with the histological result and to investigate the feasibility of the new technique in detection of esophageal cancer.

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Organizational Data

  •   DRKS00003358
  •   2011/11/28
  •   [---]*
  •   yes
  •   Approved
  •   FF 74/2011, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C15.9 -  Malignant neoplasm: Oesophagus, unspecified
  •   K22.7 -  Barrett's oesophagus
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Interventions/Observational Groups

  •   Observation group: patient who are planned for endoscopic resection because of known esophageal cancer. Immediately after retrieval the resected specimens were investigated for their electrical impedance properties. The results of the impedance measurement are compared to the histological results.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

The primary endpoint of the study is to demonstrate that different types of esophageal tissue can be distinguished by their electrical impedance properties. For this purpose the tissue is measured by an electrode directly after resection. The measurement is done over 17 different frequencies in [ohm]. The result is shown as a graph. Subsequently the histological results are compared to the graphs. Finally significant differences are evaluated.

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Secondary Outcome

Differences in electrical impedance properties between different stages of early esophageal cancer. The measurments are done in the same way as mentioned at the point of primary outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/12/01
  •   15
  •   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

Known esophageal cancer and planned for endoscopic resection

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Exclusion Criteria

1. Missing consent / agreement
2. Patient in bad condition for endoscopy or endoscopic resection
3. Patients with coagulopathy or anticoagulative medication which is a contraindication for endoscopy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Dr. Horst-Schmidt-Klinik Wiesbaden II. Medizinische Klinik
    • Mr.  PD Dr. med  Oliver   Pech 
    • Ludwig-Erhard-Str. 100
    • 65199   Wiesbaden
    • Germany
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    • Dr. Horst-Schmidt-Klinik Wiesbaden II. Medizinische Klinik
    • Mr.  PD Dr. med  Oliver   Pech 
    • Ludwig-Erhard-Str. 100
    • 65199   Wiesbaden
    • Germany
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    • Dr. Horst-Schmidt-Klinik Wiesbaden II. Medizinische Klinik
    • Mr.  PD Dr. med  Oliver   Pech 
    • Ludwig-Erhard-Str. 100
    • 65199   Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • Dr. Horst-Schmidt-Klinik Wiesbaden II. Medizinische Klinik
    • Mr.  PD Dr. med  Oliver   Pech 
    • Ludwig-Erhard-Str. 100
    • 65199   Wiesbaden
    • Germany
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    • Department Biomedical Microsystems Fraunhofer-Institute for Biomedical Engineering
    • Mr.  Dr  Thomas  Vellten 
    • Ensheimer Strasse 48
    • 66386  St. Ingebert
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/02/08
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Trial Publications, Results and other Documents

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