Impedance Spectroscopy in Esophageal Cancer

Cancer of Esophagus Clinical Trial

Official title:

Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04046601
• Other study ID #: Barrett08/2019
• Status: Completed
• Phase: N/A
• Start date: October 9, 2019
• Est. completion date: February 15, 2020

Study information

• Verified date: January 2023
• Source: Sana Klinikum Offenbach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 neoplasia 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.

Description:

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 neoplasia 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 15, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

Known esophageal cancer and planned for endoscopic resection

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

Related Conditions & MeSH terms

• Cancer of Esophagus
• Esophageal Neoplasms

Intervention

Device:
• impedance
After endoscopic resection of early esophageal cancer, the tissue will be measured by an impedance probe between 10Hz-1000000Hz, 20mV. 8 gold electrodes have been integrated to the probe. The impedance will be measured in different ways between the elctrodes. There will be 10 measurements in total for each specimen.

Locations

Country	Name	City	State
Germany	Sana Clinic Offenbach	Offenbach	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Sana Klinikum Offenbach

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	impedance	value of 17 different frequencies in ohm	10 min
Secondary	differences in impedance	Differences in electrical impedance properties between different stages of early esophageal cancer.	10 min