Impedance Spectroscopy in Esophageal Cancer

NCT ID: NCT04046601

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-09

Study Completion Date

2020-02-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer of Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

no masking

Study Groups

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Impedance

every resected tissue will measured by an impedance probe

Group Type EXPERIMENTAL

impedance

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sana Klinikum Offenbach

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mate Knabe, MD

Role: PRINCIPAL_INVESTIGATOR

Sana Klinikum Offenbach

Locations

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Sana Clinic Offenbach

Offenbach, Hesse, Germany

Site Status

Countries

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Germany

References

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Blosser S, May A, Welsch L, Ast M, Braun S, Velten T, Biehl M, Tschammer J, Roeb E, Knabe M. Virtual Biopsy by Electrical Impedance Spectroscopy in Barrett's Carcinoma. J Gastrointest Cancer. 2022 Dec;53(4):948-957. doi: 10.1007/s12029-021-00703-0. Epub 2021 Sep 24.

Reference Type DERIVED
PMID: 34559362 (View on PubMed)

Other Identifiers

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Barrett08/2019

Identifier Type: -

Identifier Source: org_study_id

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