Impedance Spectroscopy in Esophageal Cancer

Sponsor

Sana Klinikum Offenbach (Other)

Overall Status

Unknown status

CT.gov ID

NCT04046601

Collaborator

(none)

Enrollment

Location

Arm

13.8

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Esophagus	Device: impedance	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

no masking

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 9, 2019

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Impedance every resected tissue will measured by an impedance probe	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.

Arm

Intervention/Treatment

Experimental: Impedance

every resected tissue will measured by an impedance probe

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.

Outcome Measures

Primary Outcome Measures

impedance [10 min]
value of 17 different frequencies in ohm

Secondary Outcome Measures

differences in impedance [10 min]
Differences in electrical impedance properties between different stages of early esophageal cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Known esophageal cancer and planned for endoscopic resection

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sana Clinic Offenbach	Offenbach	Hessen	Germany	63609

Sponsors and Collaborators

Sana Klinikum Offenbach

Investigators

Principal Investigator: Mate Knabe, MD, Sana Klinikum Offenbach

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sana Klinikum Offenbach

ClinicalTrials.gov Identifier:

NCT04046601

Other Study ID Numbers:

Barrett08/2019

First Posted:

Aug 6, 2019

Last Update Posted:

Dec 9, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sana Klinikum Offenbach

impedance, Barrett´s cancer, early detection of cancer

Additional relevant MeSH terms:

Esophageal Neoplasms

Study Results

No Results Posted as of Dec 9, 2019