Impedance Spectroscopy in Esophageal Cancer

NCT04046601 | Completed

• 1 other identifier: Barrett08/2019
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Esophagus

Keywords

impedance, Barrett´s cancer, early detection of cancer

Outcome Measures

Primary Outcomes (1)

• impedance

  value of 17 different frequencies in ohm

  10 min

Secondary Outcomes (1)

• differences in impedance

  10 min

Study Arms (1)

Impedance

EXPERIMENTAL

every resected tissue will measured by an impedance probe

Device: impedance

Interventions

impedance 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.

Impedance

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Known esophageal cancer and planned for endoscopic resection

You may not qualify if:

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

Sponsors & Collaborators

• Sana Klinikum Offenbach: lead

Study Sites (1)

Sana Clinic Offenbach

Offenbach, Hesse, 63609, Germany

Location

Related Publications (1)

• 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.

  PMID: 34559362 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Mate Knabe, MD

  Sana Klinikum Offenbach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 6, 2019
• Study Start: October 9, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 15, 2020
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: 6 month
• Access Criteria: Data access request will be discussed by an internal board . Requestors will be required to sign a Data Access Agreement.

Locations

DE (1)