Clinical trial NCT04046601: Impedance Spectroscopy in Esophageal Cancer
Official title: Diagnosis of Early Barrett's Neoplasia and Esophageal Squamous Cell Neoplasia by Electrical Impedance Spectroscopy in Human Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Esophagus
Keywords: impedance, Barrett´s cancer, early detection of cancer
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: impedance
timeFrame: 10 min
Secondary outcomes:
measure: differences in impedance
timeFrame: 10 min
Other outcomes:
Locations:
city: Offenbach
country: Germany
facility: Sana Clinic Offenbach
state: Hessen
Study officials:
affiliation: Sana Klinikum Offenbach
name: Mate Knabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.