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Clinical Trials/NCT02744651
NCT02744651
Terminated
Not Applicable

EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract

Region Skane1 site in 1 country4 target enrollmentFebruary 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Neoplasms
Sponsor
Region Skane
Enrollment
4
Locations
1
Primary Endpoint
Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:

  • Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.

Detailed Description

Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps. In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.

Registry
clinicaltrials.gov
Start Date
February 17, 2017
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martin Jeremiasen

Consultant Surgeon

Region Skane

Eligibility Criteria

Inclusion Criteria

  • All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy

Exclusion Criteria

  • Mental illness
  • Extreme co-morbidity

Outcomes

Primary Outcomes

Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.

Time Frame: 24 months

Number of biopsies with the correct histopathological diagnoses

Study Sites (1)

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