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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02744651
Enrollment
4
Registered
2016-04-20
Start date
2017-02-17
Completion date
2021-12-31
Last updated
2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasms

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.

Interventions

DEVICEEUS-FNA

Please note the text in section Arm description

DEVICEEUS-Endodrill biopsy

Please note the text in section Arm description

Sponsors

Region Skane
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.24 monthsNumber of biopsies with the correct histopathological diagnoses

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026