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