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

Not Applicable

Terminated

• Conditions: Gastrointestinal Neoplasms
• Interventions: Device: EUS-FNA; Device: EUS-Endodrill biopsy

• Registration Number: NCT02744651
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Study Start: 2017-02-17
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-10
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-FNA	EUS-FNA	All patients with a confirmed suspicion of a submucosal tumor in the upper GI tract will be included in this study. A senior endoscopist will perform multiple passes of EUS-FNA until she/he has collected enough material for the pathologist to establish a possible diagnosis.
EUS-Endodrill biopsy	EUS-Endodrill biopsy	All patients who are included in the study will also be examined by a senior endoscopist performing multiple EUS guided passes with the Endodrill biopsy. The harvested tissue from the tumor will be examined by a pathologist in order to establish a diagnosis.

Primary Outcome Measures

Name	Time	Method
Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.	24 months	Number of biopsies with the correct histopathological diagnoses

Trial Locations

Locations (1)

University Hospital of Lund; 🇸🇪 Lund, Skane, Sweden