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

Primary Purpose

Gastrointestinal Neoplasms

Status

Terminated

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

EUS-FNA

EUS-Endodrill biopsy

About this trial

This is an interventional diagnostic trial for Gastrointestinal Neoplasms

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Lund

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

EUS-FNA

EUS-Endodrill biopsy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Number of biopsies with the correct histopathological diagnoses

Secondary Outcome Measures

Full Information

NCT ID

NCT02744651

First Posted

April 5, 2016

Last Updated

January 10, 2022

Sponsor

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT02744651

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Practical circumstances making it not possible to finish the study.

Study Start Date

February 17, 2017 (Actual)

Primary Completion Date

December 31, 2021 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Neoplasms

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EUS-FNA

Arm Type

Active Comparator

Arm Description

Arm Title

EUS-Endodrill biopsy

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

EUS-FNA

Intervention Description

Please note the text in section "Arm description"

Intervention Type

Device

Intervention Name(s)

EUS-Endodrill biopsy

Intervention Description

Please note the text in section "Arm description"

Primary Outcome Measure Information:

Title

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

Description

Number of biopsies with the correct histopathological diagnoses

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Johansson, SrConsultant

Organizational Affiliation

Region Skåne

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Lund

City

Lund

State/Province

Skane

ZIP/Postal Code

22185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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