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

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ClinicalTrials.gov Identifier: NCT02744651
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Jeremiasen, 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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Neoplasms Device: EUS-FNA Device: EUS-Endodrill biopsy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: 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.
Device: EUS-FNA
Please note the text in section "Arm description"

Active Comparator: 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.
Device: EUS-Endodrill biopsy
Please note the text in section "Arm description"




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744651


Contacts
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Contact: Martin J Jeremiasen, Consultant +46-70-3304950 martin.jeremiasen@med.lu.se
Contact: Jan Johansson, SrConsultant +46-46-171000 jan.johansson@med.lu.se

Locations
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Sweden
University Hospital of Lund Recruiting
Lund, Skane, Sweden, 22185
Contact: Martin j Jeremiasen, MD    +46-70-3304950    martin.jeremiasen@med.lu.se   
Contact: Jan Johansson, MD    +46-46-171432    jan.johansson@med.lu.se   
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Jan Johansson, SrConsultant Region Skåne

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Responsible Party: Martin Jeremiasen, Consultant Surgeon, Region Skane
ClinicalTrials.gov Identifier: NCT02744651     History of Changes
Other Study ID Numbers: Endodrill III
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases