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

NCT02744651 | Terminated

• 1 other identifier: Endodrill III
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  Number of biopsies with the correct histopathological diagnoses

  24 months

Study Arms (2)

EUS-FNA

ACTIVE COMPARATOR

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

EUS-Endodrill biopsy

ACTIVE COMPARATOR

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

Interventions

EUS-FNA DEVICE

Please note the text in section "Arm description"

EUS-FNA

EUS-Endodrill biopsy DEVICE

Please note the text in section "Arm description"

EUS-Endodrill biopsy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy

You may not qualify if:

• Mental illness
• Extreme co-morbidity

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

University Hospital of Lund

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jan Johansson, SrConsultant

  Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Surgeon

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 20, 2016
• Study Start: February 17, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)