Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis

Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis in Tumors of the Distal Esophagus and Cardia

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purposes of this study are as follows:

• Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis based on collected biopsies of tumors in the upper GI tract.
• Based on the quality of the collected tissue samples we want to evaluate which instrument generates the most useful material for genetic studies of the tumor.

Study Overview

• Status: Terminated
• Conditions: Esophageal Neoplasm
• Intervention / Treatment: Device: Conventional Biopsy forceps; Device: Endodrill Biopsy

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´s ability to obtain representative tissue samples from tumors in the distal esophagus and cardia with a conventional biopsy forceps. In addition the investigators want to compare the tissue samples in terms of weight, quality, artefacts and whether either instrument is more suited for collecting tissue for genetic analysis. Such analysis will be conducted with Next-Generation Sequensing (NGS) of the whole exome, Whole Exome Sequensing (WES). In the event of positive results from these analysis the investigators will also conduct RNA-sequencing of the tumor tissue in order to start pre-operative mapping of genetic abnormalities.

20 patients will be enrolled for this study. For each patient the investigators will collect 10 biopsies, 5 biopsies each with conventional biopsy and the Endodrill instrument respectively. The order will be randomized for each patient. For each specific biopsy the investigator will choose a particular site on the suspected tumor tissue without knowing which instrument that will be used for the biopsy. This procedure will be repeated for all 10 biopsies.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 22185
      • University Hospital of Lund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study.

Exclusion Criteria:

• Mental illness
• Extreme co-morbidity (ASA >3)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional biopsy; 4 out of 8 biopsies taken with a conventional biopsy forceps from the tumor tissue in the distal esophagus and cardia. The biopsies will be taken in random order "blinded" for the person performing the examination. 1 additional biopsy will be taken from the tumor tissue in order to be evaluated for appropriateness of further genetic analysis. Both type of biopsies will be taken from the same patient. In total 10 biopsies per patient.	Device: Conventional Biopsy forceps; Using a conventional biopsy forceps for taking tissue biopsies in the GI tract. The investigators will use conventional biopsy forceps in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the conventional biopsy forceps can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.
Active Comparator: Endodrill biopsy; 4 out of 8 biopsies taken with the Endodrill instrument from the tumor tissue in the distal esophagus and cardia. The biopsies will be taken in random order "blinded" for the person performing the examination. 1 additional biopsy will be taken from the tumor tissue in order to be evaluated for appropriateness of further genetic analysis. Both type of biopsies will be taken from the same patient. In total 10 biopsies per patient.	Device: Endodrill Biopsy; Testing a new device for taking tissue biopsies in the GI tract. The investigators will use the Endodrill instrument in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the Endodrill instrument can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of genetic point mutations in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.	12 months
Number of fusion genes in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.	12 months

Collaborators and Investigators

• Sponsor: Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: November 7, 2015
• First Posted (Estimate): November 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Biopsy; Diagnostics; Genetic analysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: Endodrill I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No