Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Boston Scientific Large Capacity with needle Biopsy
Endodrill 1A (BIBBInstruments, Lund, Sweden)
Sponsored by
About this trial
This is an interventional diagnostic trial for Stomach Neoplasms focused on measuring Diagnostics, Biopsy, Diffuse gastric cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with suspected or with an established diagnosis of diffuse gastric cancer who are capable of stating a formal consent to participate in the study.
Exclusion Criteria:
- Mental illness
- Extreme co-morbidity (ASA>3)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional Biopsy
Endodrill Biopsy
Arm Description
4 out of 8 biopsies taken with a Boston Scientific Large capacity with needle biopsy forceps from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.
4 out of 8 biopsies taken with the Endodrill 1A instrument from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.
Outcomes
Primary Outcome Measures
Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer
Secondary Outcome Measures
Amount of (mm2 and %) submucosal tissue within the biopsies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02594943
Brief Title
Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Official Title
Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Too narrow inclusion criteria. Impossible to recruit patients.
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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 the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis of diffuse gastric cancer based on collected biopsies from tumor tissue.
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 a group of patients diagnosed with or suspected diffuse gastric cancer. 20 patients will be enrolled for this study. For each patient the investigators will collect 8 biopsies, 4 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 8 biopsies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Diagnostics, Biopsy, Diffuse gastric cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Biopsy
Arm Type
Active Comparator
Arm Description
4 out of 8 biopsies taken with a Boston Scientific Large capacity with needle biopsy forceps from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.
Arm Title
Endodrill Biopsy
Arm Type
Active Comparator
Arm Description
4 out of 8 biopsies taken with the Endodrill 1A instrument from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.
Intervention Type
Device
Intervention Name(s)
Boston Scientific Large Capacity with needle Biopsy
Intervention Description
The investigators will use a conventional biopsy forceps for taking tissue biopsies in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the conventional biopsy forceps from the tumor tissue.
Intervention Type
Device
Intervention Name(s)
Endodrill 1A (BIBBInstruments, Lund, Sweden)
Intervention Description
The investigators will use the Endodrill, a new device for endoscopic tissue sampling in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the Endodrill instrument from the tumor tissue.
Primary Outcome Measure Information:
Title
Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Amount of (mm2 and %) submucosal tissue within the biopsies.
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
No
Eligibility Criteria
Inclusion Criteria:
Patients with suspected or with an established diagnosis of diffuse gastric cancer who are capable of stating a formal consent to participate in the study.
Exclusion Criteria:
Mental illness
Extreme co-morbidity (ASA>3)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Johansson, SrConsultant
Organizational Affiliation
Region Skåne
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
We'll reach out to this number within 24 hrs