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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Withdrawn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
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stomach Neoplasms focused on measuring Diagnostics, Biopsy, Diffuse gastric cancer

Eligibility Criteria

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

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

    First Posted
    October 27, 2015
    Last Updated
    November 22, 2018
    Sponsor
    Region Skane
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    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    Withdrawn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

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