Esophageal NeoplasmNCT02601079
Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis
A study testing Endodrill Biopsy and Conventional Biopsy forceps in people with Esophageal Neoplasm, run by Region Skane at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Neoplasm
- What is being tested?
- Endodrill Biopsy and Conventional Biopsy forceps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study.
Who cannot join
- Mental illness
- Extreme co-morbidity (ASA >3)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Neoplasm
- Being tested
- Endodrill Biopsy, Conventional Biopsy forceps
- Keywords
- Biopsy, Diagnostics, Genetic analysis
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodrill BiopsyDevice
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.
Conventional Biopsy forcepsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional biopsy | Active comparator | 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. Receives: Device: Conventional Biopsy forceps |
| Endodrill biopsy | Active comparator | 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. Receives: Device: Endodrill Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue.
Measured: 12 months
Secondary outcomes (2)
Number of genetic point mutations in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
Measured: 12 months
Number of fusion genes in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startSep 2016
- Primary completion30 May 2019
- Study completionJun 2019
Why it stopped: Interim analysis showed very low possibility for significant differences between the two instruments.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Jeremiasen, Region Skane
- Investigators
- Jan Johansson, SrConsultant, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601079
- Sponsor's protocol ID
- Endodrill I
- Status last verified
- Mar 2020
- First submitted
- 27 Oct 2015
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis in Tumors of the Distal Esophagus and Cardia
- ClinicalTrials.gov ID
- NCT02601079
- Acronym / sponsor ID
- Endodrill I
- Conditions
- Esophageal Neoplasm
- Keywords
- Biopsy, Diagnostics, Genetic analysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed very low possibility for significant differences between the two instruments.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional biopsy | Active comparator | Device: Conventional Biopsy forceps4 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. |
| Endodrill biopsy | Active comparator | Device: Endodrill Biopsy4 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study.
Key exclusion criteria (2 listed)
- Mental illness
- Extreme co-morbidity (ASA >3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endodrill BiopsyTesting 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. | Device | Endodrill biopsy |
| Conventional Biopsy forcepsUsing 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. | Device | Conventional biopsy |
Primary outcome
Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue.
Time frame: 12 months
2 secondary outcomes
Number of genetic point mutations in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
Time frame: 12 months
Number of fusion genes in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Interim analysis showed very low possibility for significant differences between the two instruments.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Johansson, SrConsultant principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodrill Biopsy and Conventional Biopsy forceps in people with Esophageal Neoplasm, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis showed very low possibility for significant differences between the two instruments.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.