Gastric TumorNCT02161029
Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument
A study testing Flexible drill biopsy instrument and conventional biopsy instrument in people with Gastric Tumor, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether the newly constructed CE (Conformité Européenne) marked drill biopsy instrument for flexible endoscopes can make possible representative biopsies of the increasing numbers of submucosal tumours in the gastrointestinal tract. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Tumor
- What is being tested?
- Flexible drill biopsy instrument and conventional biopsy instrument
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jul 2014to 27 Mar 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Submucous gastrointestinal tumours
Who cannot join
- No gastrointestinal submucous tumor
- Submucosal hemangioma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flexible Endoscopy Biopsies With the New Drill Biopsy Instrument for Submucous Tumors
The purpose of this study is to determine whether the newly constructed CE (Conformité Européenne) marked drill biopsy instrument for flexible endoscopes can make possible representative biopsies of the increasing numbers of submucosal tumours in the gastrointestinal tract. The amount of submucous tissue ( micrograms and in % of all the biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy investigations is measured in the study and compared to the amount of submucous tissue harvested with the existing biopsy forceps.
Read the detailed description
Background: With the existing biopsy instruments for flexible endoscopy it's only possible to achieve superficial biopsies comprising the mucosa and very seldom some small fragments of the submucosa. It is, however, increasingly important to get biopsies from the submucous tissues because the tumors that are on the increase more than any other in the stomach is the GIST (GastroIntestinal Stroma Tumours) that grows in the submucosa. Cytology is not enough for a reliable diagnosis and to often not representative. Furthermore there is a well-known risk for tract seeding when sampling through the abdominal wall with a fine needle instrument.
The investigators have invented a new biopsy instrument for flexible endoscopy that is a drill within a cylinder that can be used for biopsies of the submucous tissues, for instance GIST-tumours, see www.BIBBInstruments.com.
Hypothesis: Will it be possible to achieve representative submucous tissue from the gastrointestinal tract with the newly constructed drill biopsy instrument for flexible endoscopy. The investigators hypothesize that the amount of tissue harvested with the new drill biopsy instrument will give significantly more amount of tissue to evaluate for the pathologist than the existing biopsy forceps.
Method: Ten patients with tumours in the submucosa of the stomach are examined with a gastroscope. The investigator decides where the first biopsy should be taken and randomly the investigator blindly get the new drill instrument or the conventional biopsy forceps and take the biopsy on the decided localization. The next site of the tumour is decided and again blindly the investigator get one of the two biopsy instruments according to a previously decided scheme. Six biopsies (three with each of the two biopsy tools) in every patient are harvested in ten patients. With altogether 30 specimen for each biopsy instrument and a difference of 1/3 which is a low calculated difference 10 patients as above will give a 80 % Power (Chi-2 = 5.40, p = 0.02*). The amount of submucous tissue harvested with the two biopsy instruments are measured in microgram and as percentage of all the biopsy and compared. The quality of the specimens are also calculated.
- Conditions
- Gastric Tumor
- Being tested
- Flexible drill biopsy instrument, conventional biopsy instrument
- Keywords
- Gastric tumor
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible drill biopsy instrumentDevice
Also called Endodrill (=Internal code name)
Biopsies taken with the new drill biopsy instrument for flexible endoscopy
conventional biopsy instrumentDevice
Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments
| Study group | Role | What they receive |
|---|---|---|
| New drill biopsy instrument | Active comparator | To take biopsies from gastric submucosal tumors with a new drill biopsy instrument used with flexible endoscopes. Receives: Device: Flexible drill biopsy instrument |
| Conventional biopsy instrument | Active comparator | To take biopsies from gastric submucosal tumors with conventional biopsy forceps used with flexible endoscopes Receives: Device: conventional biopsy instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of submucous tissue in gastrointestinal submucosal tumors harvested with a new drill biopsy instrument used with flexible endoscopes.
Amount of submucous tissue adequate for histological examination harvested with the new drill biopsy instrument for flexible endoscopy and compared to the amount harvested with the existing biopsy forceps in a randomized setting.
Measured: Within 30 days for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study start2 Jul 2014
- Primary completion27 Mar 2015
- Study completion27 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric TumorStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Lund University Hospital
- Responsible party
- Principal investigator, Bruno Walther, Region Skane
- Investigators
- Bruno S Walther, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161029
- Sponsor's protocol ID
- 2014/97
- Status last verified
- Jan 2019
- First submitted
- 25 Mar 2014
- Last updated
- 1 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Endoscopy Biopsies With the New Drill Biopsy Instrument for Submucous Tumors
- ClinicalTrials.gov ID
- NCT02161029
- Acronym / sponsor ID
- 2014/97
- Conditions
- Gastric Tumor
- Keywords
- Gastric tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Lund University Hospital
- Study start
- 2 Jul 2014 (actual)
- Primary completion
- 27 Mar 2015 (actual)
- Study completion
- 27 Mar 2015 (actual)
- First posted
- 11 Jun 2014 (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.
The purpose of this study is to determine whether the newly constructed CE (Conformité Européenne) marked drill biopsy instrument for flexible endoscopes can make possible representative biopsies of the increasing numbers of submucosal tumours in the gastrointestinal tract. The amount of submucous tissue ( micrograms and in % of all the biopsy) harvested with the new drill biopsy instrument used in flexible endoscopy investigations is measured in the study and compared to the amount of submucous tissue harvested with the existing biopsy forceps.
Detailed description
Background: With the existing biopsy instruments for flexible endoscopy it's only possible to achieve superficial biopsies comprising the mucosa and very seldom some small fragments of the submucosa. It is, however, increasingly important to get biopsies from the submucous tissues because the tumors that are on the increase more than any other in the stomach is the GIST (GastroIntestinal Stroma Tumours) that grows in the submucosa. Cytology is not enough for a reliable diagnosis and to often not representative. Furthermore there is a well-known risk for tract seeding when sampling through the abdominal wall with a fine needle instrument.
The investigators have invented a new biopsy instrument for flexible endoscopy that is a drill within a cylinder that can be used for biopsies of the submucous tissues, for instance GIST-tumours, see www.BIBBInstruments.com.
Hypothesis: Will it be possible to achieve representative submucous tissue from the gastrointestinal tract with the newly constructed drill biopsy instrument for flexible endoscopy. The investigators hypothesize that the amount of tissue harvested with the new drill biopsy instrument will give significantly more amount of tissue to evaluate for the pathologist than the existing biopsy forceps.
Method: Ten patients with tumours in the submucosa of the stomach are examined with a gastroscope. The investigator decides where the first biopsy should be taken and randomly the investigator blindly get the new drill instrument or the conventional biopsy forceps and take the biopsy on the decided localization. The next site of the tumour is decided and again blindly the investigator get one of the two biopsy instruments according to a previously decided scheme. Six biopsies (three with each of the two biopsy tools) in every patient are harvested in ten patients. With altogether 30 specimen for each biopsy instrument and a difference of 1/3 which is a low calculated difference 10 patients as above will give a 80 % Power (Chi-2 = 5.40, p = 0.02*). The amount of submucous tissue harvested with the two biopsy instruments are measured in microgram and as percentage of all the biopsy and compared. The quality of the specimens are also calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New drill biopsy instrument | Active comparator | Device: Flexible drill biopsy instrumentTo take biopsies from gastric submucosal tumors with a new drill biopsy instrument used with flexible endoscopes. |
| Conventional biopsy instrument | Active comparator | Device: conventional biopsy instrumentTo take biopsies from gastric submucosal tumors with conventional biopsy forceps used with flexible endoscopes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Submucous gastrointestinal tumours
Key exclusion criteria (2 listed)
- No gastrointestinal submucous tumor
- Submucosal hemangioma
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 |
|---|---|---|
| Flexible drill biopsy instrumentAlso: Endodrill (=Internal code name)Biopsies taken with the new drill biopsy instrument for flexible endoscopy | Device | New drill biopsy instrument |
| conventional biopsy instrumentBiopsies taken with conventional biopsy forceps for flexible endoscopic instruments | Device | Conventional biopsy instrument |
Primary outcome
Amount of submucous tissue in gastrointestinal submucosal tumors harvested with a new drill biopsy instrument used with flexible endoscopes.
Time frame: Within 30 days for each patient
Amount of submucous tissue adequate for histological examination harvested with the new drill biopsy instrument for flexible endoscopy and compared to the amount harvested with the existing biopsy forceps in a randomized setting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Related InfoLink provided by the sponsor.
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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.
Bruno S Walther, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible drill biopsy instrument and conventional biopsy instrument in people with Gastric Tumor, 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: finished, as of the sponsor's last update on 1 Feb 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of submucous tissue in gastrointestinal submucosal tumors harvested with a new drill biopsy instrument used with flexible endoscopes. (time frame: Within 30 days for each patient). 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 1 Feb 2019.