Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument
NCT ID: NCT02161029
Last Updated: 2019-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2014-07-02
2015-03-27
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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New drill biopsy instrument
To take biopsies from gastric submucosal tumors with a new drill biopsy instrument used with flexible endoscopes.
Flexible drill biopsy instrument
Biopsies taken with the new drill biopsy instrument for flexible endoscopy
Conventional biopsy instrument
To take biopsies from gastric submucosal tumors with conventional biopsy forceps used with flexible endoscopes
conventional biopsy instrument
Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments
Interventions
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Flexible drill biopsy instrument
Biopsies taken with the new drill biopsy instrument for flexible endoscopy
conventional biopsy instrument
Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Submucosal hemangioma
ALL
No
Sponsors
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Lund University
OTHER
Lund University Hospital
OTHER
Region Skane
OTHER
Responsible Party
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Bruno Walther
Professor
Principal Investigators
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Bruno S Walther, MD
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Department of Surgery, Lund University
Lund, , Sweden
Countries
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Related Links
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Related Info
Other Identifiers
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2014/97
Identifier Type: -
Identifier Source: org_study_id
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