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Flexible Endoscopy Biopsies for Submucous Tumors With a New Drill Instrument

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ClinicalTrials.gov Identifier: NCT02161029
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Lund University
Lund University Hospital
Information provided by (Responsible Party):
Bruno Walther, Region Skane

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Gastric Tumor Device: Flexible drill biopsy instrument Device: conventional biopsy instrument Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Flexible Endoscopy Biopsies With the New Drill Biopsy Instrument for Submucous Tumors
Actual Study Start Date : July 2, 2014
Actual Primary Completion Date : March 27, 2015
Actual Study Completion Date : March 27, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: New drill biopsy instrument
To take biopsies from gastric submucosal tumors with a new drill biopsy instrument used with flexible endoscopes.
Device: Flexible drill biopsy instrument
Biopsies taken with the new drill biopsy instrument for flexible endoscopy
Other Name: Endodrill (=Internal code name)

Active Comparator: Conventional biopsy instrument
To take biopsies from gastric submucosal tumors with conventional biopsy forceps used with flexible endoscopes
Device: conventional biopsy instrument
Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Submucous gastrointestinal tumours

Exclusion Criteria:

  • No gastrointestinal submucous tumor
  • Submucosal hemangioma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161029


Locations
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Sweden
Department of Surgery, Lund University
Lund, Sweden, SE-22185
Sponsors and Collaborators
Region Skane
Lund University
Lund University Hospital
Investigators
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Principal Investigator: Bruno S Walther, MD Professor
Additional Information:
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Responsible Party: Bruno Walther, Professor, Region Skane
ClinicalTrials.gov Identifier: NCT02161029    
Other Study ID Numbers: 2014/97
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Bruno Walther, Region Skane:
Gastric tumor
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases