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Laparoscopic Ultrasound Guided Tissue Sampling in Patients With Cancer of the Upper Gastrointestinal Tract

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00511264
Collaborator
(none)
250
Enrollment
1
Location
12
Duration (Months)
20.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Laparoscopic Ultrasound (LUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When a suspect lesion is visualized during LUS a biopsy should be provided in order to differentiate between benign and malignant lesions. A new system for LUS guided biopsy has been developed, but how often these biopsies are clinically relevant (i.e. changing patient management)and how reliable are these biopsies are unknown.

The study hypothesis is that LUS guided biopsies are accurate and clinically relevant in the pre-treatment evaluation of patients with upper gastrointestinal tract cancer.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Time Perspective:
    Prospective
    Official Title:
    Prospective Evaluation of the Impact of Laparoscopic Ultrasound (LUS) Guided Fine-Needle Aspiration or Tru-Cut Biopsy in Patients With Upper GI Tract Cancer
    Study Start Date :
    May 1, 2007
    Actual Primary Completion Date :
    May 1, 2008
    Actual Study Completion Date :
    May 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Biopsy proven upper GI tract cancer

      • Laparoscopic Ultrasound indicated during pre-treatment evaluation

      Exclusion Criteria:
      • Patients unfit for surgery

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Surgery, Odense University Hospital Odense Denmark 5000

      Sponsors and Collaborators

      • Odense University Hospital

      Investigators

      • Principal Investigator: Michael B Mortensen, MD, Ph.D., Department of Surgery, Odense University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00511264
      Other Study ID Numbers:
      • 2007-10
      First Posted:
      Aug 3, 2007
      Last Update Posted:
      May 29, 2008
      Last Verified:
      May 1, 2008
      Keywords provided by , ,
      Laparoscopy
      Ultrasound
      Cancer
      Biopsy

      Study Results

      No Results Posted as of May 29, 2008