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

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ClinicalTrials.gov Identifier: NCT00511264
Recruitment Status : Completed
First Posted : August 3, 2007
Last Update Posted : May 29, 2008
Sponsor:
Information provided by:
Odense University Hospital

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
Esophageal Cancer Gastric Cancer Pancreatic Cancer Liver Cancer

Study Type : Observational
Estimated 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 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Ultrasound
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven upper GI tract cancer
  • Laparoscopic Ultrasound indicated during pre-treatment evaluation

Exclusion Criteria:

  • Patients unfit for surgery

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): NCT00511264


Locations
Denmark
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

ClinicalTrials.gov Identifier: NCT00511264     History of Changes
Other Study ID Numbers: 2007-10
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by Odense University Hospital:
Laparoscopy
Ultrasound
Cancer
Biopsy

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Liver Diseases