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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511264
First Posted: August 3, 2007
Last Update Posted: May 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Odense University Hospital
  Purpose

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
Esophageal Cancer Gastric Cancer Pancreatic Cancer Liver Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 250
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

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
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00511264     History of Changes
Other Study ID Numbers: 2007-10
First Submitted: August 1, 2007
First Posted: August 3, 2007
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