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

This study has been completed.

Sponsored by: Odense University Hospital
Information provided by: Odense University Hospital
ClinicalTrials.gov Identifier: NCT00511264
  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

MedlinePlus related topics:   Cancer    Esophageal Cancer    Esophagus Disorders    Liver Cancer    Pancreatic Cancer    Stomach Cancer    Ultrasound   

U.S. FDA Resources

Study Type:   Observational
Study Design:   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

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:   2007-10
First Received:   August 1, 2007
Last Updated:   May 27, 2008
ClinicalTrials.gov Identifier:   NCT00511264
Health Authority:   Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Laparoscopy  
Ultrasound  
Cancer  
Biopsy  

Study placed in the following topic categories:
Liver Diseases
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Pancreatic Neoplasms
Liver neoplasms
Endocrine System Diseases
Stomach cancer
Liver Neoplasms
Digestive System Diseases
Stomach Diseases
Stomach Neoplasms
Head and Neck Neoplasms
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Esophageal Diseases
Esophageal neoplasm
Hepatocellular carcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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