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

This study has been completed.
Information provided by:
Odense University Hospital Identifier:
First received: August 1, 2007
Last updated: May 27, 2008
Last verified: May 2008

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.

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)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00511264

Department of Surgery, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Michael B Mortensen, MD, Ph.D. Department of Surgery, Odense University Hospital
  More Information Identifier: NCT00511264     History of Changes
Other Study ID Numbers: 2007-10
Study First Received: August 1, 2007
Last Updated: May 27, 2008

Keywords provided by Odense University Hospital:

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
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 processed this record on September 21, 2017