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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00511264
First received: August 1, 2007
Last updated: May 27, 2008
Last verified: May 2008

August 1, 2007
May 27, 2008
May 2007
May 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00511264 on ClinicalTrials.gov Archive Site
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Laparoscopic Ultrasound Guided Tissue Sampling in Patients With Cancer of the Upper Gastrointestinal Tract
Prospective Evaluation of the Impact of Laparoscopic Ultrasound (LUS) Guided Fine-Needle Aspiration or Tru-Cut Biopsy in Patients With Upper GI Tract Cancer

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.

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Observational
Time Perspective: Prospective
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  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Liver Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients unfit for surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00511264
2007-10
No
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Odense University Hospital
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Principal Investigator: Michael B Mortensen, MD, Ph.D. Department of Surgery, Odense University Hospital
Odense University Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP