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NCT00511264 Clinical Trial

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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00511264
Other study ID # 2007-10
Secondary ID
Status Completed
Phase N/A
First received August 1, 2007
Last updated May 27, 2008
Start date May 2007
Est. completion date May 2008

Study information
Verified date May 2008
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Biopsy proven upper GI tract cancer

- Laparoscopic Ultrasound indicated during pre-treatment evaluation

Exclusion Criteria:

- Patients unfit for surgery

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Surgery, Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

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