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

This study has been completed.

First Received on August 1, 2007. Last Updated on May 27, 2008 History of Changes

Sponsor:	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

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:

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

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Odense University Hospital:

Laparoscopy
Ultrasound
Cancer
Biopsy

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Liver Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms

Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Liver Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 13, 2012