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

NCT ID: NCT00511264

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer Gastric Cancer Pancreatic Cancer Liver Cancer

Keywords

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Laparoscopy Ultrasound Cancer Biopsy

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients unfit for surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Michael B Mortensen, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Odense University Hospital

Locations

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Department of Surgery, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2007-10

Identifier Type: -

Identifier Source: org_study_id