NCT00511264

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

August 1, 2007

Last Update Submit

May 27, 2008

Conditions

Esophageal CancerGastric CancerPancreatic CancerLiver Cancer

Keywords

LaparoscopyUltrasoundCancerBiopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsPancreatic NeoplasmsLiver NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesLiver Diseases

Study Officials

  • Michael B Mortensen, MD, Ph.D.

    Department of Surgery, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 3, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

DK(1)