Evaluation of Preoperative Investigations in Patients Wit... | NCT00408122

Studies
Evaluation of Preoperative Investigations in Patients With Liver Cancer

NCT00408122

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Oct 16, 2014Estimated

Enrollment

77Actual

Phase

Not provided

Conditions

Primary Liver Cancer
Liver Metastasis

Interventions

PET/CT scan and EUS

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Dec 5, 2006

First Submission Date that Met QC Criteria

Dec 5, 2006

First Posted Date

Dec 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2014

Last Update Posted Date

Oct 16, 2014Estimated

Description Module

Brief Summary

The aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a CT scan (PET/CT) and endoscopic ultrasonography (EUS) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Name	Type	Description	Arm Group Labels	Other Names
PET/CT scan and EUS	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients who are referred to The Department of Surgery, Odense University Hospital, for surgical treatment of suspected or biopsy proven primary or secondary liver cancer.

Exclusion Criteria:

age less than 18 years
patients who are not fit for liver surgery because of co-morbidity
patients for whom the extra investigations in the study are considered to give an increased risk because of co-morbidity such as
- Patients with s-creatinin > 150 micromol/l
- Patients who take peroral antidiabetic drugs or have a poorly regulated diabetes mellitus
patients who do not understand the patient information
patients who do not want to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

PAtients with liver tumors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henning O Nielsen, MD, DMsc	dept. of Surgery, Odense University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Surgery, Odense university Hospital		Odense		5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided