Lymph NodesNCT01033695
Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes
An observational study of Lymph Nodes and Esophageal Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymph Nodes, Esophageal Cancer, Gastric Cancer
- How many people
- 74 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for EUS examination on the basis of a malignant indication.
Who may be able to join
- the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination
Who cannot join
- inadequate ES images were obtained by one of the observers
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When planning the optimal therapy in patients with upper gastrointestinal malignancies it is essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has been added to conventional EUS examination and may provide complementary information to distinguish benign for malignant lymph nodes.
The N-stage relates to the treatment choice and the prognosis, and it is therefore of particular interest to know the interobserver agreement in operator dependent techniques. This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.
- Conditions
- Lymph Nodes, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Liver Cancer
- Keywords
- Endoscopy, Endoscopic Ultrasound, Endoscopic Sonoelastography, Cancer, Interobserver agreement
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph NodesStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 74 participants
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Michael H. Larsen, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033695
- Sponsor's protocol ID
- 12-2009
- Status last verified
- Aug 2009
- First submitted
- 15 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes
- ClinicalTrials.gov ID
- NCT01033695
- Acronym / sponsor ID
- 12-2009
- Conditions
- Lymph Nodes, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer, Liver Cancer
- Keywords
- Endoscopy, Endoscopic Ultrasound, Endoscopic Sonoelastography, Cancer, Interobserver agreement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When planning the optimal therapy in patients with upper gastrointestinal malignancies it is essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has been added to conventional EUS examination and may provide complementary information to distinguish benign for malignant lymph nodes.
The N-stage relates to the treatment choice and the prognosis, and it is therefore of particular interest to know the interobserver agreement in operator dependent techniques. This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for EUS examination on the basis of a malignant indication.
Key inclusion criteria (1 listed)
- the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination
Key exclusion criteria (1 listed)
- inadequate ES images were obtained by one of the observers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H. Larsen, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Nodes and Esophageal Cancer, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2009.