Pancreatic MassNCT01437410
Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation
An observational study of Pancreatic Mass and Peripancreatic Mass, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of this retrospective single center study was to evaluate the clinical utility of histological and immunohistochemical analyses of specimens obtained by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pancreatic Mass, Peripancreatic Mass
- What is being tested?
- EUS-FNA
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jul 2010
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010 in Samsung Medical Center,
Who may be able to join
- We retrospectively reviewed medical records of patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010
Who cannot join
- Patients with unavailable data
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this retrospective single center study was to evaluate the clinical utility of histological and immunohistochemical analyses of specimens obtained by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA).
- Conditions
- Pancreatic Mass, Peripancreatic Mass
- Being tested
- EUS-FNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNAProcedure or surgery
tissue samples were harvested from 116 patients undergoing EUS-FNA of solid masses for cytologic smear and histological analysis.
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA | Not described Receives: Procedure: EUS-FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic accuracy of cytology, histology, and combined analysis of specimens obtained by EUS-FNA for pancreatic or peripancreatic solid masses
The first, pre-op checked each diagnostic accuracy of cytology, histology, and combined analysis by EUS-FNA. and then, finaly diagnosis following surgery or clinical follow up for at least 6 months was re-check with diagnosic accuracy of cytology, histology, and combined analysis pre-diagnosed by EUS-FNA
Measured: at least 6 months after surgery or clinical follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startJan 2009
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic MassStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437410
- Sponsor's protocol ID
- 2011-01-044
- Status last verified
- Sep 2011
- First submitted
- 9 Sep 2011
- Last updated
- 20 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation
- ClinicalTrials.gov ID
- NCT01437410
- Acronym / sponsor ID
- 2011-01-044
- Conditions
- Pancreatic Mass, Peripancreatic Mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 20 Sep 2011 (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.
The aim of this retrospective single center study was to evaluate the clinical utility of histological and immunohistochemical analyses of specimens obtained by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA | – | Procedure: EUS-FNA |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010 in Samsung Medical Center,
Key inclusion criteria (1 listed)
- We retrospectively reviewed medical records of patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010
Key exclusion criteria (1 listed)
- Patients with unavailable data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-FNAtissue samples were harvested from 116 patients undergoing EUS-FNA of solid masses for cytologic smear and histological analysis. | Procedure or surgery | EUS-FNA |
Primary outcome
the diagnostic accuracy of cytology, histology, and combined analysis of specimens obtained by EUS-FNA for pancreatic or peripancreatic solid masses
Time frame: at least 6 months after surgery or clinical follow up
The first, pre-op checked each diagnostic accuracy of cytology, histology, and combined analysis by EUS-FNA. and then, finaly diagnosis following surgery or clinical follow up for at least 6 months was re-check with diagnosic accuracy of cytology, histology, and combined analysis pre-diagnosed by EUS-FNA
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 20 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Mass and Peripancreatic Mass, run by Samsung Medical Center at 1 site in South Korea.
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 20 Sep 2011. 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 South Korea. 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.
What does the primary outcome measure?
the diagnostic accuracy of cytology, histology, and combined analysis of specimens obtained by EUS-FNA for pancreatic or peripancreatic solid masses (time frame: at least 6 months after surgery or clinical follow up). It is what the study was designed to measure, not a finding.
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 20 Sep 2011.