Pancreatic CystNCT02041897
Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions
A study testing EUS-FNA in people with Pancreatic Cyst, run by Xiaoyin Zhang at 1 site in China.
Trial summary
It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cyst
- What is being tested?
- EUS-FNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Jan 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with ages from 18-80 years old.
- The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm.
- Sign the informed consent voluntarily. -
Who cannot join
- The patient can't accept the endoscopic procedure.
- The patient has blood coagulation dysfunction.
- The patient has mental disorders.
- The patient has mild or severe cardiorespiratory insufficiency.
- The patient has hypertension and can't be controlled to safe level.
- Patients with alcohol dependence.
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- Pregnant and lactating women.
- The patients the investigators don't think suitable for this study.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology,Xijing Hospital
Xian, Shanxi, 710032
Xiaoyin Zhang, MD,Ph.D, 86-29-84771540, zhangxy@fmmu.edu.cn
Yan Pan, Master, 86-29-84771540, panpan@fmmu.edu.cn
About this study
Official title: Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions----A Multiple Center,Prospective Study
It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.
Read the detailed description
First, the investigators will send only EUS images of patients with PCL to diagnosis committee that is consisted with 8 EUS specialists from different countries.The diagnosis will be collected. Then the investigators send the results of EUS-FNA. The diagnosis and suggestions will be collected again. The investigators will calculate how much diagnosis has been changed because of results of EUS-FNA. The investigators will also follow up these patients for 5 years at least to find if these patients benefit from EUS-FNA and complications such as needle tract seeding metastases.
- Conditions
- Pancreatic Cyst
- Being tested
- EUS-FNA
- Keywords
- EUS-FNA, Pancreatic cystic lesion, Diagnosis
- Medical subject headings
- Pancreatic Cyst, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNAProcedure or surgery
Also called Endoscopic ultrasound guided fine needle aspiration with 22G needle.
Only one puncture will be performed. First the fluid will be aspirated out for biochemical analysis and cytology. Then the tissue will be aspirated out from the solid part of the lesion for pathology.
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA, Rate of chang on diagnosis | Other | It is a single arm study. We will conclude by calculating the rate of change of diagnosis before and after getting the results of EUS-FNA. Receives: Procedure: EUS-FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change of diagnosis
Finish diagnosis before and after getting the results of EUS-FNA
Measured: During 2 weeks
Secondary outcomes (1)
Number of Participants with Adverse Events
after EUS-FNA
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaoyin Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Second Military Medical University
- Responsible party
- Sponsor-investigator, Xiaoyin Zhang, Air Force Military Medical University, China
- Investigators
- Kaichun Wu, MD,Ph.D, Study chair, Xijing hospital,The Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041897
- Sponsor's protocol ID
- PCL-EUS-FNA
- Status last verified
- Jan 2014
- First submitted
- 14 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions----A Multiple Center,Prospective Study
- ClinicalTrials.gov ID
- NCT02041897
- Acronym / sponsor ID
- PCL-EUS-FNA
- Conditions
- Pancreatic Cyst
- Keywords
- EUS-FNA, Pancreatic cystic lesion, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Xiaoyin ZhangUniversity, hospital or other
- Collaborators
- Second Military Medical University
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 22 Jan 2014 (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.
It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.
Detailed description
First, the investigators will send only EUS images of patients with PCL to diagnosis committee that is consisted with 8 EUS specialists from different countries.The diagnosis will be collected. Then the investigators send the results of EUS-FNA. The diagnosis and suggestions will be collected again. The investigators will calculate how much diagnosis has been changed because of results of EUS-FNA. The investigators will also follow up these patients for 5 years at least to find if these patients benefit from EUS-FNA and complications such as needle tract seeding metastases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA, Rate of chang on diagnosis | Other | Procedure: EUS-FNAIt is a single arm study. We will conclude by calculating the rate of change of diagnosis before and after getting the results of EUS-FNA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with ages from 18-80 years old.
- The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm.
- Sign the informed consent voluntarily. -
Key exclusion criteria (9 listed)
- The patient can't accept the endoscopic procedure.
- The patient has blood coagulation dysfunction.
- The patient has mental disorders.
- The patient has mild or severe cardiorespiratory insufficiency.
- The patient has hypertension and can't be controlled to safe level.
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-FNAAlso: Endoscopic ultrasound guided fine needle aspiration with 22G needle.Only one puncture will be performed. First the fluid will be aspirated out for biochemical analysis and cytology. Then the tissue will be aspirated out from the solid part of the lesion for pathology. | Procedure or surgery | EUS-FNA, Rate of chang on diagnosis |
Primary outcome
Rate of change of diagnosis
Time frame: During 2 weeks
Finish diagnosis before and after getting the results of EUS-FNA
1 secondary outcome
Number of Participants with Adverse Events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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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.
Kaichun Wu, MD,Ph.D study chair
Xijing hospital,The Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-FNA in people with Pancreatic Cyst, run by Xiaoyin Zhang at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyin Zhang, MD,Ph.D (86-29-84771540, zhangxy@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change of diagnosis (time frame: During 2 weeks). 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 22 Jan 2014.