PancreatitisNCT02397993
Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
An observational study of Pancreatitis, run by Helios Albert-Schweitzer-Klinik Northeim at 3 sites in Germany.
Trial summary
Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- blood collection and fine needle aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 208 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2015to Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with independent indication for endoscopic ultrasound-guided fine needle aspiration of the pancreas due to pancreatic disease (e.g. pancreatitis, pancreatic masses) no volunteers accepted
Who may be able to join
- independent indication for pancreatic EUS-FNA
- age ≥ 18 years
- patient able to give informed consent
Who cannot join
- Contraindications for EUS-FNA
- pregnancy
- no informed consent available
- known stenosis of esophagus or duodenum
- relevant coagulation disorders
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
Department of Gastroenterology, Klinikum Bielefeld
Bielefeld, North Rhine-Westphalia, 33604
Jan Heidemann, PD Dr., +495215813451, info@klinikumbielefeld.de
- Recruiting
Department of Gastroenterology, University Medical Center
Göttingen, Lower Saxony, 37075
Volker Ellenrieder, Professor, +49551390, Volker.Ellenrieder@med.uni-goettingen.de
- Recruiting
HELIOS Albert-Schweitzer Hospital Northeim
Northeim, Lower Saxony, 37154
Tobias Meister, PDDr.med., +495551971244, tobias.meister@helios-kliniken.de
About this study
Official title: Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
Endoscopic ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine.
The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all three parameters was observed after surgery on the pancreas. For humans, these clinically important data are not yet available .
It is assumed that the probability of pancreatitis with increased activity of lipase and amylase will rise with the number of puncture procedures as well as the size of the puncture needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could result in a false positive assumption of malignant neoplastic pancreatic lesion.
- Conditions
- Pancreatitis
- Being tested
- blood collection, fine needle aspiration
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionProcedure or surgery
blood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA
fine needle aspirationProcedure or surgery
During endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas
blood collectionProcedure or surgery
blood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9
| Study group | Role | What they receive |
|---|---|---|
| FNA, blood collection | blood collection prior to fine needle aspiration Endoscopic ultrasonography-guided fine needle aspiration of the pancreas blood collection after to fine needle aspiration Receives: Procedure: blood collection; Procedure: fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lipase
Measured: up to 24h prior to EUS-FNA and 4 hours after EUS-FNA
Secondary outcomes (4)
Serum amylase
Measured: up to 24 hours prior to EUS-FNA
Serum amylase
Measured: 4 hours after EUS-FNA
CA 19-9
Measured: up to 24 hours prior to EUS-FNA
CA 19-9
Measured: 4 hours after EUS-FNA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Albert-Schweitzer-Klinik Northeim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Meister, PD Dr., Principal investigator, Helios Albert-Schweitzer-KlinikJan Heidemann, PD Dr., Principal investigator, Klinikum BielefeldVolker Ellenrieder, Prof. Dr., Principal investigator, University Medical Center Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397993
- Sponsor's protocol ID
- Helios 6/1/15
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
- ClinicalTrials.gov ID
- NCT02397993
- Acronym / sponsor ID
- Helios 6/1/15
- Conditions
- Pancreatitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Helios Albert-Schweitzer-Klinik NortheimUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Mar 2015 (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 ultrasonography (EUS ) -guided fine needle aspiration (EUS -FNA ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine.
The aim of this study is to determine the levels of serum lipase, serum amylase and the tumor marker CA 19-9 prior and after EUS-FNA. In animal experiments on dogs, an increase of all three parameters was observed after surgery on the pancreas. For humans, these clinically important data are not yet available .
It is assumed that the probability of pancreatitis with increased activity of lipase and amylase will rise with the number of puncture procedures as well as the size of the puncture needle. In addition, the post-interventional assessment of the tumor marker CA 19-9 could result in a false positive assumption of malignant neoplastic pancreatic lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FNA, blood collection | – | Procedure: blood collection, Procedure: fine needle aspirationblood collection prior to fine needle aspiration Endoscopic ultrasonography-guided fine needle aspiration of the pancreas blood collection after to fine needle aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with independent indication for endoscopic ultrasound-guided fine needle aspiration of the pancreas due to pancreatic disease (e.g. pancreatitis, pancreatic masses) no volunteers accepted
Key inclusion criteria (3 listed)
- independent indication for pancreatic EUS-FNA
- age ≥ 18 years
- patient able to give informed consent
Key exclusion criteria (5 listed)
- Contraindications for EUS-FNA
- pregnancy
- no informed consent available
- known stenosis of esophagus or duodenum
- relevant coagulation disorders
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 |
|---|---|---|
| blood collectionblood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA | Procedure or surgery | FNA, blood collection |
| fine needle aspirationDuring endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas | Procedure or surgery | FNA, blood collection |
| blood collectionblood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9 | Procedure or surgery | FNA, blood collection |
Primary outcome
Serum lipase
Time frame: up to 24h prior to EUS-FNA and 4 hours after EUS-FNA
4 secondary outcomes
Serum amylase
Time frame: up to 24 hours prior to EUS-FNA
Serum amylase
Time frame: 4 hours after EUS-FNA
CA 19-9
Time frame: up to 24 hours prior to EUS-FNA
CA 19-9
Time frame: 4 hours after EUS-FNA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
Related trials for Pancreatitis
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
Tobias Meister, PD Dr. principal investigator
Helios Albert-Schweitzer-Klinik
Jan Heidemann, PD Dr. principal investigator
Klinikum Bielefeld
Volker Ellenrieder, Prof. Dr. principal investigator
University Medical Center Göttingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, run by Helios Albert-Schweitzer-Klinik Northeim at 3 sites in Germany.
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 5 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 Tobias Meister, PD Dr. (+495551971244, tobias.meister@helios-kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum lipase (time frame: up to 24h prior to EUS-FNA and 4 hours after EUS-FNA). 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 12 Feb 2019.