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Status unknownNCT02397993Updated Feb 12, 2019

Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas

An observational study in Pancreatitis, sponsored by Helios Albert-Schweitzer-Klinik Northeim. Status unknown at 3 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-12.

Sponsored by Helios Albert-Schweitzer-Klinik Northeim · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
208
Ages
18 Years and older
Sex
All
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Study 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.

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.

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Conditions studied

  • Pancreatitis

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In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 208 is above the median of 180 across 277 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Helios Albert-Schweitzer-Klinik Northeim is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Inclusion criteria

  • independent indication for pancreatic EUS-FNA
  • age ≥ 18 years
  • patient able to give informed consent

Exclusion criteria

Exclusion Criteria:

  • Contraindications for EUS-FNA
  • pregnancy
  • no informed consent available
  • known stenosis of esophagus or duodenum
  • relevant coagulation disorders
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
208 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

    Procedure: blood collection · Procedure: fine needle aspiration

Interventions

  • Procedureblood collection

    blood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA

  • Procedurefine needle aspiration

    During endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas

  • Procedureblood collection

    blood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9

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What researchers measure

Primary outcomes

  1. Serum lipase

    Time frame: up to 24h prior to EUS-FNA and 4 hours after EUS-FNA

Secondary outcomes

  1. Serum amylase

    Time frame: up to 24 hours prior to EUS-FNA

  2. Serum amylase

    Time frame: 4 hours after EUS-FNA

  3. CA 19-9

    Time frame: up to 24 hours prior to EUS-FNA

  4. CA 19-9

    Time frame: 4 hours after EUS-FNA

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Study locations

3 of 3 sites recruiting
  • Department of Gastroenterology, University Medical Center
    Göttingen, Lower Saxony 37075, Germany
    Recruiting
  • HELIOS Albert-Schweitzer Hospital Northeim
    Northeim, Lower Saxony 37154, Germany
    Recruiting
  • Department of Gastroenterology, Klinikum Bielefeld
    Bielefeld, North-Rhine Westphalia 33604, Germany
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02397993
Lead sponsor
Helios Albert-Schweitzer-Klinik Northeim
Responsible party
Sponsor
First posted
Mar 25, 2015
Start date
Mar 2015
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Feb 12, 2019

Study contacts

Tobias Meister, PD Dr.
Contact
tobias.meister@helios-kliniken.de
+495551971244
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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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