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

NCT02397993 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 208

Last updated 2019-02-12

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

blood collection

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

PROCEDURE

fine needle aspiration

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

PROCEDURE

blood collection

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

Sponsors & Collaborators

  • Helios Albert-Schweitzer-Klinik Northeim

    lead OTHER

Principal Investigators

  • Tobias Meister, PD Dr. · Helios Albert-Schweitzer-Klinik

  • Jan Heidemann, PD Dr. · Klinikum Bielefeld

  • Volker Ellenrieder, Prof. Dr. · University Medical Center Göttingen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02397993 on ClinicalTrials.gov