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

H

Helios Albert-Schweitzer-Klinik Northeim

Status

Unknown

Conditions

Pancreatitis

Treatments

Procedure: blood collection
Procedure: fine needle aspiration

Study type

Observational

Funder types

Other

Identifiers

NCT02397993
Helios 6/1/15

Details and patient eligibility

About

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.

Enrollment

208 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

208 participants in 1 patient group

FNA, blood collection
Description:
blood collection prior to fine needle aspiration Endoscopic ultrasonography-guided fine needle aspiration of the pancreas blood collection after to fine needle aspiration
Treatment:
Procedure: blood collection
Procedure: blood collection
Procedure: fine needle aspiration

Trial contacts and locations

3

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Central trial contact

Tobias Meister, PD Dr.

Data sourced from clinicaltrials.gov

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