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UnknownNCT02397993

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

Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas

Status
Unknown
Phase
Study type
Observational
Enrollment
208 (estimated)
Sponsor
Helios Albert-Schweitzer-Klinik Northeim · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
PROCEDUREblood collectionblood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA
PROCEDUREfine needle aspirationDuring endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas
PROCEDUREblood collectionblood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9

Timeline

Start date
2015-03-01
Primary completion
2019-12-01
Completion
2020-12-01
First posted
2015-03-25
Last updated
2019-02-12

Locations

3 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT02397993. Inclusion in this directory is not an endorsement.