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

Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02397993
• Other study ID #: Helios 6/1/15
• Status: Recruiting
• Start date: March 2015
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Helios Albert-Schweitzer-Klinik Northeim
• Contact: Tobias Meister, PD Dr.
• Phone: +495551971244
• Email: tobias.meister[@]helios-kliniken.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Procedure:
• blood collection
blood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA
• fine needle aspiration
During endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas
• blood collection
blood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9

Locations

Country	Name	City	State
Germany	Department of Gastroenterology, Klinikum Bielefeld	Bielefeld	North-Rhine Westphalia
Germany	Department of Gastroenterology, University Medical Center	Göttingen	Lower Saxony
Germany	HELIOS Albert-Schweitzer Hospital Northeim	Northeim	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Helios Albert-Schweitzer-Klinik Northeim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lipase		up to 24h prior to EUS-FNA and 4 hours after EUS-FNA
Secondary	Serum amylase		up to 24 hours prior to EUS-FNA
Secondary	Serum amylase		4 hours after EUS-FNA
Secondary	CA 19-9		up to 24 hours prior to EUS-FNA
Secondary	CA 19-9		4 hours after EUS-FNA