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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatitis
• Intervention / Treatment: Procedure: blood collection; Procedure: fine needle aspiration; Procedure: blood collection

• Study Type: Observational
• Enrollment (Anticipated): 208

Contacts and Locations

• Study Contact: Name: Tobias Meister, PD Dr.; Phone Number: +495551971244; Email: tobias.meister@helios-kliniken.de

Study Locations

• Germany
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Recruiting
      • Department of Gastroenterology, University Medical Center
    • Northeim, Lower Saxony, Germany, 37154
      • Recruiting
      • HELIOS Albert-Schweitzer Hospital Northeim
  • North-Rhine Westphalia
    • Bielefeld, North-Rhine Westphalia, Germany, 33604
      • Recruiting
      • Department of Gastroenterology, Klinikum Bielefeld
      • Contact: Jan Heidemann, PD Dr.; Phone Number: +495215813451; Email: info@klinikumbielefeld.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum lipase	up to 24h prior to EUS-FNA and 4 hours after EUS-FNA

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum amylase	up to 24 hours prior to EUS-FNA
Serum amylase	4 hours after EUS-FNA
CA 19-9	up to 24 hours prior to EUS-FNA
CA 19-9	4 hours after EUS-FNA

Collaborators and Investigators

• Sponsor: Helios Albert-Schweitzer-Klinik Northeim
• Investigators: Principal Investigator: Tobias Meister, PD Dr., HELIOS Albert-Schweitzer-Klinik; Principal Investigator: Jan Heidemann, PD Dr., Klinikum Bielefeld; Principal Investigator: Volker Ellenrieder, Prof. Dr., University Medical Center Göttingen

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 15, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 10, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: Helios 6/1/15