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

NCT02397993 | Unknown

• 1 other identifier: Helios 6/1/15
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 3

Brief 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

Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Serum lipase

  up to 24h prior to EUS-FNA and 4 hours after EUS-FNA

Secondary Outcomes (4)

• 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

Study Arms (1)

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; Procedure: fine needle aspiration

Interventions

blood collection PROCEDURE

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

FNA, blood collection

fine needle aspiration PROCEDURE

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

FNA, blood collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helios Albert-Schweitzer-Klinik Northeim: lead

Study Sites (3)

Department of Gastroenterology, University Medical Center

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

HELIOS Albert-Schweitzer Hospital Northeim

Northeim, Lower Saxony, 37154, Germany

RECRUITING

Department of Gastroenterology, Klinikum Bielefeld

Bielefeld, North Rhine-Westphalia, 33604, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Pancreatic cells obtained by fine needle aspiration during endosonography Blood samples prior and after EUS with a assessment of CA19-9, Lipase and Amylase

MeSH Terms

Conditions

Pancreatitis

Interventions

Blood Specimen Collection; Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Meister, PD Dr.

CONTACT

+495551971244; tobias.meister@helios-kliniken.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

DE (3)