Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-04-10 @ 4:56 AM
Study NCT ID:
NCT02397993
Status:
UNKNOWN
Last Update Posted:
2019-02-12
First Post:
2015-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Pancreatic cells obtained by fine needle aspiration during endosonography Blood samples prior and after EUS with a assessment of CA19-9, Lipase and Amylase'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-10', 'studyFirstSubmitDate': '2015-03-15', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum lipase', 'timeFrame': 'up to 24h prior to EUS-FNA and 4 hours after EUS-FNA'}], 'secondaryOutcomes': [{'measure': 'Serum amylase', 'timeFrame': 'up to 24 hours prior to EUS-FNA'}, {'measure': 'Serum amylase', 'timeFrame': '4 hours after EUS-FNA'}, {'measure': 'CA 19-9', 'timeFrame': 'up to 24 hours prior to EUS-FNA'}, {'measure': 'CA 19-9', 'timeFrame': '4 hours after EUS-FNA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatitis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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 .\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* independent indication for pancreatic EUS-FNA\n* age ≥ 18 years\n* patient able to give informed consent\n\nExclusion Criteria:\n\n* Contraindications for EUS-FNA\n* pregnancy\n* no informed consent available\n* known stenosis of esophagus or duodenum\n* relevant coagulation disorders'}, 'identificationModule': {'nctId': 'NCT02397993', 'briefTitle': 'Serum Parameter Prior and After EUS-guided Fine Needle Aspiration of the Pancreas', 'organization': {'class': 'OTHER', 'fullName': 'Helios Albert-Schweitzer-Klinik Northeim'}, 'officialTitle': 'Serum Lipase, Amylase and CA 19-9 Prior and After EUS-guided Fine Needle Aspiration of the Pancreas', 'orgStudyIdInfo': {'id': 'Helios 6/1/15'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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', 'interventionNames': ['Procedure: blood collection', 'Procedure: fine needle aspiration']}], 'interventions': [{'name': 'blood collection', 'type': 'PROCEDURE', 'description': 'blood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA', 'armGroupLabels': ['FNA, blood collection']}, {'name': 'fine needle aspiration', 'type': 'PROCEDURE', 'description': 'During endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas', 'armGroupLabels': ['FNA, blood collection']}, {'name': 'blood collection', 'type': 'PROCEDURE', 'description': 'blood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9', 'armGroupLabels': ['FNA, blood collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Volker Ellenrieder, Professor', 'role': 'CONTACT', 'email': 'Volker.Ellenrieder@med.uni-goettingen.de', 'phone': '+49551390'}], 'facility': 'Department of Gastroenterology, University Medical Center', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '37154', 'city': 'Northeim', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tobias Meister, PDDr.med.', 'role': 'CONTACT', 'email': 'tobias.meister@helios-kliniken.de', 'phone': '+495551971244'}], 'facility': 'HELIOS Albert-Schweitzer Hospital Northeim', 'geoPoint': {'lat': 51.70662, 'lon': 9.99997}}, {'zip': '33604', 'city': 'Bielefeld', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan Heidemann, PD Dr.', 'role': 'CONTACT', 'email': 'info@klinikumbielefeld.de', 'phone': '+495215813451'}], 'facility': 'Department of Gastroenterology, Klinikum Bielefeld', 'geoPoint': {'lat': 52.03333, 'lon': 8.53333}}], 'centralContacts': [{'name': 'Tobias Meister, PD Dr.', 'role': 'CONTACT', 'email': 'tobias.meister@helios-kliniken.de', 'phone': '+495551971244'}], 'overallOfficials': [{'name': 'Tobias Meister, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helios Albert-Schweitzer-Klinik'}, {'name': 'Jan Heidemann, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum Bielefeld'}, {'name': 'Volker Ellenrieder, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Göttingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helios Albert-Schweitzer-Klinik Northeim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}