Diagnostic and Interventional Therapy in Acute Pancreatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Regensburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT00699933
First received: June 13, 2008
Last updated: August 8, 2011
Last verified: June 2010
  Purpose

The study aims to evaluate the course of patients with acute pancreatitis. Thereby we analyze different diagnostics and compare ultrasound, MRI and CT-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. Laboratory values were assessed as well.


Condition Intervention
Acute Pancreatitis
Other: CT-guided percutaneous drainage technique

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Interventional Therapy in Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to surgery [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • active necrosectomy [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • ICU stay [ Time Frame: weekly ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Bacterial DNA


Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Evaluation of one study cohort
Other: CT-guided percutaneous drainage technique
Evaluation of different diagnostics and evaluation of outcome of patients who received percutaneous CT-guided drainage for necrotic debridement and analyze the further outcome

Detailed Description:

For laboratory values different inflammation markers were measured and compared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

50 patients with acute pancreatitis

Criteria

Inclusion Criteria:

  • Age > 18 years
  • Acute pancreatitis
  • Written formal consent

Exclusion Criteria:

  • Pregnancy
  • Missing formal consent
  • Individual contraindications for CT-scan
  • MRI or endoscopic ultrasound
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699933

Contacts
Contact: Tanja Bruennler, Dr. med. +49-941-944 ext 7010 tanja.bruennler@klinik.uni-r.de

Locations
Germany
Department of Internal medicine I, University of Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Tanja Bruennler, Dr. med.    +43-941-944 ext 7010    tanja.bruennler@klinik.uni-r.de   
Principal Investigator: Tanja Bruennler, Dr. med.         
Sponsors and Collaborators
University of Regensburg
Investigators
Study Director: Jürgen Schölmerich, Prof. Director of Department of Internal Medicine I
Study Director: Stefan Feuerbach, Prof. Director of Department of Radiology
  More Information

No publications provided

Responsible Party: Dr. Tanja Brünnler, University of Regensburg
ClinicalTrials.gov Identifier: NCT00699933     History of Changes
Other Study ID Numbers: 08/008
Study First Received: June 13, 2008
Last Updated: August 8, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Regensburg:
acute pancreatitis
interventional therapy
CT-guided drainage therapy
percutaneous necrosectomy
Comparison of different diagnostic procedures: MRI, CT, Ultrasound
Evaluation of interventional therapy including percutaneous drainage techniques und necrosectomies

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 30, 2014