NCT00699933

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 9, 2011

Status Verified

June 1, 2010

Enrollment Period

4.6 years

First QC Date

June 13, 2008

Last Update Submit

August 8, 2011

Conditions

Acute Pancreatitis

Keywords

acute pancreatitisinterventional therapyCT-guided drainage therapypercutaneous necrosectomyComparison of different diagnostic procedures: MRI, CT, UltrasoundEvaluation of interventional therapy including percutaneous drainage techniques und necrosectomies

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    weekly

Secondary Outcomes (3)

  • time to surgery

    weekly

  • active necrosectomy

    weekly

  • ICU stay

    weekly

Study Arms (1)

1

Evaluation of one study cohort

Other: CT-guided percutaneous drainage technique

Interventions

CT-guided percutaneous drainage techniqueOTHER

Evaluation of different diagnostics and evaluation of outcome of patients who received percutaneous CT-guided drainage for necrotic debridement and analyze the further outcome

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients with acute pancreatitis

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Missing formal consent
  • Individual contraindications for CT-scan
  • MRI or endoscopic ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal medicine I, University of Regensburg

Regensburg, 93053, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Jürgen Schölmerich, Prof.

    Director of Department of Internal Medicine I

    STUDY DIRECTOR

  • Stefan Feuerbach, Prof.

    Director of Department of Radiology

    STUDY DIRECTOR

Central Study Contacts

Tanja Bruennler, Dr. med.

CONTACT

+49-941-944tanja.bruennler@klinik.uni-r.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 9, 2011

Record last verified: 2010-06

Locations

DE(1)