Diagnostic and Interventional Therapy in Acute Pancreatitis | NCT00699933

Studies
Diagnostic and Interventional Therapy in Acute Pancreatitis

NCT00699933

Sponsor

University of Regensburg

Status

Unknown status

Last Update Posted

Aug 9, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Acute Pancreatitis

Interventions

CT-guided percutaneous drainage technique

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 17, 2008

First Posted Date

Jun 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2011

Last Update Posted Date

Aug 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

For laboratory values different inflammation markers were measured and compared.

Conditions Module

Conditions

Acute Pancreatitis

Keywords

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Evaluation of one study cohort	Other: CT-guided percutaneous drainage technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-guided percutaneous drainage technique	Other	Evaluation of different diagnostics and evaluation of outcome of patients who received percutaneous CT-guided drainage for necrotic debridement and analyze the further outcome

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of hospital stay		weekly

Secondary Outcomes

Measure	Description	Time Frame
time to surgery		weekly
active necrosectomy		weekly
ICU stay

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

50 patients with acute pancreatitis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tanja Bruennler, Dr. med.	Contact	+49-941-944	7010	tanja.bruennler@klinik.uni-r.de

Overall Officials

Name	Affiliation	Role
Jürgen Schölmerich, Prof.	Director of Department of Internal Medicine I	Study Director
Stefan Feuerbach, Prof.	Director of Department of Radiology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Internal medicine I, University of Regensburg	Recruiting	Regensburg		93053	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided