Somatostatin, Octreotide, Pentoxyfilline in the Preventio... | NCT00222092

Studies
Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers

NCT00222092

Sponsor

University of Ioannina

Status

Completed

Last Update Posted

Aug 24, 2011Estimated

Enrollment

300

Phase

Not provided

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Not provided

Countries

Greece

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 2005Estimated

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 23, 2011

Last Update Posted Date

Aug 24, 2011Estimated

Description Module

Brief Summary

Octreotide, somatostatin and pentoxyfilline commercially available drugs that are used in various clinical situations. They are safe and known for years. Octreotide and somatostatin have been used in many studies for the prophylaxis and treatment of pancreatitis and post-ERCP pancreatitis, while pentoxyfilline has shown effect on patients with alcoholic hepatitis, obstructive vasculitis etc. The aim of the study is to evaluate the efficacy of any of those treatments for the prophylaxis and treatment of post-ERCP pancreatitis. In addition some molecular markers of acute and chronic inflammation will be measured before and after the endoscopic procedures according to the study protocol.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

300

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion Criteria:

children, pregnant or breastfeeding women
patients with coagulation disorders
inability to access the papilla of Vater due to technical difficulties (previous surgery, malignant obstruction)

Accepts Healthy Volunteers

Yes

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

patients undergoing endoscopic retrograde cholangiopancreatography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dimitrios Sigounas, MD	University of Ioannina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hepato-Gastroenterology Unit, Medical School of Ioannina - Greece		Ioannina		45110	Greece