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NCT00222092 Clinical Trial

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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:
Effect of Octreotide, Somatostatin, Pentoxyfilline or Placebo in the Prevention and the Course of Post-ERCP Pancreatitis and Study of Molecular Markers in Post-ERCP Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00222092
Other study ID # SIG-2005
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated August 23, 2011
Start date September 2005
Est. completion date September 2006

Study information
Verified date September 2005
Source University of Ioannina
Contact n/a
Is FDA regulated No
Health authority Greece: University of Ioannina - Greece
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Greece Hepato-Gastroenterology Unit, Medical School of Ioannina - Greece Ioannina

Sponsors (1)
Lead Sponsor Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

See also
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Completed NCT03098082 - Urine Trypsinogen 2 Dipstick for the Early Detection of Post-ERCP Pancreatitis N/A
Recruiting NCT02839356 - Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis Phase 4
Recruiting NCT02830984 - ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP N/A
Completed NCT01673763 - Post-ERCP Pancreatitis Prevention by Stent Insertion N/A
Active, not recruiting NCT04425993 - Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention N/A