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NCT01673763 Clinical Trial

Post-ERCP Pancreatitis Prevention by Stent Insertion

Post-ERCP Acute Pancreatitis Clinical Trial

— PEPSI  

Official title:
Study to Reduce Incidence of Post-ERCP Pancreatitis by Stent Insertion in the Main Pancreatic Duct After Unintended Cannulation of the Main Pancreatic Duct

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01673763
Other study ID # 240179
Secondary ID
Status Completed
Phase N/A
First received October 17, 2011
Last updated October 11, 2017
Start date July 2010
Est. completion date August 2017

Study information
Verified date October 2017
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.

Recruitment information / eligibility
Status Completed
Enrollment 169
Est. completion date August 2017
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct

- age > 17 years

- signed informed consent

Exclusion Criteria:

- intention to intervene main pancreatic duct

- age < 18 years

- pregnancy

- absent of signed informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Stent insertion into the main pancreatic duct
Stent insertion into the main pancreatic duct

Locations
Country Name City State
Belgium Deptartment of Hepatobiliary Diseases Leuven University Hospitals Leuven
Germany Klinikum rechts der Isar, Technische Universität München Munich
Latvia P. Stradin Clinical University Hospital Gastroenterology Centere Latvijas Universitates Medicinas Riga
Russian Federation First city hospital of emergency care Northern State Medical University Arkhangelsk

Sponsors (4)
Lead Sponsor Collaborator
Technische Universität München Katholieke Universiteit Leuven, Latvijas Universitates Medicinas, Northern State University, Russia

Countries where clinical trial is conducted

Belgium,  Germany,  Latvia,  Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of post-ERCP pancreatitis up to 1 week
See also
  Status Clinical Trial Phase
Completed NCT04546867 - Establishing a Sonographic Based Algorithm to Verify Pancreatic Stent Position Placed to Prevent Post-ERCP Pancreatitis Before Endoscopic Removal N/A
Terminated NCT02241512 - IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis Phase 2
Completed NCT00222092 - Somatostatin, Octreotide, Pentoxyfilline in the Prevention of Post-ERCP Pancreatitis and Molecular Markers Phase 4
Completed NCT05310409 - PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms
Not yet recruiting NCT06260878 - Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis Phase 4
Not yet recruiting NCT04770857 - Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis
Completed NCT02641561 - Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis Phase 3
Active, not recruiting NCT04145336 - 7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients N/A
Completed NCT03629600 - Trial of Aggressive Hydration Versus Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis Phase 2/Phase 3
Recruiting NCT03756116 - Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide N/A
Recruiting NCT05664074 - Rectal Indomethacin vs Intravenous Ketorolac Phase 4
Completed NCT02308891 - A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis N/A
Recruiting NCT05336630 - Study of Forceps Cannulation During ERCP N/A
Recruiting NCT05857514 - Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis N/A
Recruiting NCT05267379 - An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
Recruiting NCT05947461 - Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac N/A
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
Active, not recruiting NCT04425993 - Rectal Indomethacin Versus Rectal Indomethacin and Sublingual Nitrate for PEP Prevention N/A

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