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NCT04770857 Clinical Trial

Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis

Post-ERCP Acute Pancreatitis Clinical Trial

— PEP-PREPARE  

Official title:
Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04770857
Other study ID # CTU 19/036
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date August 2023

Study information
Verified date July 2021
Source Cantonal Hospital of St. Gallen
Contact Nicola Fabian Frei, MD
Phone +41 71 494 99 68
Email nicolafabian.frei@kssg.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%. Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP. This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date August 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >18 years - Scheduled for ERCP for any reason Exclusion Criteria: - Absence of consent - Language barrier - No endoscopic advance to the papilla vateri - Active pancreatitis at the time of the procedure - Mental disability

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Visual analogue scale
Post procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP

Locations
Country Name City State
Switzerland Kantonsspital Sankt Gallen Sankt Gallen

Sponsors (1)
Lead Sponsor Collaborator
Nicola Frei

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Association between Pain 1 hour after ERCP 1 hour
Secondary Predictive value of VAS for PEP Predictive value of VAS for PEP 1 hour
Secondary Association between VAS level and severity of PEP 1 hour
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
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
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