Clinical Trials Logo

Clinical Trial Summary

For 40 years, the post-ERCP (endoscopic retrograde cholangiopancreatography) pancreatitis has been the most frequent adverse effect of endoscopic transpapillary interventions. We sought to determine the efficacy of thoracic epidural analgesia for the prevention of post-ERCP pancreatitis. Between 2008 and 2013, a randomized study of the results of endoscopic treatment of 491 patients was conducted. The first group of patients (N=247) received thoracic epidural analgesia (TEA) during ERCP procedures, the patients of the second group (N=244) received a narcotic analgesic. To detect statistically significant differences between research groups adjusted odds ratios (OR) and their 95% confidence interval (CI) were calculated.


Clinical Trial Description

Preoperatively the subjects were randomly assigned (by using sealed envelopes - blind randomization) into two groups, 250 patients each. The patients of the first group had TEA applied during the ERCP procedure; other methods of pain relief were applied to the patients of the second (control) group. The first group (TEA group) of patients received the following premedication: atropine sulfate 0.5-1 mg, midazolan 5 mg. The puncture and catheterization of the epidural space was carried out according to standard procedure between thoracic vertebrae VII-VIII. Half an hour before performing ERCP ropivacaine 0.5% -10 ml. was injected into the epidural space. The second group (control group) of patients received the following premedication: atropine sulfate 0.5 -1 mg, midazolan 5 mg, trimeperidine 2% -1 ml. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01964066
Study type Interventional
Source Volgograd State Medical University
Contact
Status Completed
Phase N/A
Start date January 2008
Completion date September 2013

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 NCT02830984 - ENBD After Endoscopic Sphincterotomy Plus Large-balloon Dilation for Preventing PEP N/A
Recruiting NCT02839356 - Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis Phase 4
Completed NCT01673763 - Post-ERCP Pancreatitis Prevention by Stent Insertion N/A