Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
1 other identifier
interventional
491
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedOctober 19, 2020
October 1, 2013
5.2 years
September 17, 2013
October 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the prevention of post-ERCP pancreatitis
one day
Study Arms (2)
ERCP & Thoracic epidural analgesia
EXPERIMENTALUsed thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP.
ERCP & Premedication
ACTIVE COMPARATORUsed Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP.
Interventions
Endoscopic retrograde cholangiopancreatography balloon dilatation
Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
For premedication used trimeperidine 2%-1ml intravenously.
Eligibility Criteria
You may qualify if:
- Patients with performed therapeutic ERCP;
- The ERCP procedure was performed in a patient for the first time;
- Prior to the ERCP procedure the patient didn't have any clinical signs of acute pancreatitis.
You may not qualify if:
- \- Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic №1 of Volgograd State Medical University
Volgograd, 400079, Russia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mihail Turovets, PhD
Clinic №1 of Volgograd state medical university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2013
First Posted
October 17, 2013
Study Start
January 1, 2008
Primary Completion
March 1, 2013
Study Completion
September 1, 2013
Last Updated
October 19, 2020
Record last verified: 2013-10