Post-ERCP Acute PancreatitisNCT01964066
Study of Effectiveness of Thoracic Epidural Analgesia for the Prevention of Acute Pancreatitis After ERCP Procedures
A study testing ERCP, Thoracic epidural analgesia and Premedication in people with Post-ERCP Acute Pancreatitis, run by Volgograd State Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 15 to 92 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- ERCP, Thoracic epidural analgesia and Premedication
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 491 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2008to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 92 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
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.
Read the detailed 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.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- ERCP, Thoracic epidural analgesia, Premedication
- Keywords
- therapeutic ERCP, prevention of post-ERCP pancreatitis, thoracic epidural analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Also called endoscopic transpapillary intervention
Endoscopic retrograde cholangiopancreatography balloon dilatation
Thoracic epidural analgesiaProcedure or surgery
Also called Epidural analgesia, Epidural anaesthesia
Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
PremedicationProcedure or surgery
Also called anociassociation, anocithesia, prenarcosis
For premedication used trimeperidine 2%-1ml intravenously.
| Study group | Role | What they receive |
|---|---|---|
| ERCP & Thoracic epidural analgesia | Experimental | Used thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP. Receives: Procedure: ERCP; Procedure: Thoracic epidural analgesia |
| ERCP & Premedication | Active comparator | Used Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP. Receives: Procedure: ERCP; Procedure: Premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevention of post-ERCP pancreatitis
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJan 2008
- Primary completionMar 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-ERCP Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 491 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volgograd State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihail Turovets, PhD, Study chair, Clinic №1 of Volgograd state medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964066
- Sponsor's protocol ID
- 124/2007/12/24
- Status last verified
- Oct 2013
- First submitted
- 17 Sep 2013
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thoracic Epidural Analgesia for the Prevention of Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT01964066
- Acronym / sponsor ID
- 124/2007/12/24
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- therapeutic ERCP, prevention of post-ERCP pancreatitis, thoracic epidural analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants (actual)
- Lead sponsor
- Volgograd State Medical UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERCP & Thoracic epidural analgesia | Experimental | Procedure: ERCP, Procedure: Thoracic epidural analgesiaUsed thoracic epidural analgesia (ropivacaine 0.5% -10ml) for pain relief ERCP. |
| ERCP & Premedication | Active comparator | Procedure: ERCP, Procedure: PremedicationUsed Premedication (trimeperidine 2% -1ml intravenously) for pain control ERCP. |
Who may qualify
- Ages
- 15 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Development of complications during the ERCP procedure that required urgent surgical intervention (massive haemorrhage, Dormia basket avulsion and others).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPAlso: endoscopic transpapillary interventionEndoscopic retrograde cholangiopancreatography balloon dilatation | Procedure or surgery | ERCP & Premedication, ERCP & Thoracic epidural analgesia |
| Thoracic epidural analgesiaAlso: Epidural analgesia, Epidural anaesthesiaThoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml) | Procedure or surgery | ERCP & Thoracic epidural analgesia |
| PremedicationAlso: anociassociation, anocithesia, prenarcosisFor premedication used trimeperidine 2%-1ml intravenously. | Procedure or surgery | ERCP & Premedication |
Primary outcome
the prevention of post-ERCP pancreatitis
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Related trials for Post-ERCP Acute Pancreatitis
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Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
Acute Biliary Pancreatitis
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Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis
Pancreatitis, Acute
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An European Multi-centre Cohort Study for Unravelling Pharmacokinetic and Genetic Factors Underlying Post-ERCP Pancreatitis
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Indomethacin for Biliary ERCP Patients
Pancreatitis Biliary, Pancreatitis Acute Biliary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihail Turovets, PhD study chair
Clinic №1 of Volgograd state medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP, Thoracic epidural analgesia and Premedication in people with Post-ERCP Acute Pancreatitis, run by Volgograd State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevention of post-ERCP pancreatitis (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.