Post-ERCP Acute PancreatitisPhase 4NCT02839356
Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis
A Phase 4 study testing epinephrine and normal saline in people with Post-ERCP Acute Pancreatitis, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a well-recognized complication with significant morbidity and even mortality. A variety of possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema caused by manipulations during cannulation or… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- epinephrine and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Dec 2017
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age > 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
Who cannot join
- Pregnancy or history of allergy to epinephrine.
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
- Patients involved in other study within 60 days.
- Billroth II or Roux-en-Y anatomy
- Acute pancreatitis.
- All contraindications to epinephrine.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
Hefei, Anhui, 230001
Shao Feng, MD, 8613033090788, tagsmile1985@163.com
Shao Feng, MD
About this study
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a well-recognized complication with significant morbidity and even mortality. A variety of possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema caused by manipulations during cannulation or endoscopic treatment has received the most attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical application of epinephrine on the papilla may reduce papillary edema. Moreover, it is reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after endoscopic retrograde cholangiopancreatography. We therefore designed a prospective randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after ERCP.
Read the detailed description
Between July 2016 and December 2017, 670 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to undergo a spray of epinephrine (epinephrine group) or saline (control group) on the major papilla. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- epinephrine, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epinephrineDrug
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
normal salineDrug
20-mL irrigation with physiological saline over the entire papilla
| Study group | Role | What they receive |
|---|---|---|
| Drug: epinephrine | Experimental | 20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla Receives: Drug: epinephrine |
| Drug: normal saline | Placebo comparator | 20-mL irrigation with physiological saline over the entire papilla Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Measured: PEP occurence rate at 24 h after ERCP in two groups.
Secondary outcomes (1)
Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.
Hyperamylasemia will be defined as the serum amylase 3 times more than the upper normal values, without clinical symptoms. During the study, any unexpected medical issue will be called adverse event.
Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Measured: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shao Feng, MD, Study director, Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839356
- Sponsor's protocol ID
- Epinephrine001
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT02839356
- Acronym / sponsor ID
- Epinephrine001
- Conditions
- Post-ERCP Acute Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Jul 2016 (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.
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a well-recognized complication with significant morbidity and even mortality. A variety of possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema caused by manipulations during cannulation or endoscopic treatment has received the most attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical application of epinephrine on the papilla may reduce papillary edema. Moreover, it is reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after endoscopic retrograde cholangiopancreatography. We therefore designed a prospective randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after ERCP.
Detailed description
Between July 2016 and December 2017, 670 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to undergo a spray of epinephrine (epinephrine group) or saline (control group) on the major papilla. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: epinephrine | Experimental | Drug: epinephrine20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla |
| Drug: normal saline | Placebo comparator | Drug: normal saline20-mL irrigation with physiological saline over the entire papilla |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, age > 18 years.
- Normal amylase level before undergoing ERCP.
- Signed inform consent form and agreed to follow-up on time.
Key exclusion criteria (6 listed)
- Pregnancy or history of allergy to epinephrine.
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
- Patients involved in other study within 60 days.
- Billroth II or Roux-en-Y anatomy
- Acute pancreatitis.
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 |
|---|---|---|
| epinephrine20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla | Drug | Drug: epinephrine |
| normal saline20-mL irrigation with physiological saline over the entire papilla | Drug | Drug: normal saline |
Primary outcome
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis
Time frame: PEP occurence rate at 24 h after ERCP in two groups.
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables. Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
1 secondary outcome
Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.
Time frame: the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Shao Feng, MD study director
Department of General Surgery, Anhui Provincial Hospital Affiliated with Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epinephrine and normal saline in people with Post-ERCP Acute Pancreatitis, run by Anhui Provincial Hospital at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao Feng, MD (8613033090788, tagsmile1985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis (time frame: PEP occurence rate at 24 h after ERCP in two groups.). 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 3 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.