Post-ERCP Acute PancreatitisPhase 4PEIR-PEPNCT07173179
Papillary Epinephrine Injection vs Rectal Indomethacin
A Phase 4 study testing Epinephrine injection and Indomethacin in people with Post-ERCP Acute Pancreatitis, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common and one of the most undesirable major adverse events after endoscopic retrograde cholangiopancreatography (ERCP), causing significant morbidity and even mortality. 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 injection and Indomethacin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 May 2025
- 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
None listed.
Who cannot join
- Pregnancy
- Inability to provide written informed consent
- Previous history of ERCP
- Ampulla of Vater cancer
- Surgically altered anatomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University School of Medicine
Düzce, 81620
About this study
Official title: Papillary Undiluted Epinephrine Injection vs Rectal Indomethacin in Preventing Post-ERCP Pancreatitis (PEIR-PEP): A Prospective, Double-blind, Randomized Controlled Trial
Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common and one of the most undesirable major adverse events after endoscopic retrograde cholangiopancreatography (ERCP), causing significant morbidity and even mortality. The incidence rate is almost 15% in high-risk patients and no less than 3% in average-risk patients.
Many factors contribute to PEP, such as patient-related and endoscopist-related factors, but mainly two mechanisms are considered in terms of physiopathology: papillary edema caused by mechanical trauma during cannulation and thermal injury with electrocautery current.
Read more
Rectal NSAIDs and pancreatic stent placement are the two proven methods of PEP prophylaxis included in the guideline recommendations, but despite their frequent use, the incidence rates remain unacceptably high. There is a need for additional methods that are easy to implement, preferably low-cost, and safe to reduce the risk of PEP.
Topical epinephrine applied submucosally can meet these goals. Ampullary epinephrine injection is an effective method for post-sphincterotomy bleeding. Still, to our knowledge, no study has examined its efficacy in PEP prophylaxis, except for the retrospective study we reported.
There are conflicting reports on epinephrine spraying onto the papilla for PEP, but these trials are largely heterogeneous, with different dose regimens. It should also be noted that spraying epinephrine onto the papilla has a duration of action of about 1 to 5 minutes, whereas epinephrine injection has a duration of roughly 120 minutes.
Given this information, a large-scale, prospective, double-blind, randomized, controlled trial is designed.
Read the detailed description
Patients will be randomized into two groups: rectal indomethacin (Group A) and epinephrine injection (Group B), by computer-generated, numbered, sealed envelopes for treatment assignments. The envelopes will be opened before the procedure without the knowledge of the endoscopists to enable blinding in the randomization process
The patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure. The patients in Group B will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice
ERCP procedures will be performed under endoscopist-directed deep sedation. Blood pressure, pulse rate, and electrocardiography will be monitored in all patients during and after the procedure. Demographic data, laboratory values, procedure parameters, and adverse events will be recorded. All patients will be hospitalized for at least 24 hours.
Total procedure time is defined as the interval between esophageal intubation and duodenoscope extubation. Difficult biliary cannulation is defined as ≥5 contacts with the papilla and more than five minutes spent attempting cannulation after the first papillary contact. Cannulation time is defined as the interval between the initial contact of the sphincterotome with the ampullary mound and successful biliary cannulation. Post-ERCP adverse events will be recorded according to the American Society for Gastrointestinal Endoscopy (ASGE) ERCP lexicon. Serum samples will be obtained before the procedure and at four and 24 hours post-ERCP to measure complete blood cell counts, C-reactive protein (CRP), amylase, lipase, bilirubin, and liver enzymes. All patients will be invited for follow-up at 1 week and 1 month after the procedure.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- Epinephrine injection, Indomethacin
- Keywords
- ERCP, post-ercp acute pancreatitis, epinephrine, indomethacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine injectionProcedure or surgery
The patients will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice, at the end of the procedure, in 60 seconds
IndomethacinDrug
The patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure
| Study group | Role | What they receive |
|---|---|---|
| Rectal indomethacin | Active comparator | The patients will receive 100mg of rectal indomethacin alone, just before the procedure Receives: Drug: Indomethacin |
| Peripapillary epinephrine injection | Experimental | The patients will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice, in 60 seconds, at the end of the procedure Receives: Procedure: Epinephrine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall post-ERCP pancreatitis rate
The rate of post-ERCP pancreatitis
Measured: 30 days
Secondary outcomes (4)
Overall post-ERCP pancreatitis rate in high risk patients
The rate of post-ERCP pancreatitis in high risk patients
Measured: 30 days
Post sphincterotomy bleeding
The rate of post sphincterotomy bleeding
Measured: 30 days
Overall ERCP complications
The rate of overall ERCP complications
Measured: 30 days
Length of hospital stay
Days in hospital after procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jan 2023
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into two groups: rectal indomethacin (Group A) and epinephrine injection (Group B), by computer-generated, numbered, sealed envelopes for treatment assignments. The envelopes will be opened at the end of the procedure, just before the intervention, to enable blinding of the endoscopists. in the randomization process The patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure. The patients in Group B will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salih Tokmak, Principal investigator, Duzce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173179
- Sponsor's protocol ID
- Rectal NSAID vs Epi injection
- Acronym
- PEIR-PEP
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
PubMed 17509029Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
PubMed 25088919Pezzilli R, Romboli E, Campana D, Corinaldesi R. Mechanisms involved in the onset of post-ERCP pancreatitis. JOP. 2002 Nov;3(6):162-8.
PubMed 12432182Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Torun S, Odemis B, Cetin MF, Onmez A, Coskun O. Efficacy of Epinephrine Injection in Preventing Post-ERCP Pancreatitis. Surg Laparosc Endosc Percutan Tech. 2020 Oct 12;31(2):208-214. doi: 10.1097/SLE.0000000000000867.
PubMed 33048897Akshintala VS, Hutfless SM, Colantuoni E, Kim KJ, Khashab MA, Li T, Elmunzer BJ, Puhan MA, Sinha A, Kamal A, Lennon AM, Okolo PI, Palakurthy MK, Kalloo AN, Singh VK. Systematic review with network meta-analysis: pharmacological prophylaxis against post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013 Dec;38(11-12):1325-37. doi: 10.1111/apt.12534. Epub 2013 Oct 20.
PubMed 24138390Aziz M, Ghanim M, Sheikh T, Sharma S, Ghazaleh S, Fatima R, Khan Z, Lee-Smith W, Nawras A. Rectal indomethacin with topical epinephrine versus indomethacin alone for preventing Post-ERCP pancreatitis - A systematic review and meta-analysis. Pancreatology. 2020 Apr;20(3):356-361. doi: 10.1016/j.pan.2020.02.003. Epub 2020 Feb 19.
PubMed 32107191Igawa M, Miyaoka M, Saitoh T. Influence of topical epinephrine application on microcirculatory disturbance in subjects with ulcerative colitis evaluated by laser Doppler flowmetry and transmission electron microscopy. Dig Endosc. 2000;12:126-130
Chung SC, Leung JW, Leung FW. Effect of submucosal epinephrine injection on local gastric blood flow. A study using laser Doppler flowmetry and reflectance spectrophotometry. Dig Dis Sci. 1990 Aug;35(8):1008-11. doi: 10.1007/BF01537250.
PubMed 2384031
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Papillary Undiluted Epinephrine Injection vs Rectal Indomethacin in Preventing Post-ERCP Pancreatitis (PEIR-PEP): A Prospective, Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07173179
- Acronym / sponsor ID
- PEIR-PEP / Rectal NSAID vs Epi injection
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- ERCP, post-ercp acute pancreatitis, epinephrine, indomethacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- 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 pancreatitis (PEP) is the most common and one of the most undesirable major adverse events after endoscopic retrograde cholangiopancreatography (ERCP), causing significant morbidity and even mortality. The incidence rate is almost 15% in high-risk patients and no less than 3% in average-risk patients.
Many factors contribute to PEP, such as patient-related and endoscopist-related factors, but mainly two mechanisms are considered in terms of physiopathology: papillary edema caused by mechanical trauma during cannulation and thermal injury with electrocautery current.
Rectal NSAIDs and pancreatic stent placement are the two proven methods of PEP prophylaxis included in the guideline recommendations, but despite their frequent use, the incidence rates remain unacceptably high. There is a need for additional methods that are easy to implement, preferably low-cost, and safe to reduce the risk of PEP.
Topical epinephrine applied submucosally can meet these goals. Ampullary epinephrine injection is an effective method for post-sphincterotomy bleeding. Still, to our knowledge, no study has examined its efficacy in PEP prophylaxis, except for the retrospective study we reported.
There are conflicting reports on epinephrine spraying onto the papilla for PEP, but these trials are largely heterogeneous, with different dose regimens. It should also be noted that spraying epinephrine onto the papilla has a duration of action of about 1 to 5 minutes, whereas epinephrine injection has a duration of roughly 120 minutes.
Given this information, a large-scale, prospective, double-blind, randomized, controlled trial is designed.
Detailed description
Patients will be randomized into two groups: rectal indomethacin (Group A) and epinephrine injection (Group B), by computer-generated, numbered, sealed envelopes for treatment assignments. The envelopes will be opened before the procedure without the knowledge of the endoscopists to enable blinding in the randomization process
The patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure. The patients in Group B will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice
ERCP procedures will be performed under endoscopist-directed deep sedation. Blood pressure, pulse rate, and electrocardiography will be monitored in all patients during and after the procedure. Demographic data, laboratory values, procedure parameters, and adverse events will be recorded. All patients will be hospitalized for at least 24 hours.
Total procedure time is defined as the interval between esophageal intubation and duodenoscope extubation. Difficult biliary cannulation is defined as ≥5 contacts with the papilla and more than five minutes spent attempting cannulation after the first papillary contact. Cannulation time is defined as the interval between the initial contact of the sphincterotome with the ampullary mound and successful biliary cannulation. Post-ERCP adverse events will be recorded according to the American Society for Gastrointestinal Endoscopy (ASGE) ERCP lexicon. Serum samples will be obtained before the procedure and at four and 24 hours post-ERCP to measure complete blood cell counts, C-reactive protein (CRP), amylase, lipase, bilirubin, and liver enzymes. All patients will be invited for follow-up at 1 week and 1 month after the procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized into two groups: rectal indomethacin (Group A) and epinephrine injection (Group B), by computer-generated, numbered, sealed envelopes for treatment assignments. The envelopes will be opened at the end of the procedure, just before the intervention, to enable blinding of the endoscopists. in the randomization process The patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure. The patients in Group B will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice
| Arm | Type | Receives |
|---|---|---|
| Rectal indomethacin | Active comparator | Drug: IndomethacinThe patients will receive 100mg of rectal indomethacin alone, just before the procedure |
| Peripapillary epinephrine injection | Experimental | Procedure: Epinephrine injectionThe patients will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice, in 60 seconds, at the end of the procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Pregnancy
- Inability to provide written informed consent
- Previous history of ERCP
- Ampulla of Vater cancer
- Surgically altered anatomy
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 |
|---|---|---|
| Epinephrine injectionThe patients will receive a peripapillary injection of 4mg undiluted epinephrine, divided into 1mg in each quadrant of the peripapillary region, 1 to 2 cm from the papillary orifice, at the end of the procedure, in 60 seconds | Procedure or surgery | Peripapillary epinephrine injection |
| IndomethacinThe patients in Group A will receive 100mg of rectal indomethacin alone, just before the procedure | Drug | Rectal indomethacin |
Primary outcome
Overall post-ERCP pancreatitis rate
Time frame: 30 days
The rate of post-ERCP pancreatitis
4 secondary outcomes
Overall post-ERCP pancreatitis rate in high risk patients
Time frame: 30 days
Post sphincterotomy bleeding
Time frame: 30 days
Overall ERCP complications
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
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 17 Jul 2026.
- Background: PubMed 17509029Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
- Background: PubMed 25088919Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
- Background: PubMed 12432182Pezzilli R, Romboli E, Campana D, Corinaldesi R. Mechanisms involved in the onset of post-ERCP pancreatitis. JOP. 2002 Nov;3(6):162-8.
- Background: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Background: PubMed 33048897Torun S, Odemis B, Cetin MF, Onmez A, Coskun O. Efficacy of Epinephrine Injection in Preventing Post-ERCP Pancreatitis. Surg Laparosc Endosc Percutan Tech. 2020 Oct 12;31(2):208-214. doi: 10.1097/SLE.0000000000000867.
- Background: PubMed 24138390Akshintala VS, Hutfless SM, Colantuoni E, Kim KJ, Khashab MA, Li T, Elmunzer BJ, Puhan MA, Sinha A, Kamal A, Lennon AM, Okolo PI, Palakurthy MK, Kalloo AN, Singh VK. Systematic review with network meta-analysis: pharmacological prophylaxis against post-ERCP pancreatitis. Aliment Pharmacol Ther. 2013 Dec;38(11-12):1325-37. doi: 10.1111/apt.12534. Epub 2013 Oct 20.
- Background: PubMed 32107191Aziz M, Ghanim M, Sheikh T, Sharma S, Ghazaleh S, Fatima R, Khan Z, Lee-Smith W, Nawras A. Rectal indomethacin with topical epinephrine versus indomethacin alone for preventing Post-ERCP pancreatitis - A systematic review and meta-analysis. Pancreatology. 2020 Apr;20(3):356-361. doi: 10.1016/j.pan.2020.02.003. Epub 2020 Feb 19.
- BackgroundIgawa M, Miyaoka M, Saitoh T. Influence of topical epinephrine application on microcirculatory disturbance in subjects with ulcerative colitis evaluated by laser Doppler flowmetry and transmission electron microscopy. Dig Endosc. 2000;12:126-130
- Background: PubMed 2384031Chung SC, Leung JW, Leung FW. Effect of submucosal epinephrine injection on local gastric blood flow. A study using laser Doppler flowmetry and reflectance spectrophotometry. Dig Dis Sci. 1990 Aug;35(8):1008-11. doi: 10.1007/BF01537250.
- 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.
Salih Tokmak principal investigator
Duzce 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 injection and Indomethacin in people with Post-ERCP Acute Pancreatitis, run by Duzce University at 1 site in Turkey (Türkiye).
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 0 inclusion and 5 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 17 Jul 2026. 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 Turkey (Türkiye). 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.
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?
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?
Overall post-ERCP pancreatitis rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173179, which also lists 9 linked publications.
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 17 Jul 2026.