Pancreatic DiseasePhase 4NCT05832047
Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP Pancreatitis
A Phase 4 study testing Plasma solution (4-hour aggressive hydration), Lactated Ringer solution (4-hour aggressive hydration) and 8-hour aggressive hydration in people with Pancreatic Disease, run by Do Hyun Park at 3 sites in South Korea.
Trial summary
In the existing Aggressive hydration comparison study related to the prevention of post-ERCP pancreatitis (PEP), research bias may occur due to the lack of blinding between fluids, so in this study, the investigators will conduct a multicenter randomized comparative study in which the comparative fluids are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Disease
- What is being tested?
- Plasma solution (4-hour aggressive hydration), Lactated Ringer solution (4-hour aggressive hydration) and 8-hour aggressive hydration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 844 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 19 Jun 2023to 20 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Among patients with naive major duodenal papilla in patients, we will include those who are at average-to-high risk of PEP (if one or more of the following criteria) after ERCP and agree to enroll in this clinical trial.
- 40 years of age or younger
- (Suspected) Sphincter of oddi dysfunction
- The normal level of serum total bilirubin
- History of recurrent pancreatitis
- Require injection of a contrast agent into the pancreatic duct
Show all 11Show fewer
- Require endoscopic biliary or pancreatic sphincterotomy
- Require precut sphincterotomy
- Require endoscopic papillary balloon dilation
- Planned endoscopic papillectomy
- Diagnosed with periampullary tumor and planned for insertion of a self-expanding metal stent
Who cannot join
- Subjects are excluded if they meet any of the following items.
- Not consented to study participation
- 18 years of age or younger
- Severe comorbidities (e.g., end-stage kidney disease, end-stage chronic obstructive pulmonary disease, hypoglycemic dysregulation, decompensated cirrhosis)
- Sepsis (defined as meeting two or more of the following items):
- Body temperature >38.3ºC or <36ºC
Show all 20Show fewer
- Heart rate >90 beats/min
- Tachypnea (respiratory rate > 20 breaths/min)
- Leukocytosis (WBC>12,000/uL) or leukopenia (WBC<4000/uL)
- Acute pancreatitis
- Chronic pancreatitis
- Heart failure (NYHA class 2 or higher)
- Clinical signs of fluid overload
- Hypernatremia (>150 mEq/L) or hyponatremia (<130 mEq/L)
- History of endoscopic sphincterotomy
- History of endoscopic papillary (balloon) dilation
- Hypercalcemia or alkalemia
- Scheduled for regular endoscopic biliary stent change
- Patients with pancreatic head tumors and a presumed low risk for pancreatitis
- Lack of access to the major duodenal papilla due to surgically altered anatomy
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Asan Medical Center
Seoul
Samsung Seoul Hopital
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis : Multicenter, Double Blind, Randomized Controlled Trial
In the existing Aggressive hydration comparison study related to the prevention of post-ERCP pancreatitis (PEP), research bias may occur due to the lack of blinding between fluids, so in this study, the investigators will conduct a multicenter randomized comparative study in which the comparative fluids are double-blinded to observe differences between fluids in the preventive effect of pancreatitis that occurs after ERCP (endoscopic retrograde cholangiopancreatography).
A total of 844 patients scheduled for ERCP will be enrolled in this clinical trial and randomly assigned to the lactated Ringer's solution or to the Plasma solution in a 1:1 ratio. Eligible patients will receive study drug or control drug for up to 24 hours before and after ERCP implementation.
In previous comparative studies related to PEP prevention, research bias may have been introduced because of insufficient blinding of the treatment strategies, as well as instances where the evaluating investigator did not perform blinding. We are therefore conducting a multicenter, randomized comparative study double-blinded as to the two types of fluid (lactated Ringer's solution or plasma solution), and in which the endoscopists, outcome assessors and patients are blinded to the randomization allocation.
Read the detailed description
Post-ERCP pancreatitis (PEP), which occurs in 2% to 15% of all patients undergoing ERCP and is treated conservatively with fasting and sufficient fluid supply according to the standards of care for general acute pancreatitis, and most patients improve within a few days without major complications. However, high-risk patients are more susceptible to PEP with incidence rates between 15% and 42%, and severe pancreatitis can develop in 11.4% of PEP cases with a 3% mortality rate. Therefore, there are significant unmet needs for PEP patients.
In this trial, all patients will receive aggressive hydration involving fluids that are commercially available and widely administered. The trial aims to minimize potential risks and has established routine safety monitoring to protect the participants.
In real practice, it is crucial to consider not just the type of fluid utilized, but also the most effective fluid volume for preventing PEP, along with the optimal timing for administering the fluid. Given that a significant number of ERCPs are performed in outpatient settings in the USA and other countries, the current protocol allowing outpatients to occupy recovery areas for extended periods, such as 8 hours post-ERCP, seems challenging to implement in real clinical practice. These considerations highlight the necessity for a re-evaluation of existing guidelines. Therefore, the present reassessment aims, not only to optimize efficiency and patient flow in medical settings but also to evaluate the effectiveness of the protocol in preventing PEP considering practical duration of intravenous fluid infusion, such as 4 hours postprocedure.
- Conditions
- Pancreatic Disease
- Being tested
- Plasma solution (4-hour aggressive hydration), Lactated Ringer solution (4-hour aggressive hydration), 8-hour aggressive hydration
- Keywords
- ERCP, Endoscopic retrograde cholangiopancreatography, Pancreatitis
- Medical subject headings
- Pancreatic Diseases, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma solution (4-hour aggressive hydration)Drug
Also called Plasma solution-A Inj.
Aggressive hydration : 10 mL/kg injection within 30~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours.
Lactated Ringer solution (4-hour aggressive hydration)Drug
Also called Hartmann Solution inno.N
Aggressive hydration : 10 mL/kg injection within 30~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours.
8-hour aggressive hydrationDrug
Also called 8-h AH
If patients experienced postprocedural abdominal pain Numerical Rating Scale (NRS score>3) or a worsening of abdominal pain compared with the pain before ERCP, the administration of study fluid continues until 8 hours (3 mL/kg/hr ) regardless of the results of serum amylase/lipase within 4 hours after ERCP because serum amylase/lipase within 4 hours after ERCP may have a result approximately 1-2 hours (5 hours-6 hours after ERCP) after blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Plasma solution | Experimental | Plasma solution (HK inno.N Corp., Seoul, Republic of Korea) is a balanced crystalloid solution that contains the same ingredients as Plasma-Lyte A (Baxter International, Deer field, Ill) .
Preprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour). Receives: Drug: Plasma solution (4-hour aggressive hydration); Drug: 8-hour aggressive hydration |
| Lactated Ringer's solution | Active comparator | Preprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour). Receives: Drug: Lactated Ringer solution (4-hour aggressive hydration); Drug: 8-hour aggressive hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of pancreatitis after ERCP
The new onset or worsening of pain in the upper abdomen, accompanied by an elevation of pancreatic enzymes to at least three times the upper normal level within 24 hours after the procedure, requiring hospitalization for a minimum of two nights.
Measured: the next morning or within 24 hours after ERCP
Secondary outcomes (5)
Occurrence of pancreatitis after ERCP at 4 hours after ERCP
The new onset or worsening of pain in the upper abdomen and the level of pancreatic enzymes is elevated>3 times the upper limit of normal level after 4 hours after ERCP
Measured: 4 hours after ERCP
Number of Participants with Clinical signs of fluid overload
Clinical signs of fluid overload, for example, peripheral edema, pulmonary rales, increased jugular venous pressure, hepatojugular reflux, or both wll be monitored by investigator. If these signs are observed, hemodynamic testing or imaging studies will be done to investigate the evidence of pulmonary oedema, peripheral oedema, cardiac insufficiency and hypernatraemia.
Measured: 4 hours and, and the next morning or within 24 hours after ERCP
Number of Participants with Asymptomatic Hyperamylasemia
Elevated level of serum amylase without upper abdominal pain
Measured: 4 hours and, the next morning or within 24 hours after ERCP
Occurrence or aggravation of upper abdominal pain
Occurrence or aggravation of upper abdominal pain
Measured: 4 hours and, the next morning or within 24 hours after ERCP
Days of ERCP-related hospital stay
Time for upper abdominal pain to disappear after the date of ERCP
Measured: Time for upper abdominal pain to disappear after the date of ERCP - up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start19 Jun 2023
- Primary completion25 Jul 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic DiseaseStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 844 participants (actual)
Sponsor and investigators
- Lead sponsor
- Do Hyun Park
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation
- Responsible party
- Sponsor-investigator, Do Hyun Park, Asan Medical Center
- Investigators
- Do Hyun Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832047
- Sponsor's protocol ID
- DHP_ALPS study
- Status last verified
- Feb 2025
- First submitted
- 3 Apr 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paik WH, Huh G, Choi YH, Choi JH, Cho IR, Lee SH, Ryu JK, Kim HJ, Lee T, Park CH, Lee Y, Cho SH, Seo DW, Lee KH, Lee KT, Lee JK, Jang S, Vargo J, Edmundowicz S, Park JK, Park DH. Acetate- Versus Lactate-Buffered Crystalloids for Prevention of Post-ERCP Pancreatitis in Patients Without Access to Rectal NSAIDs: A Multicentre Double-Blind Randomized Trial. United European Gastroenterol J. 2026 Sep;14(7):e70281. doi: 10.1002/ueg2.70281.
PubMed 42640715Cho IR, Choi JH, Park JK, Huh G, Lee SH, Paik WH, Park DH. Aggressive hydration with lactated Ringer's solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial. BMJ Open. 2024 Jul 1;14(7):e084052. doi: 10.1136/bmjopen-2024-084052.
PubMed 38955368
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aggressive Hydration With Lactated Ringer's Solution Versus Plasma Solution for the Prevention of Post ERCP (Endoscopic Retrograde Cholangiopancreatography) Pancreatitis : Multicenter, Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05832047
- Acronym / sponsor ID
- DHP_ALPS study
- Conditions
- Pancreatic Disease
- Keywords
- ERCP, Endoscopic retrograde cholangiopancreatography, Pancreatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 844 participants (actual)
- Lead sponsor
- Do Hyun ParkUniversity, hospital or other
- Collaborators
- HK inno.N Corporation
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 27 Apr 2023 (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.
In the existing Aggressive hydration comparison study related to the prevention of post-ERCP pancreatitis (PEP), research bias may occur due to the lack of blinding between fluids, so in this study, the investigators will conduct a multicenter randomized comparative study in which the comparative fluids are double-blinded to observe differences between fluids in the preventive effect of pancreatitis that occurs after ERCP (endoscopic retrograde cholangiopancreatography).
A total of 844 patients scheduled for ERCP will be enrolled in this clinical trial and randomly assigned to the lactated Ringer's solution or to the Plasma solution in a 1:1 ratio. Eligible patients will receive study drug or control drug for up to 24 hours before and after ERCP implementation.
In previous comparative studies related to PEP prevention, research bias may have been introduced because of insufficient blinding of the treatment strategies, as well as instances where the evaluating investigator did not perform blinding. We are therefore conducting a multicenter, randomized comparative study double-blinded as to the two types of fluid (lactated Ringer's solution or plasma solution), and in which the endoscopists, outcome assessors and patients are blinded to the randomization allocation.
Detailed description
Post-ERCP pancreatitis (PEP), which occurs in 2% to 15% of all patients undergoing ERCP and is treated conservatively with fasting and sufficient fluid supply according to the standards of care for general acute pancreatitis, and most patients improve within a few days without major complications. However, high-risk patients are more susceptible to PEP with incidence rates between 15% and 42%, and severe pancreatitis can develop in 11.4% of PEP cases with a 3% mortality rate. Therefore, there are significant unmet needs for PEP patients.
In this trial, all patients will receive aggressive hydration involving fluids that are commercially available and widely administered. The trial aims to minimize potential risks and has established routine safety monitoring to protect the participants.
In real practice, it is crucial to consider not just the type of fluid utilized, but also the most effective fluid volume for preventing PEP, along with the optimal timing for administering the fluid. Given that a significant number of ERCPs are performed in outpatient settings in the USA and other countries, the current protocol allowing outpatients to occupy recovery areas for extended periods, such as 8 hours post-ERCP, seems challenging to implement in real clinical practice. These considerations highlight the necessity for a re-evaluation of existing guidelines. Therefore, the present reassessment aims, not only to optimize efficiency and patient flow in medical settings but also to evaluate the effectiveness of the protocol in preventing PEP considering practical duration of intravenous fluid infusion, such as 4 hours postprocedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma solution | Experimental | Drug: Plasma solution (4-hour aggressive hydration), Drug: 8-hour aggressive hydrationPlasma solution (HK inno.N Corp., Seoul, Republic of Korea) is a balanced crystalloid solution that contains the same ingredients as Plasma-Lyte A (Baxter International, Deer field, Ill) . Preprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour). |
| Lactated Ringer's solution | Active comparator | Drug: Lactated Ringer solution (4-hour aggressive hydration), Drug: 8-hour aggressive hydrationPreprocedure hydration begins 30-90 min before ERCP with an infusion rate of 10 mL/kg. All the ERCP procedures are performed under sedation with balanced propofol sedation (incremental dose of propofol in combination with fixed doses of fentanyl and midazolam), without general anaesthesia. The infusion rate during ERCP and 30-60 min after ERCP is 3 mL/kg/hour and 10 mL/kg, respectively (in the case of a 10 mL/kg injection after the procedure, the injection should be stopped at the point where it is necessary to move from the endoscopy room to the ward after the procedure, and the injection rate can be changed to 3 mL/kg/hour). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Among patients with naive major duodenal papilla in patients, we will include those who are at average-to-high risk of PEP (if one or more of the following criteria) after ERCP and agree to enroll in this clinical trial.
- 40 years of age or younger
- (Suspected) Sphincter of oddi dysfunction
- The normal level of serum total bilirubin
- History of recurrent pancreatitis
Key exclusion criteria (20 listed)
- Subjects are excluded if they meet any of the following items.
- Not consented to study participation
- 18 years of age or younger
- Severe comorbidities (e.g., end-stage kidney disease, end-stage chronic obstructive pulmonary disease, hypoglycemic dysregulation, decompensated cirrhosis)
- Sepsis (defined as meeting two or more of the following items):
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 |
|---|---|---|
| Plasma solution (4-hour aggressive hydration)Also: Plasma solution-A Inj.Aggressive hydration : 10 mL/kg injection within 30~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours. | Drug | Plasma solution |
| Lactated Ringer solution (4-hour aggressive hydration)Also: Hartmann Solution inno.NAggressive hydration : 10 mL/kg injection within 30~90min before procedure, 3 mL/kg/hr fluid injection during procedure, 10 mL/kg injection within 30~60min after procedure, fluid, injection at 3 mL/kg/hr for 4 hours. | Drug | Lactated Ringer's solution |
| 8-hour aggressive hydrationAlso: 8-h AHIf patients experienced postprocedural abdominal pain Numerical Rating Scale (NRS score>3) or a worsening of abdominal pain compared with the pain before ERCP, the administration of study fluid continues until 8 hours (3 mL/kg/hr ) regardless of the results of serum amylase/lipase within 4 hours after ERCP because serum amylase/lipase within 4 hours after ERCP may have a result approximately 1-2 hours (5 hours-6 hours after ERCP) after blood sampling | Drug | Lactated Ringer's solution, Plasma solution |
Primary outcome
Occurrence of pancreatitis after ERCP
Time frame: the next morning or within 24 hours after ERCP
The new onset or worsening of pain in the upper abdomen, accompanied by an elevation of pancreatic enzymes to at least three times the upper normal level within 24 hours after the procedure, requiring hospitalization for a minimum of two nights.
5 secondary outcomes
Occurrence of pancreatitis after ERCP at 4 hours after ERCP
Time frame: 4 hours after ERCP
Number of Participants with Clinical signs of fluid overload
Time frame: 4 hours and, and the next morning or within 24 hours after ERCP
Number of Participants with Asymptomatic Hyperamylasemia
Time frame: 4 hours and, the next morning or within 24 hours after ERCP
Occurrence or aggravation of upper abdominal pain
Time frame: 4 hours and, the next morning or within 24 hours after ERCP
Days of ERCP-related hospital stay
Time frame: Time for upper abdominal pain to disappear after the date of ERCP - up to 20 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 6 Feb 2025.
- Derived from this study: PubMed 42640715Paik WH, Huh G, Choi YH, Choi JH, Cho IR, Lee SH, Ryu JK, Kim HJ, Lee T, Park CH, Lee Y, Cho SH, Seo DW, Lee KH, Lee KT, Lee JK, Jang S, Vargo J, Edmundowicz S, Park JK, Park DH. Acetate- Versus Lactate-Buffered Crystalloids for Prevention of Post-ERCP Pancreatitis in Patients Without Access to Rectal NSAIDs: A Multicentre Double-Blind Randomized Trial. United European Gastroenterol J. 2026 Sep;14(7):e70281. doi: 10.1002/ueg2.70281.
- Derived from this study: PubMed 38955368Cho IR, Choi JH, Park JK, Huh G, Lee SH, Paik WH, Park DH. Aggressive hydration with lactated Ringer's solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial. BMJ Open. 2024 Jul 1;14(7):e084052. doi: 10.1136/bmjopen-2024-084052.
- 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.
Do Hyun Park, MD, PhD principal investigator
Asan Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasma solution (4-hour aggressive hydration), Lactated Ringer solution (4-hour aggressive hydration) and 8-hour aggressive hydration in people with Pancreatic Disease, run by Do Hyun Park at 3 sites in South Korea.
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 11 inclusion and 20 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Occurrence of pancreatitis after ERCP (time frame: the next morning or within 24 hours after ERCP). 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 NCT05832047, which also lists 2 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 6 Feb 2025.