Post-ERCP Acute PancreatitisNCT02308891
A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis
A study testing lactated Ringer's solution (vigorous hydration arm), lactated Ringer's solution (standard hydration arm) and endoscopic retrograde cholangiopancreatography (ERCP) in people with Post-ERCP Acute Pancreatitis, run by Dankook University at 3 sites in South Korea.
Trial summary
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- What is being tested?
- lactated Ringer's solution (vigorous hydration arm), lactated Ringer's solution (standard hydration arm) and endoscopic retrograde cholangiopancreatography (ERCP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Nov 2014to Jun 2016
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited
Who cannot join
- Patients will be excluded if they have acute pancreatitis during the 2 weeks before ERCP, a history of chronic pancreatitis, previous sphincterotomy, or if they refuse to participate the study protocol. Patients will be also excluded if they undergo ERCP, for procedures such as stone removal following previous sphincterotomy, change or removal of previous biliary stents, or surveillance biopsy after endoscopic papillectomy without pancreatography, which are considered to carry minimal risks of post-ERCP pancreatitis. Patients with high risk of fluid overload (heart failure, more than NYHA II; renal insufficiency, creatinine clearance <40ml/min; liver cirrhosis; or hypoxemia, SaO2 <90%; signs of pulmonary edema) are excluded.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Dankook University College of Medicine
Cheonan, Chungcheongnam-do, 330-715
Wonkwang University
Iksan, Jeollabukdo
University of Ulsan, Ulsa University Hospital
Ulsan
About this study
Official title: Multicenter Prospective Randomized Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis.
Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited.
Read more
Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers.
Treatment arm (vigorous hydration arm);
- Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP
- Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours.
- At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1hour Standard arm (standard hydration arm);
- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP.
The primary endpoint was development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).
The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.
Read the detailed description
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis.
Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers.
Treatment arm (vigorous hydration arm);
- Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP
- Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours.
- At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1 hour
Standard arm (standard hydration arm);
- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP.
The primary endpoint is development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).
The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.
Serum amylase levels are measured at baseline, and at 8 hours and 18-24 hours, 48 hours after the procedure.
Investigators recorded the details of the maneuvers performed, including:
- the total time of the procedure,
- the number of attempts at cannulation,
- the number of pancreatic duct cannulation,
- the final diagnosis by ERCP,
- whether a sphincterotomy, a needle-knife papillotomy, or stent placement
- endoscopic papillary balloon dilation,
- common bile duct (C) tissue sampling (biopsy, brush, cytology),
- common bile duct-intraductal ultrasonography (C-IDUS),
- Serum amylase is determined 8, 18~24, and 48 hours after ERCP.
- If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
- Acute pancreatitis is defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
- Statistical analysis:
- Randomization was done by the GI nurse, concealed envelop
- Data were summarized by descriptive statistics.
- The Chi square was used to compare categorical patient data.
- The Student's t test was used to compare continuous variables.
- Two-tailed P < 0.05 was considered to indicate significance.
- Conditions
- Post-ERCP Acute Pancreatitis
- Being tested
- lactated Ringer's solution (vigorous hydration arm), lactated Ringer's solution (standard hydration arm), endoscopic retrograde cholangiopancreatography (ERCP)
- Keywords
- pancreatitis, ERCP
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactated Ringer's solution (vigorous hydration arm)Drug
- Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP
- Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours.
- At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour
lactated Ringer's solution (standard hydration arm)Drug
- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP.
endoscopic retrograde cholangiopancreatography (ERCP)Device
endoscopic retrograde cholangiopancreatography
| Study group | Role | What they receive |
|---|---|---|
| vigorous hydration arm | Experimental | Patients will be randomly allocated to vigorous hydration arm. Patients in the vigorous hydration arm will receive fluids via infusion by the following protocol.
* Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP
* Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours.
* At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour Receives: Drug: lactated Ringer's solution (vigorous hydration arm); Device: endoscopic retrograde cholangiopancreatography (ERCP) |
| standard hydration arm | Active comparator | Patients will be randomly allocated to standard hydration arm. Patients in the standard hydration arm will receive fluids via infusion by the following protocol.
- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP. Receives: Drug: lactated Ringer's solution (standard hydration arm); Device: endoscopic retrograde cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of post-ERCP pancreatitis
define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).
Measured: 48 hours
Secondary outcomes (3)
development of hyperamylasemia
hyperamylasemia (three times the upper limit of normal).
Measured: 48 hours
severity of pancreatitis
pancreatitis criteria
Measured: 3 months
any signs of fluid overload
pulmonary or peripheral edema
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dankook University
- Sponsor type
- University, hospital or other
- Collaborators
- Wonkwang University, University of Ulsan
- Responsible party
- Principal investigator, Jun Ho Choi, Dankook University
- Investigators
- Jun Ho Choi, MD, Principal investigator, Dankook University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308891
- Sponsor's protocol ID
- 2014-09-011
- Status last verified
- Aug 2016
- First submitted
- 26 Nov 2014
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi JH, Kim HJ, Lee BU, Kim TH, Song IH. Vigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients. Clin Gastroenterol Hepatol. 2017 Jan;15(1):86-92.e1. doi: 10.1016/j.cgh.2016.06.007. Epub 2016 Jun 14.
PubMed 27311618
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Randomized Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT02308891
- Acronym / sponsor ID
- 2014-09-011
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- pancreatitis, ERCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Dankook UniversityUniversity, hospital or other
- Collaborators
- Wonkwang University, University of Ulsan
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Dec 2014 (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.
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis.
Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited.
Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers.
Treatment arm (vigorous hydration arm);
- Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP
- Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours.
- At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1hour Standard arm (standard hydration arm);
- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP.
The primary endpoint was development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).
The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.
Detailed description
Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis.
Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers.
Treatment arm (vigorous hydration arm);
- Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP
- Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours.
- At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1 hour
Standard arm (standard hydration arm);
- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP.
The primary endpoint is development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).
The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.
Serum amylase levels are measured at baseline, and at 8 hours and 18-24 hours, 48 hours after the procedure.
Investigators recorded the details of the maneuvers performed, including:
- the total time of the procedure,
- the number of attempts at cannulation,
- the number of pancreatic duct cannulation,
- the final diagnosis by ERCP,
- whether a sphincterotomy, a needle-knife papillotomy, or stent placement
- endoscopic papillary balloon dilation,
- common bile duct (C) tissue sampling (biopsy, brush, cytology),
- common bile duct-intraductal ultrasonography (C-IDUS),
- Serum amylase is determined 8, 18~24, and 48 hours after ERCP.
- If the 12-hours serum amylase level was > 3 times the upper normal limit and the patient exhibited pain or nausea and vomiting, then the patient had pancreatitis.
- Acute pancreatitis is defined as serum amylase > 3 times the upper limit of normal and associated with epigastric pain, back pain, and epigastric tenderness.
- Statistical analysis:
- Randomization was done by the GI nurse, concealed envelop
- Data were summarized by descriptive statistics.
- The Chi square was used to compare categorical patient data.
- The Student's t test was used to compare continuous variables.
- Two-tailed P < 0.05 was considered to indicate significance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vigorous hydration arm | Experimental | Drug: lactated Ringer's solution (vigorous hydration arm), Device: endoscopic retrograde cholangiopancreatography (ERCP)Patients will be randomly allocated to vigorous hydration arm. Patients in the vigorous hydration arm will receive fluids via infusion by the following protocol. * Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP * Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours. * At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour |
| standard hydration arm | Active comparator | Drug: lactated Ringer's solution (standard hydration arm), Device: endoscopic retrograde cholangiopancreatography (ERCP)Patients will be randomly allocated to standard hydration arm. Patients in the standard hydration arm will receive fluids via infusion by the following protocol. - Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited
Key exclusion criteria (1 listed)
- Patients will be excluded if they have acute pancreatitis during the 2 weeks before ERCP, a history of chronic pancreatitis, previous sphincterotomy, or if they refuse to participate the study protocol. Patients will be also excluded if they undergo ERCP, for procedures such as stone removal following previous sphincterotomy, change or removal of previous biliary stents, or surveillance biopsy after endoscopic papillectomy without pancreatography, which are considered to carry minimal risks of post-ERCP pancreatitis. Patients with high risk of fluid overload (heart failure, more than NYHA II; renal insufficiency, creatinine clearance <40ml/min; liver cirrhosis; or hypoxemia, SaO2 <90%; signs of pulmonary edema) are excluded.
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 |
|---|---|---|
| lactated Ringer's solution (vigorous hydration arm)* Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP * Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours. * At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour | Drug | vigorous hydration arm |
| lactated Ringer's solution (standard hydration arm)- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP. | Drug | standard hydration arm |
| endoscopic retrograde cholangiopancreatography (ERCP)endoscopic retrograde cholangiopancreatography | Device | standard hydration arm, vigorous hydration arm |
Primary outcome
development of post-ERCP pancreatitis
Time frame: 48 hours
define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).
3 secondary outcomes
development of hyperamylasemia
Time frame: 48 hours
severity of pancreatitis
Time frame: 3 months
any signs of fluid overload
Time frame: 48 hours
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 5 Aug 2016.
- Derived from this study: PubMed 27311618Choi JH, Kim HJ, Lee BU, Kim TH, Song IH. Vigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients. Clin Gastroenterol Hepatol. 2017 Jan;15(1):86-92.e1. doi: 10.1016/j.cgh.2016.06.007. Epub 2016 Jun 14.
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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.
Jun Ho Choi, MD principal investigator
Dankook University College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lactated Ringer's solution (vigorous hydration arm), lactated Ringer's solution (standard hydration arm) and endoscopic retrograde cholangiopancreatography (ERCP) in people with Post-ERCP Acute Pancreatitis, run by Dankook University 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 1 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 5 Aug 2016. 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.
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?
development of post-ERCP pancreatitis (time frame: 48 hours). 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 NCT02308891, which also lists 1 linked publication.
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 5 Aug 2016.