Endoscopic Retrograde Cholangiopancreatography (ERCP)NCT07417020
Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis
A study testing Aggressive intravenous hydration with lactated Ringer's solution and Standard intravenous hydration with lactated Ringer's solution in people with Endoscopic Retrograde Cholangiopancreatography (ERCP) and Choledocholithiasis, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
Endoscopic Retrograde Cholangiopancreatography, also called ERCP, is a procedure used to diagnose and treat disorders of the bile ducts and pancreas. A common and potentially serious complication after ERCP is post ERCP pancreatitis, which is inflammation of the pancreas that can cause abdominal pain, raised… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Choledocholithiasis, Bile Duct Disorder
- What is being tested?
- Aggressive intravenous hydration with lactated Ringer's solution and Standard intravenous hydration with lactated Ringer's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Mar 2024to 1 Mar 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 to 70 years.
- Both males and females.
- Patients undergoing their first Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis, bile duct leak, or biliary obstruction.
Who cannot join
- Patients who have previously undergone an ERCP, endoscopic sphincterectomy, or endoscopic papillary balloon dilatation.
- Individuals with a known history of chronic pancreatitis, ongoing acute pancreatitis, or patients with gallstone pancreatitis or active cholangitis.
- Patients with coagulopathy or those on anticoagulation therapy.
- Pregnant or lactating women.
- Substance abuse: Individuals with a history of alcohol or other substance abuse disorders.
- Patients having hypernatremia or hyponatremia (Na <130 or Na >150 mEq/L) or Hyperkalemia (>5.1 mEq/dL).
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- Specific organ dysfunctions:
- Patients with organ dysfunctions including cardiac insufficiency (New York Heart Association Class II or above), respiratory insufficiency (oxygen saturation <90%), renal insufficiency (creatinine clearance <40 mL/min), or liver dysfunction.
- Clinical signs of fluid overload, specifically peripheral or pulmonary edema, and ongoing hypotension, including those with sepsis.
- Patients undergoing sphincterotomy as it reduces the risk of pancreatitis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis: A Randomized Controlled Trial
Endoscopic Retrograde Cholangiopancreatography, also called ERCP, is a procedure used to diagnose and treat disorders of the bile ducts and pancreas. A common and potentially serious complication after ERCP is post ERCP pancreatitis, which is inflammation of the pancreas that can cause abdominal pain, raised pancreatic enzymes, prolonged hospital stay, and increased health care costs. Several preventive approaches have been evaluated, but an optimal, simple strategy that can be applied consistently in routine practice remains uncertain. This randomized controlled trial was evaluated whether giving a higher amount of intravenous lactated Ringer's solution around the time of ERCP reduces the risk of post ERCP pancreatitis compared with standard hydration. Adults aged 18 to 70 years undergoing their first ERCP for choledocholithiasis, bile duct leak, or biliary obstruction were randomly allocated to standard hydration or aggressive hydration. Standard hydration consists of lactated Ringer's solution at 1.5 mL/kg/hour during ERCP and for 8 hours after the procedure. Aggressive hydration consisted of lactated Ringer's solution at 3 mL/kg/hour during ERCP, followed immediately by a 20 mL/kg bolus and then 3 mL/kg/hour for 8 hours, with reduction to 1.5 mL/kg/hour if pain is absent after 8 hours. The primary hypothesis was that aggressive hydration is more effective than standard hydration in preventing post ERCP pancreatitis. Post procedure serum amylase was measured at 12 and 24 hours, and pain was assessed using a visual analog scale at 4, 12, and 24 hours. The main outcome is post ERCP pancreatitis, defined by new or worsening abdominal pain with enzyme elevation more than three times the upper limit of normal at 24 hours and a hospital stay of at least 2 days. Secondary outcomes include isolated hyperamylasemia, post procedure pain, and length of hospital stay. The study was conducted over 12 months at the Department of Gastroenterology, Lahore General Hospital, Lahore, with a total sample size of 126 participants.
- Conditions
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Choledocholithiasis, Bile Duct Disorder, Biliary Obstruction
- Being tested
- Aggressive intravenous hydration with lactated Ringer's solution, Standard intravenous hydration with lactated Ringer's solution
- Keywords
- Endoscopic retrograde cholangiopancreatography, Post endoscopic retrograde cholangiopancreatography pancreatitis, Acute pancreatitis, Fluid therapy, Lactated Ringer's solution, Aggressive intravenous hydration
- Medical subject headings
- Choledocholithiasis, Bile Duct Diseases, Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aggressive intravenous hydration with lactated Ringer's solutionOther
Also called Lactated Ringer's solution (aggressive protocol)
Lactated Ringer's solution at 3 mL/kg/hour during endoscopic retrograde cholangiopancreatography. Immediately after the procedure, 20 mL/kg bolus of lactated Ringer's solution. Then 3 mL/kg/hour for 8 hours. If no pain after 8 hours, rate reduced to 1.5 mL/kg/hour. Hydration discontinued once the patient can comfortably tolerate a regular diet
Standard intravenous hydration with lactated Ringer's solutionOther
Also called Lactated Ringer's solution (standard protocol)
Lactated Ringer's solution at 1.5 mL/kg/hour during endoscopic retrograde cholangiopancreatography. Continued at 1.5 mL/kg/hour for 8 hours after the procedure. If post endoscopic retrograde cholangiopancreatography pancreatitis develops, a 20 mL/kg bolus may be administered, followed by 3 mL/kg/hour, as per management protocol
| Study group | Role | What they receive |
|---|---|---|
| Group Aggressive Hydration | Experimental | Received aggressive intravenous hydration with lactated Ringer's solution during endoscopic retrograde cholangiopancreatography and for the subsequent 8 hours post procedure, according to the study protocol. Receives: Other: Aggressive intravenous hydration with lactated Ringer's solution |
| Group Standard Hydration | Active comparator | Received standard intravenous hydration with lactated Ringer's solution during endoscopic retrograde cholangiopancreatography and for the subsequent 8 hours post procedure, according to standard care protocol. Receives: Other: Standard intravenous hydration with lactated Ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post endoscopic retrograde cholangiopancreatography pancreatitis
Post endoscopic retrograde cholangiopancreatography pancreatitis was diagnosed when new or worsening abdominal pain occurs after the procedure, with pancreatic enzyme elevation more than three times the upper limit of normal at 24 hours, and the clinical course requires hospital admission for at least 2 days.
Measured: 24 hours after endoscopic retrograde cholangiopancreatography, with confirmation based on a hospital stay of at least 2 days
Secondary outcomes (3)
Frequency of isolated hyperamylasemia
Isolated hyperamylasemia was defined as serum amylase elevation more than three times the upper limit of normal during the first 24 hours after the procedure, without meeting criteria for post endoscopic retrograde cholangiopancreatography pancreatitis.
Measured: 12 hours and 24 hours after endoscopic retrograde cholangiopancreatography
Post procedure abdominal pain severity assessed by Visual Analog Scale
Abdominal pain was assessed using a 0 to 10 Visual Analog Scale. Pancreatic pain will be defined as development of pain, or an increase in pain, of at least 3 points compared with pre procedure pain score, persisting during follow up.
Measured: 4 hours, 12 hours, and 24 hours after endoscopic retrograde cholangiopancreatography
Length of hospital stay
Length of hospital stay was measured as the number of days from the day of endoscopic retrograde cholangiopancreatography to the day of discharge within 30 days.
Measured: From day of endoscopic retrograde cholangiopancreatography until hospital discharge within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Retrograde Cholangiopancreatography (ERCP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Ali Hassan, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417020
- Sponsor's protocol ID
- LahoreGeneralH14
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Prophylactic Aggressive Hydration to Prevent Post-ERCP Pancreatitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07417020
- Acronym / sponsor ID
- LahoreGeneralH14
- Conditions
- Endoscopic Retrograde Cholangiopancreatography (ERCP), Choledocholithiasis, Bile Duct Disorder, Biliary Obstruction
- Keywords
- Endoscopic retrograde cholangiopancreatography, Post endoscopic retrograde cholangiopancreatography pancreatitis, Acute pancreatitis, Fluid therapy, Lactated Ringer's solution, Aggressive intravenous hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 2 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 18 Feb 2026 (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.
Endoscopic Retrograde Cholangiopancreatography, also called ERCP, is a procedure used to diagnose and treat disorders of the bile ducts and pancreas. A common and potentially serious complication after ERCP is post ERCP pancreatitis, which is inflammation of the pancreas that can cause abdominal pain, raised pancreatic enzymes, prolonged hospital stay, and increased health care costs. Several preventive approaches have been evaluated, but an optimal, simple strategy that can be applied consistently in routine practice remains uncertain. This randomized controlled trial was evaluated whether giving a higher amount of intravenous lactated Ringer's solution around the time of ERCP reduces the risk of post ERCP pancreatitis compared with standard hydration. Adults aged 18 to 70 years undergoing their first ERCP for choledocholithiasis, bile duct leak, or biliary obstruction were randomly allocated to standard hydration or aggressive hydration. Standard hydration consists of lactated Ringer's solution at 1.5 mL/kg/hour during ERCP and for 8 hours after the procedure. Aggressive hydration consisted of lactated Ringer's solution at 3 mL/kg/hour during ERCP, followed immediately by a 20 mL/kg bolus and then 3 mL/kg/hour for 8 hours, with reduction to 1.5 mL/kg/hour if pain is absent after 8 hours. The primary hypothesis was that aggressive hydration is more effective than standard hydration in preventing post ERCP pancreatitis. Post procedure serum amylase was measured at 12 and 24 hours, and pain was assessed using a visual analog scale at 4, 12, and 24 hours. The main outcome is post ERCP pancreatitis, defined by new or worsening abdominal pain with enzyme elevation more than three times the upper limit of normal at 24 hours and a hospital stay of at least 2 days. Secondary outcomes include isolated hyperamylasemia, post procedure pain, and length of hospital stay. The study was conducted over 12 months at the Department of Gastroenterology, Lahore General Hospital, Lahore, with a total sample size of 126 participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Aggressive Hydration | Experimental | Other: Aggressive intravenous hydration with lactated Ringer's solutionReceived aggressive intravenous hydration with lactated Ringer's solution during endoscopic retrograde cholangiopancreatography and for the subsequent 8 hours post procedure, according to the study protocol. |
| Group Standard Hydration | Active comparator | Other: Standard intravenous hydration with lactated Ringer's solutionReceived standard intravenous hydration with lactated Ringer's solution during endoscopic retrograde cholangiopancreatography and for the subsequent 8 hours post procedure, according to standard care protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 to 70 years.
- Both males and females.
- Patients undergoing their first Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis, bile duct leak, or biliary obstruction.
Key exclusion criteria (10 listed)
- Patients who have previously undergone an ERCP, endoscopic sphincterectomy, or endoscopic papillary balloon dilatation.
- Individuals with a known history of chronic pancreatitis, ongoing acute pancreatitis, or patients with gallstone pancreatitis or active cholangitis.
- Patients with coagulopathy or those on anticoagulation therapy.
- Pregnant or lactating women.
- Substance abuse: Individuals with a history of alcohol or other substance abuse disorders.
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 |
|---|---|---|
| Aggressive intravenous hydration with lactated Ringer's solutionAlso: Lactated Ringer's solution (aggressive protocol)Lactated Ringer's solution at 3 mL/kg/hour during endoscopic retrograde cholangiopancreatography. Immediately after the procedure, 20 mL/kg bolus of lactated Ringer's solution. Then 3 mL/kg/hour for 8 hours. If no pain after 8 hours, rate reduced to 1.5 mL/kg/hour. Hydration discontinued once the patient can comfortably tolerate a regular diet | Other | Group Aggressive Hydration |
| Standard intravenous hydration with lactated Ringer's solutionAlso: Lactated Ringer's solution (standard protocol)Lactated Ringer's solution at 1.5 mL/kg/hour during endoscopic retrograde cholangiopancreatography. Continued at 1.5 mL/kg/hour for 8 hours after the procedure. If post endoscopic retrograde cholangiopancreatography pancreatitis develops, a 20 mL/kg bolus may be administered, followed by 3 mL/kg/hour, as per management protocol | Other | Group Standard Hydration |
Primary outcome
Incidence of post endoscopic retrograde cholangiopancreatography pancreatitis
Time frame: 24 hours after endoscopic retrograde cholangiopancreatography, with confirmation based on a hospital stay of at least 2 days
Post endoscopic retrograde cholangiopancreatography pancreatitis was diagnosed when new or worsening abdominal pain occurs after the procedure, with pancreatic enzyme elevation more than three times the upper limit of normal at 24 hours, and the clinical course requires hospital admission for at least 2 days.
3 secondary outcomes
Frequency of isolated hyperamylasemia
Time frame: 12 hours and 24 hours after endoscopic retrograde cholangiopancreatography
Post procedure abdominal pain severity assessed by Visual Analog Scale
Time frame: 4 hours, 12 hours, and 24 hours after endoscopic retrograde cholangiopancreatography
Length of hospital stay
Time frame: From day of endoscopic retrograde cholangiopancreatography until hospital discharge within 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 18 Feb 2026.
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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.
Ali Hassan principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aggressive intravenous hydration with lactated Ringer's solution and Standard intravenous hydration with lactated Ringer's solution in people with Endoscopic Retrograde Cholangiopancreatography (ERCP) and Choledocholithiasis, run by Lahore General Hospital at 1 site in Pakistan.
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 10 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 18 Feb 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 Pakistan. 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?
Incidence of post endoscopic retrograde cholangiopancreatography pancreatitis (time frame: 24 hours after endoscopic retrograde cholangiopancreatography, with confirmation based on a hospital stay of at least 2 days). 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 18 Feb 2026.