Post ERCP PancreatitisERCPNCT07677397
Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis
A study testing Ice cold water flushing post ERCP in people with Post ERCP Pancreatitis, run by Oman Ministry of Health.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential diagnostic and therapeutic tool used to manage diseases of the pancreatic and biliary systems. During the procedure, an upper endoscope is used to reach the major duodenal papilla, and a contrast material is injected into the ducts for radiologic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post ERCP Pancreatitis
- What is being tested?
- Ice cold water flushing post ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 28 Jun 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All adults (agesld 18 years old) scheduled for an endoscopic sphincterotomy at the participating hospitals.
Who cannot join
- Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent.
About this study
Official title: A Multicenter Randomized Controlled Trial of Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential diagnostic and therapeutic tool used to manage diseases of the pancreatic and biliary systems. During the procedure, an upper endoscope is used to reach the major duodenal papilla, and a contrast material is injected into the ducts for radiologic imaging. In an endoscopic sphincterotomy, a specialized knife cuts the biliary sphincter to treat papilla conditions or facilitate therapeutic interventions.
The most common complication following an ERCP is pancreatitis, carrying an incidence rate of 3.5% to 9.7%. Standard preventive strategies currently include careful patient selection, rectal administration of NSAIDs (like indomethacin or diclofenac), aggressive intravenous hydration, and pancreatic stent placement.
The Innovation: Flushing the ampulla with ice-cold water after a sphincterotomy is a safe,easy, and cost-effective evolving intervention. While initial data demonstrates its safety,there is a clear deficiency in multicenter randomized trials assessing its overall clinical effectiveness, and no such studies have been conducted in the Gulf region. The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis.
Read the detailed description
This is a multicenter, randomized, controlled trial representing the population of Oman. A total of 210 adult patients (aged 18 and older) undergoing endoscopic sphincterotomy will be randomly assigned in a 1:1 ratio (105 patients per group) using stratified block randomization.The active group will receive a 250 mL ice-cold water flush of theampulla following sphincterotomy, while the control group will receive standard care without the flush.All adults (aged 18 years old and above) scheduled for an endoscopic sphincterotomy at the participating hospitals will be included. Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent will be excluded . Data will be prospectively retrieved from electronic hospital information systems (Trackcare at SQUH; AL-Shifa-3 at RH and NH) via printed data sheets. The results of this pioneering regional study are expected to provoke a shift in standard ERCP practices, successfully lowering patient complication rates and shortening hospital stays. Furthermore, it will build the first dedicated database from the Gulf region to drive future meta-analyses and advance advanced gastrointestinal research.
- Conditions
- Post ERCP Pancreatitis
- Being tested
- Ice cold water flushing post ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice cold water flushing post ERCPProcedure or surgery
250 mL ice-cold water flush of the ampulla following sphincterotomy,
| Study group | Role | What they receive |
|---|---|---|
| Standard ERCP , no intervention | No intervention | Not described |
| Post ERCP flushing | Experimental | Not described Receives: Procedure: Ice cold water flushing post ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether ice cold water flushing of the ampulla after ERCP reduces incidence of post ERCP pancreatitis compared to no flushing.
The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis.
Specific Objectives:
- Procedure Efficiency: Compare the time required, success rate of cannulation, and rate of pancreatic stenting between patients who receive the ice-cold water flush and those who do not.
- Complication Rates: Contrast post-sphincterotomy complications and the specific severity of post-procedure pancreatitis between the two groups.
- Recovery and Burden: Compare the total length of hospital stay and the frequency of hospital revisits within 4 weeks post-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 posted30 Jun 2026
- Study start28 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post ERCP 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677397
- Sponsor's protocol ID
- MoH/CSR/25/31333
- Acronym
- ERCP
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial of Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis
- ClinicalTrials.gov ID
- NCT07677397
- Acronym / sponsor ID
- ERCP / MoH/CSR/25/31333
- Conditions
- Post ERCP Pancreatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Oman Ministry of HealthOther government
- Study start
- 28 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 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 (ERCP) is an essential diagnostic and therapeutic tool used to manage diseases of the pancreatic and biliary systems. During the procedure, an upper endoscope is used to reach the major duodenal papilla, and a contrast material is injected into the ducts for radiologic imaging. In an endoscopic sphincterotomy, a specialized knife cuts the biliary sphincter to treat papilla conditions or facilitate therapeutic interventions.
The most common complication following an ERCP is pancreatitis, carrying an incidence rate of 3.5% to 9.7%. Standard preventive strategies currently include careful patient selection, rectal administration of NSAIDs (like indomethacin or diclofenac), aggressive intravenous hydration, and pancreatic stent placement.
The Innovation: Flushing the ampulla with ice-cold water after a sphincterotomy is a safe,easy, and cost-effective evolving intervention. While initial data demonstrates its safety,there is a clear deficiency in multicenter randomized trials assessing its overall clinical effectiveness, and no such studies have been conducted in the Gulf region. The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis.
Detailed description
This is a multicenter, randomized, controlled trial representing the population of Oman. A total of 210 adult patients (aged 18 and older) undergoing endoscopic sphincterotomy will be randomly assigned in a 1:1 ratio (105 patients per group) using stratified block randomization.The active group will receive a 250 mL ice-cold water flush of theampulla following sphincterotomy, while the control group will receive standard care without the flush.All adults (aged 18 years old and above) scheduled for an endoscopic sphincterotomy at the participating hospitals will be included. Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent will be excluded . Data will be prospectively retrieved from electronic hospital information systems (Trackcare at SQUH; AL-Shifa-3 at RH and NH) via printed data sheets. The results of this pioneering regional study are expected to provoke a shift in standard ERCP practices, successfully lowering patient complication rates and shortening hospital stays. Furthermore, it will build the first dedicated database from the Gulf region to drive future meta-analyses and advance advanced gastrointestinal research.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ERCP , no intervention | No intervention | – |
| Post ERCP flushing | Experimental | Procedure: Ice cold water flushing post ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults (agesld 18 years old) scheduled for an endoscopic sphincterotomy at the participating hospitals.
Key exclusion criteria (1 listed)
- Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent.
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 |
|---|---|---|
| Ice cold water flushing post ERCP250 mL ice-cold water flush of the ampulla following sphincterotomy, | Procedure or surgery | Post ERCP flushing |
Primary outcome
Assess whether ice cold water flushing of the ampulla after ERCP reduces incidence of post ERCP pancreatitis compared to no flushing.
Time frame: 30 days
The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis. Specific Objectives: * Procedure Efficiency: Compare the time required, success rate of cannulation, and rate of pancreatic stenting between patients who receive the ice-cold water flush and those who do not. * Complication Rates: Contrast post-sphincterotomy complications and the specific severity of post-procedure pancreatitis between the two groups. * Recovery and Burden: Compare the total length of hospital stay and the frequency of hospital revisits within 4 weeks post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ice cold water flushing post ERCP in people with Post ERCP Pancreatitis, run by Oman Ministry of Health.
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: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Assess whether ice cold water flushing of the ampulla after ERCP reduces incidence of post ERCP pancreatitis compared to no flushing. (time frame: 30 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 30 Jun 2026.