Cold Water Irrigation for Pancreatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether rinsing a specific area near the pancreas with cold water during a common procedure called ERCP can help prevent post-procedure pancreatitis. Participants will receive either cold water or room-temperature water to determine which is more effective in reducing risk. Individuals with a native papilla (a small opening in the duodenum) undergoing ERCP for diagnosis or treatment may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future pancreatitis prevention methods.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that Cold Water Irrigation Therapy is safe for use in ERCP procedures?
Research shows that cold water therapy could be a safe option. Previous studies have found that rinsing a small part of the intestine with cold water after an ERCP procedure helps lower the risk of pancreatitis. This method, which uses cold to prevent illness, has proven effective and safe. In one study, the risk of pancreatitis significantly decreased with cold water use, indicating that the treatment is well-tolerated and does not cause serious side effects. So far, evidence supports this therapy as a safe and promising technique.12345
Why are researchers excited about this trial?
Most treatments for pancreatitis focus on managing symptoms with pain relief, hydration, and sometimes antibiotics. However, Cold Water Irrigation Therapy offers a unique approach by directly applying cold water to the papilla, which may help reduce inflammation more directly. Researchers are excited about this method because it introduces a novel delivery system that could potentially target the source of inflammation more effectively than traditional systemic treatments. By using cold water, this technique could offer a less invasive and more immediate way to manage pancreatitis, making it a promising area of exploration.
What evidence suggests that cold water irrigation therapy is effective for reducing pancreatitis after ERCP?
Research has shown that using cold water after an ERCP procedure can reduce the risk of pancreatitis. In this trial, participants in the experimental arm will receive Cold Water Irrigation Therapy, which uses refrigerated water directed toward the papilla. One study found that this method lowered the risk by 3.6 percentage points, meaning that for every 28 patients treated with cold water, one case of pancreatitis was prevented. Another study also reported a significant drop in pancreatitis cases when using ice water, making it a safe, effective, and low-cost option. Overall, cold water shows promise in reducing the chances of developing pancreatitis after ERCP.12346
Who Is on the Research Team?
Reza Hejazi
Principal Investigator
University of Kansas
Are You a Good Fit for This Trial?
This trial is for individuals who have undergone an ERCP procedure, which is a type of endoscopic surgery used to examine the pancreatic and bile ducts. Participants should not currently be experiencing pancreatitis or pancreatic insufficiency.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ERCP with either cold water or room-temperature water irrigation after receiving rectal indomethacin
Post-Procedure Monitoring
Participants are monitored in the recovery unit and inpatient setting for signs of pancreatitis and other adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up for severity of post-ERCP pancreatitis
What Are the Treatments Tested in This Trial?
Interventions
- Cold Water Irrigation Therapy
Trial Overview
The study investigates if rinsing the papilla with cold water after an ERCP can reduce the risk of developing post-ERCP pancreatitis compared to using warm water, alongside standard medication like Indomethacin.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
• Cold Water Irrigation of the Papilla: Participants randomized to the experimental arm will receive 250 mL of refrigerated water (target temperature 4-8 °C) in five 50 mL aliquots directed toward the papilla, with duodenal aspiration after each aliquot.
• Control Intervention: Participants randomized to the control group will receive 250 mL of room-temperature water in identical increments and delivery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
Citations
1.
gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/cryoprevention-reduces-incidence-of-post-ercp-pancreatitis/Cryoprevention Reduces Incidence of Post-ERCP ...
Overall, absolute risk reduction was 3.6 percentage points and RR reduction of 52.4%. The number needed to prevent 1 case of PEP was 28.
2.
journals.lww.com
journals.lww.com/ajg/abstract/9900/local_post_procedural_cryoprevention_significantly.1843.aspxLocal post-procedural cryoprevention significantly reduces...
Conclusions: Cryoprevention using ice water significantly reduced PEP incidence, demonstrating a safe, effective, and low-cost strategy. This approach offers a ...
Cold Water Irrigation for Pancreatitis · Info for Participants
The study investigates if rinsing the papilla with cold water after an ERCP can reduce the risk of developing post-ERCP pancreatitis compared to ...
Effect of ice water injection toward the duodenal papilla for ...
Our previous single-center prospective study suggested that cooling the papilla with ice water may reduce the incidence of PEP by 4% [14].
Update in preventing post-endoscopic retrograde ...
Effect of ice water injection toward the duodenal papilla for preventing post-ERCP pancreatitis: study protocol for a multicenter, single- ...
Effect of ice water injection toward the duodenal papilla for ...
This multicenter randomized controlled trial evaluated the efficacy and safety of ice water irrigation to the papilla in reducing PEP.
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