JPRN-jRCTs031200202
Recruiting
Phase 2
Examination of post-ERCP pancreatitis preventive effect of load infusion therapy with lactated Ringer's solutionRandomized controlled trial
Kurita Yusuke0 sites950 target enrollmentNovember 16, 2020
ConditionsBiliary-pancreatic diseases for which ERCP is indicatedCholedocholithiasis, acute cholangitis, acute cholecystitis, cholangiocarcinoma, primary sclerosing cholangitis, IgG4-related sclerosing cholangitis, pancreatic cancer, autoimmune pancreatitis, pancreatic duct stricture, cystic pancreatic tumor
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Biliary-pancreatic diseases for which ERCP is indicated
- Sponsor
- Kurita Yusuke
- Enrollment
- 950
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Patients aged 20 to 85 at the time of consent acquisition
- •(2\) Gender: Any
- •(3\) Patients who are clinically indicated for ERCP and undergo ERCP (malignant biliary stricture, pancreatic cancer, acute cholangitis, common bile duct stone, IgG4 sclerosing cholangitis, primary sclerosing cholangitis, etc.)
- •(4\) Post\-ERCP pancreatitis risk (moderate or higher)
- •(5\) PS is 2 or less
- •(6\) Patients who can take oral drugs, meals and beverages
- •(7\) Patients expected to have stable primary disease (including cancer) 6 months after registration during the observation period
- •(8\) Patients who have written informed consent to participate in this study, who comply with the compliance items during this study participation, who can receive the medical examination prescribed in this study plan and report symptoms etc.
Exclusion Criteria
- •(1\) Patients with low risk of post\-ERCP pancreatitis (confirmed cases of chronic pancreatitis, pancreatic head tumor, periodic biliary stent replacement)
- •(2\) Patients with acute pancreatitis
- •(3\) Patients with hypotension including sepsis
- •(4\) Heart failure patients (NYHA Class II or above)
- •(5\) Patients with renal failure (creatinine clearance \<30 mL/min)
- •(6\) Patients with liver failure (patients with cirrhosis and ascites)
- •(7\) Patients with respiratory failure (defined as oxygen saturation \<90%)
- •(8\) Hyponatremia (Na\+ levels \<130mEq/L)
- •(9\) Hypernatremia (Na\+ levels\> 150mEq/L)
- •(10\) Hypokalemia (K\+ levels \<3\.0mEq/L)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
The use of post-ERCP pancreatitis prophylaxis and recognition of risk factors for post-ERCP pancreatitis among Dutch gastroenterologists: a nationwide practice surveyPost-ERCP pancreatitisNL-OMON22181Radboud university medical center150
Completed
Phase 4
Rectal Indomethacin vs Intravenous KetorolacPost-ERCP Acute PancreatitisNCT05664074David Vitale MD192
Recruiting
Not Applicable
Prophylaxis of post-ERCP pancreatitis by the intravenous administration of the non-steroidal anti-inflammatory drugPost-ERCP pancreatitisJPRN-UMIN000013193Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine, Tokyo, Japan400
Completed
Phase 3
Effectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent -randomized controlled multicenter trialEffectiveness of prophylaxis of post-ERCP pancreatitis for risk group by an endoscopic pancreatic spontaneous dislodgement stent -randomized controlled multicenter trial-JPRN-UMIN000004324Japan Pancreatic Stent-Study Group (JPS-SG)500
Not yet recruiting
Not Applicable
Assessment of severity of post-ERCP pancreatitis by the drug pain score.Post-ERCP pancreatitisJPRN-UMIN000029279Kumamoto City Medical Association Health Care Center10,000