FLUYT-prevent trial

Not Applicable

Completed

• Conditions: Choledocholithiasis and other conditions requiring endoscopic retrograde cholangiopancreatography (ERCP); Digestive System; Choledocholithiasis

• Registration Number: ISRCTN13659155
• Lead Sponsor: Radboud University Medical Center

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29606135 2021 results in https://pubmed.ncbi.nlm.nih.gov/33740415/ (added 22/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-18
• Study Completion: 2019-12-03
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 826

Inclusion Criteria

1. Requiring ERCP
2. Between 18 and 85 years of age
3. Signed informed consent

Exclusion Criteria

1. Allergy to NSAIDs or other contraindications
2. Ongoing acute pancreatitis
3. Ongoing hypotension, including those with sepsis
4. Cardiac insufficiency (CI, >NYHA Class I heart failure)
5. Renal insufficiency (RI, creatinin clearance <40ml/min)
6. Active ulcer disease
7. Severe liver dysfunction: liver cirrhosis and ascites
8. Respiratory insufficiency (pO2<60mmHg or 90% despite FiO2 of 30% or requiring mechanical ventilation)
9. Pregnancy
10. Hyponatremia (Na+ levels < 130mmol/l)
11. Hypernatremia (Na+ levels > 150mmol/l)
12. Oedema
13. Low risk of PEP: chronic calcific pancreatitis (PD intervention is allowed) or pancreatic head mass or routine biliary stent exchange or re-ERCP with a history of endoscopicsphincterotomy with a CBD intervention (PD intervention is allowed)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-ERCP pancreatitis, according to Cotton criteria

Secondary Outcome Measures

Name	Time	Method
<br> 1. Severity of post-ERCP pancreatitis measured at discharge (Cotton criteria)<br> 2. Severe morbidity (Atlanta criteria) or death measured at discharge<br> 3. ERCP related complications within 48 hours after ERCP<br> 4. Fluid hydration related complications within 24 hours after ERCP or at the latest at discharge<br> 5. Length of hospital stay (including stay on the intensive care unit) measured after a follow up period of 6 months (so readmissions can be taken into account)<br> 6. Direct and indirect costs measured after 6 months of follow up<br> 7. Risk factors for developing post-ERCP pancreatitis measured at baseline<br> 8. Generic health-related quality of life measured with EQ5D and SF36<br> 9. Exocrine and endocrine pancreatic insufficiency at 180 days: fecal elastase-1 and HbA1c<br> 10. Incidence of delayed post-ERCP pancreatitis<br>