intravenous fluid administration to prevent pancreatic inflammation following endoscopic bile duct examination.

Phase 1

Conditions: Patients with choledocholithiasis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2015-000829-37-NL

Lead Sponsor: Radboud University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 826

Inclusion Criteria

Age between 17 and 86
written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

1) Allergy to NSAID’s or other contraindications
2) Ongoing acute pancreatitis
3) Ongoing hypotension, including those with sepsis
4) Cardiac insufficiency (CI, >NYHA Class II 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 or pancreatic head mass or routine biliary stent exchange; re-ERCP with a history of endoscopic sphincterotomy with a CBD intervention (PD intervention is allowed)
14) Planned prophylactic pancreatic stent placement

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether administration of large volumes of intravenous ringer's lactated solution, on top of rectal NSAID's, can reduce the risk of post-ERCP pancreatitis (PEP), as compared with current practice of administration of only rectal NSAID's and no or small amount of saline solution.;Secondary Objective: To investigate between the two groups 1) severity of PEP (mild, moderate, severe), 2) severe morbidity or mortality, 3) ERCP related complications, 4) complications of intravenous hydration, 5) length of hospital stay (including ICU), 6) differences in costs, 7) quality of life scores.;Primary end point(s): Post-ERCP pancreatitis;Timepoint(s) of evaluation of this end point: 48 hours after ERCP

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) severity of PEP (mild, moderate, severe), 2) severe morbidity or death, 3) ERCP related complications (eg bleeding, perforation) 4) fluid administration related complications (pulmonary or peripheral edema, hypernatremia), 5) length of stay, 6) costs (direct and indirect), 7) Quality of life scores.;Timepoint(s) of evaluation of this end point: varies between endpoints