Prophylaxis of acute pancreatitis arising following ERCP (a procedure that uses endoscopy and radiology to study the bile and pancreatic ducts) comparing the administration of Indomethacin versus the combination of Indomethacin with Lactated Ringer.

Phase 1

• Conditions: Study objective: prophylaxis for Acute Pancreatitis post-ERCP (PEP). ERCP refers to endoscopic retrograde cholangiopancreatography: it is an endoscopic procedure using radiological imaging. It is used for the diagnosis and treatment of benign and malignant biliary and pancreatic diseases. The most common complication is acute post-ERCP pancreatitis (PEP).; MedDRA version: 20.0Level: PTClassification code 10033647Term: Pancreatitis acuteSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-004298-35-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

- Age > 18 years;
- All naïve patients consecutively undergoing ERCP and with any indication;
- Informed consent obtained.
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 1250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 625

Exclusion Criteria

- Refusal or inability to sign informed consent;
- Patients with ongoing acute pancreatitis;
- Patients with known allergy/hypersensitivity to NSAIDs;
- Patients with hypersensitivity to the active substance(s) or to any of the excipients of Ringer Lactate;
- Patients with a personal or family history of Stevens-Johnson syndrome or Lyell syndrome;
- Patients already treated with NSAIDs within 7 days prior to ERCP;
- Patients with recent gastrointestinal bleeding (less than 30 days after ERCP), or with a history of recurrent bleeding/ulcer peptic ulcer or bleeding/perforation after previous NSAID treatment;
- Patients undergoing endoscopic papillectomy;
- Patients with a positive history of recent myocardial infarction (less than 6 months after the procedure), heart failure, severe myocardial insufficiency (NYHA class > II), respiratory insufficiency with chronic need for oxygen therapy, known pulmonary hypertension;
- Patients with ventricular fibrillation;
- Patients with ongoing therapy with cardioactive glycosides;
- Patients with chronic renal insufficiency (creatinine clearance values below 40 ml/min);
- cirrhotic patients in Child B and C class;
- Patients with severe hydro-electrolyte imbalances (hypernatremia > 150 mEq/L, hyponatremia < 130 mEq/L; hypercalcemia, hyperkalemia).
- Metabolic and respiratory alkalosis;
- Patients with epilepsy or Parkinson's disease;
- Patients with psychiatric disorders;
- Patients with a history of major surgery of the upper digestive tract (Billroth II, Roux-en-Y anastomosis);
- Pregnancy or lactation;
- Sarcoidosis;
- Untreated Addison's disease;
- Active proctitis of any aetiology.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparing the incidence of PEP in patients undergoing ERCP and randomised to receive 2 different prophylaxis regimens;Secondary Objective: To evaluate the effect of the 2 different prophylaxis regimens on:<br>1.Severity of pancreatitis<br>2.Increase in amylase and lipase values <br>3.Occurrence of any adverse events<br>4.Average length of hospitalisation;Primary end point(s): The onset of post-ERCP acute pancreatitis (PEP);Timepoint(s) of evaluation of this end point: At 24 hours after the procedure (according to Cotton's criteria)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Severity of post-ERCP acute pancreatitis (PEP) according to Atlanta criteria; 2.Difference in plasma amylase and lipase level post-ERCP compared to baseline; 3.Intra- and post-procedural adverse events with particular reference to:<br>•intra-operative bleeding<br>•postoperative bleeding<br>•increased plasma creatinine compared to baseline<br>•pulmonary oedema <br>•water overload <br>•other; 4.Average length of stay;Timepoint(s) of evaluation of this end point: 72 hours after the onset of acute pancreatitis; At 24 hours; •Intra-operative bleeding (during surgery)<br>•Postoperative bleeding (within 30 days of the procedure);<br>•Increased plasma creatinine compared to baseline (at 24 hours post-procedure);<br>•Pulmonary oedema (2, 8 and 24 hours after the procedure);<br>•Water overload (2, 8 and 24 hours after the procedure);<br>•Other (events occurring during the hospital stay and related to the procedure or study).; Until the end of hospitalisation