Does mitogen activated protein kinase inhibition with CNI-1493 prevent post-Endoscopic retrograde cholangiopancreatography pancreatitis?

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP), pancreatitis; Digestive System; Disorders of gallbladder, biliary tract and pancreas

• Registration Number: ISRCTN26235881
• Lead Sponsor: Cytokine PharmaSciences, Inc (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2005-12-31
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 270

Inclusion Criteria

1. Included are all patients who do not fit the exclusion criteria and will undergo an ERCP with the intention to:
a. cannulate and visualise the pancreatic duct
b. perform therapeutic procedures (e.g. stenting, balloon dilatation, sphincter manometry, precut papillotomy, stone extraction, (intra-luminal) endosonography, Extracorporeal Shock-Wave Lithotripsy [ESWL] and dilatation) in the pancreatic duct, common bile duct or left and right hepatic ducts
2. Patients must agree to use acceptable means of birth control for at least three months after the procedure
3. Patients must sign informed consent

Exclusion Criteria

1. Diagnostic ERCP (low risk)
2. Active pancreatitis at time of ERCP (confounding)
3. Severe abdominal pain pre ERCP (confounding)
4. Age less than 18 years (contra-indication)
5. Known or suspected pregnancy or breast-feeding (contra-indication)
6. ERCP for stent exchange in malignant disease (low risk)
7. Severe chronic pancreatitis (low risk)
8. Kidney failure i.e. serum creatinine greater than 20 mg/dl (greater than 180 µM) (any state, contra-indication)
9. Other anti-TNF therapy (e.g. infliximab) within eight weeks of intended study treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does administration of CNI-1493 decrease the incidence of post ERCP pancreatitis in high risk patients undergoing ERCP?

Secondary Outcome Measures

Name	Time	Method
<br> 1. Is CNI-1493 administration safe in patients undergoing ERCP?<br> 2. Does administration of CNI-1493 decrease the severity of post ERCP pancreatitis in high risk patients undergoing ERCP?<br> 3. Does administration of CNI-1493 decrease the incidence of post ERCP hyperamylasemia in high risk patients undergoing ERCP?<br> 4. Does administration of CNI-1493 decrease the levels of post ERCP IL-6, Interleukin-eight (IL-8), TNF and IL-1 in high risk patients undergoing ERCP?<br>