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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26235881

Enrollment

270

Registered

2005-12-20

Start date

2002-03-01

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Single infusion of CNI-1493 (50 mg intravenous [IV] or placebo IV (randomised, double blind) one hour prior to start of ERCP.

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Does administration of CNI-1493 decrease the incidence of post ERCP pancreatitis in high risk patients undergoing ERCP?	—

Secondary

Measure	Time frame
1. Is CNI-1493 administration safe in patients undergoing ERCP? 2. Does administration of CNI-1493 decrease the severity of post ERCP pancreatitis in high risk patients undergoing ERCP? 3. Does administration of CNI-1493 decrease the incidence of post ERCP hyperamylasemia in high risk patients undergoing ERCP? 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?	—

Measure

Time frame

1. Is CNI-1493 administration safe in patients undergoing ERCP? 2. Does administration of CNI-1493 decrease the severity of post ERCP pancreatitis in high risk patients undergoing ERCP? 3. Does administration of CNI-1493 decrease the incidence of post ERCP hyperamylasemia in high risk patients undergoing ERCP? 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?

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026