Does MAP kinase inhibition with CNI-1493 prevent post-ERCP pancreatitis?

MAP kinase inhibition for the prevention of post-ERCP pancreatitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23715

Enrollment

270

Registered

2005-09-09

Start date

2002-03-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Patients with a need to undergo ERCP and a relatively high risk to develop post-ERCP pancreatitis.

Interventions

Single infusion of CNI-1493 (50 mg IV or placebo IV (randomized, double blind) 1 h 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 visualize the pancreatic duct; b. Perform therapeutic procedures (e.g. stenting, balloon dilatation, sphincter manometry, precut papillotomy, stone extraction, (intra-luminal) endosonography, 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 3 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 2.0 mg/dl (> 180 ƒÝM) (any state, contra indication); 9. Other anti-TNF therapy (eg, infliximab) within 8 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, 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, IL-8, TNF and IL-1 in high risk patients undergoing ERCP?

—

Contacts

Public ContactM.J. Bruno

Academical Medical Center (AMC), Department of Gastroenterology-Hepatology (MDL), P.O. Box 22660

m.j.bruno@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)