Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis

Acute Necrotizing Pancreatitis Clinical Trial

— ERPNEC  

Official title:

Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis: a Prospective Randomized Controlled Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01767233
• Other study ID #: 36/2010
• Status: Recruiting
• Phase: N/A
• First received: January 10, 2013
• Last updated: January 11, 2013
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2013
• Source: University of Oulu
• Contact: Heikki K Karjula, MD
• Phone: + 358 08 3152830
• Email: heikki.karjula[@]ppshp.fi
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial Summary

Since the majority of patients with necrotizing pancreatitis will experience a leak from the pancreatic duct during their course of disease resulting in intra- and peripancreatic fluid collections, it is reasonable to hypothesize that placement of a ductal stent may prevent some of the late complications and morbidity associated with pancreatic necrosis. This prospective, randomized, controlled multicenter trial investigates the role of early prophylactic ductal stenting in acute necrotizing pancreatitis.

The purpose of the study is to determinate the safety and feasibility of early prophylactic pancreatic duct stenting in necrotizing pancreatitis in reducing complications, length of stay in hospital and in in-tensive care unit compared to the traditional treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

In patients with suspected necrotizing pancreatitis a pancreatic protocol 3-phase contrast enhanced (CE) CT shall be performed. Since a very early CT may underestimate the extent of pancreatic necro-sis, it is recommended to wait at least 72 hours after the onset of symptoms before CT is done. The CECT may be repeated if the initial CT shows no necroses and the clinical course continues to indicate a severe case.

MRI may be used instead of CT in case of contraindication to intravenous contrast due to renal failure.

If CECT reveals pancreatic necrosis affecting the head, neck, or body of pancreas and the necrosis is suspected to include the main pancreatic duct an informed consent to participate in the study is ob-tained, after which the patient will be randomized to either a) the control group with traditional treat-ment (i.e. at the discretion of each participating center) or to b) the intervention group with same treatment as in the control group plus ERP and PD-stenting. Patients with isolated necrosis of the tail will not be included in the study.

Exclusion Criteria:

All consecutive patients (age between 18-75 years) admitted to the participating centers for acute pan-creatitis with an area of non-enhancing pancreatic parenchyma on CT believed to represent necrosis are prospectively enrolled in the study. At initial presentation the age, gender, etiology of the pancreatitis, clinical and laboratory findings will be recorded. Patients with malignancies and patients from whom an informed consent to participate in the study cannot be obtained will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

Procedure:
• ERCP and pancreatic stenting

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The need for percutaneous, endoscopic, laparoscopic, or open surgical drainage and/or debridement after randomization.	The indications for drainage/debridement are: Infection; Gastro-intestinal or bile duct obstruction; Pain caused by pancreatic or peripancreatic collection(s); Leakage of pancreatic juice (i.e. ascites or pleural fluid with an amylase content greater than 3 times the serum amylase activity)	12 months	Yes