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Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis (ERPNEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01767233
Recruitment Status : Unknown
Verified January 2013 by University of Oulu.
Recruitment status was:  Recruiting
First Posted : January 14, 2013
Last Update Posted : January 14, 2013
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
University of Oulu

Brief 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.

Condition or disease Intervention/treatment
Acute Necrotizing Pancreatitis Procedure: ERCP and pancreatic stenting

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis: a Prospective Randomized Controlled Multicenter Study
Study Start Date : January 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pancreatic stenting
Pancreatic stenting versus observation
Procedure: ERCP and pancreatic stenting

Primary Outcome Measures :
  1. The need for percutaneous, endoscopic, laparoscopic, or open surgical drainage and/or debridement after randomization. [ Time Frame: 12 months ]

    The indications for drainage/debridement are:

    1. Infection
    2. Gastro-intestinal or bile duct obstruction
    3. Pain caused by pancreatic or peripancreatic collection(s)
    4. Leakage of pancreatic juice (i.e. ascites or pleural fluid with an amylase content greater than 3 times the serum amylase activity)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01767233

Contact: Heikki K Karjula, MD + 358 08 3152830 heikki.karjula@ppshp.fi
Contact: Arto O Saarela, PhD + 358 08 3152809 arto.saarela@ppshp.fi

Oulu University Hospital Recruiting
Oulu, Finland, 90029
Contact: Jyrki Mäkelä, Professor    + 358 08 3152011    jyrki.makela@ppshp.fi   
Sponsors and Collaborators
University of Oulu
Copenhagen University Hospital, Hvidovre

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01767233     History of Changes
Other Study ID Numbers: 36/2010
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013

Keywords provided by University of Oulu:
Acute necrotizing pancreatitis
Pancreatic stenting

Additional relevant MeSH terms:
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases