Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis (ERPNEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Oulu
Sponsor:
Collaborator:
Copenhagen University Hospital, Hvidovre
Information provided by (Responsible Party):
University of Oulu
ClinicalTrials.gov Identifier:
NCT01767233
First received: January 10, 2013
Last updated: January 11, 2013
Last verified: January 2013
  Purpose

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 Intervention
Acute Necrotizing Pancreatitis
Procedure: ERCP and pancreatic stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis: a Prospective Randomized Controlled Multicenter Study

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • The need for percutaneous, endoscopic, laparoscopic, or open surgical drainage and/or debridement after randomization. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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)


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pancreatic stenting
Pancreatic stenting versus observation
Procedure: ERCP and pancreatic stenting

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767233

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

Locations
Finland
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
  More Information

No publications provided

Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT01767233     History of Changes
Other Study ID Numbers: 36/2010
Study First Received: January 10, 2013
Last Updated: January 11, 2013
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

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

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

ClinicalTrials.gov processed this record on October 23, 2014