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Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis (ERPNEC)

Primary Purpose

Acute Necrotizing Pancreatitis

Status

Unknown status

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

ERCP and pancreatic stenting

About this trial

This is an interventional prevention trial for Acute Necrotizing Pancreatitis focused on measuring Acute necrotizing pancreatitis, ERCP, Pancreatic stenting

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oulu University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pancreatic stenting

Arm Description

Pancreatic stenting versus observation

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT01767233

First Posted

January 10, 2013

Last Updated

January 11, 2013

Sponsor

University of Oulu

Collaborators

Copenhagen University Hospital, Hvidovre

1. Study Identification

Unique Protocol Identification Number

NCT01767233

Brief Title

Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis

Acronym

ERPNEC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Oulu

Collaborators

Copenhagen University Hospital, Hvidovre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Necrotizing Pancreatitis

Keywords

Acute necrotizing pancreatitis, ERCP, Pancreatic stenting

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pancreatic stenting

Arm Type

Experimental

Arm Description

Pancreatic stenting versus observation

Intervention Type

Procedure

Intervention Name(s)

ERCP and pancreatic stenting

Primary Outcome Measure Information:

Title

The need for percutaneous, endoscopic, laparoscopic, or open surgical drainage and/or debridement after randomization.

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heikki K Karjula, MD

Phone

+ 358 08 3152830

heikki.karjula@ppshp.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Arto O Saarela, PhD

Phone

+ 358 08 3152809

arto.saarela@ppshp.fi

Facility Information:

Facility Name

Oulu University Hospital

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jyrki Mäkelä, Professor

Phone

+ 358 08 3152011

jyrki.makela@ppshp.fi

12. IPD Sharing Statement

Citations:

PubMed Identifier

30895583

Citation

Karjula H, Nordblad Schmidt P, Makela J, Liisanantti JH, Ohtonen P, Saarela A. Prophylactic pancreatic duct stenting in severe acute necrotizing pancreatitis: a prospective randomized study. Endoscopy. 2019 Nov;51(11):1027-1034. doi: 10.1055/a-0865-1960. Epub 2019 Mar 20.

Results Reference

derived

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Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis

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