Prophylactic Pancreatic Duct Stenting in Acute Necrotizing Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

NCT04408482

Endoscopic Retrograde Cholangiopancreatography

RECRUITING NA

Impact of Transmural Plastic Stent on Recurrence of Pancreatic Fluid Collection After Metal Stent Removal in Disconnected Pancreatic Duct

NCT03436043

Acute Pancreatitis Necrotizing

COMPLETED NA

Post-ERCP Pancreatitis Prevention by Stent Insertion

NCT01673763

Post-ERCP Acute Pancreatitis

COMPLETED NA

Evaluation of Pancreatic Duct Stenting in Patients With Pancreatic Pseudocysts.

NCT01276002

Chronic Acute Pancreatitis

WITHDRAWN NA

Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

NCT01449084

Acute Pancreatitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Necrotizing Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pancreatic stenting

Pancreatic stenting versus observation

Group Type EXPERIMENTAL

ERCP and pancreatic stenting

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ERCP and pancreatic stenting

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No