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Lumen Apposing Metal Stents vs Double Pigtail Stents

2019-08-20 20:17:10 | BioPortfolio

Summary

While the majority of patients with acute pancreatitis suffer a mild and uncomplicated course of disease, up to 20% develop a more severe course with development of pancreatic and/or peripancreatic necroses. With time, these necroses become encapsulated with a well-defined inflammatory wall, so called walled-off necroses (WON). Up to 30% of WONs become infected, which prolongs the length of hospital stay, increases morbidity and mortality significantly, and generally requires an invasive intervention. During the last decade, minimally invasive therapies consisting of percutaneous and endoscopic, transluminal drainage followed, if necessary, by percutaneous or endoscopic necrosectomy, have replaced open surgery as the standard treatment resulting in better patient outcomes. The investigators have for nearly two decades been practicing an endoscopic step-up approach as standard treatment for infected WON.

Recently, lumen apposing metal stents (LAMS) have been introduced for the treatment of pancreatic fluid collections. The stent is fully-covered and shaped with two bilateral anchor flanges with a saddle in between. A dedicated through-the-scope delivery system, where the tip serves as an electro cautery device enables extra-luminal access and deployment of the stent. Initial results from primarily retrospective case series were promising. However, a recent randomized controlled trial failed to demonstrate superiority in terms of number of necrosectomies needed, treatment success, clinical adverse events, readmissions, length of hospital stay (LOS), and overall treatment costs. Furthermore, a number of serious adverse events with development of pseudoaneurisms probably due to collapse of the cavity have led to alterations in treatment with sequential computed tomography (CT) scans and insertion of double pigtail stents within the metal stent. In that trial, the mean diameter of the treated necroses was limited and in addition, the study was launched before the introduction of a novel 20 mm in diameter LAMS. The investigators hypothesize, that use of a 20 mm LAMS in large caliber WON is superior to the standard double pigtail technique.

Aim To compare the use of a novel 20 mm lumen apposing metal stent (LAMS) (Hot Axios, Boston Scientific) with a conventional double pigtail technique for endoscopic transluminal drainage of large (> 15 cm) pancreatic and/or peripancreatic walled-of necrosis (WON).

Study Design

Conditions

Pancreatitis,Acute Necrotizing

Intervention

EUS guided transgastric drainage

Location

Copenhagen University Hospital Hvidovre
Hvidovre
Capital
Denmark
2650

Status

Not yet recruiting

Source

Copenhagen University Hospital, Hvidovre

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-20T20:17:10-0400

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the PANCREAS. Pancreatitis is classified as acute unless there are computed tomographic or endoscopic retrograde cholangiopancreatographic findings of CHRONIC PANCREATITIS (International Symposium on Acute Pancreatitis, Atlanta, 1992). The two most common forms of acute pancreatitis are ALCOHOLIC PANCREATITIS and gallstone pancreatitis.

A severe form of acute INFLAMMATION of the PANCREAS characterized by one or more areas of NECROSIS in the pancreas with varying degree of involvement of the surrounding tissues or organ systems. Massive pancreatic necrosis may lead to DIABETES MELLITUS, and malabsorption.

Acute or chronic INFLAMMATION of the PANCREAS due to excessive ALCOHOL DRINKING. Alcoholic pancreatitis usually presents as an acute episode but it is a chronic progressive disease in alcoholics.

A syndrome characterized by acute OPTIC NEURITIS in combination with acute MYELITIS, TRANSVERSE. Demyelinating and/or necrotizing lesions form in one or both optic nerves and in the spinal cord. The onset of optic neuritis and myelitis may be simultaneous or separated by several months. (J Neurol Neurosurg Psychiatry 1996 Apr;60(4):382-387)

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