NCT04057846

Lumen Apposing Metal Stents vs Double Pigtail Stents

Completed NA Last updated 2 August 2022

What this trial tests

NA trial testing EUS guided transgastric drainage in Pancreatitis,Acute Necrotizing in 42 participants. Completed in 31 May 2022.

Timeline

29 August 2019

Primary endpoint
31 May 2022

31 May 2022

Quick facts

Lead sponsor	John Gasdal Karstensen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	29 August 2019
Primary completion	31 May 2022
Estimated completion	31 May 2022
Sites	1 location across Denmark

Drugs / interventions tested

• EUS guided transgastric drainage

Conditions studied

• Pancreatitis,Acute Necrotizing — all drugs for Pancreatitis,Acute Necrotizing →

Sponsor

John Gasdal Karstensen

Who can join

18 and older, any sex, with Pancreatitis,Acute Necrotizing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial.
   Karstensen JG, Novovic S, Hansen EF, Jensen AB, et al · · 2023 · cited 53× · PMID 36446550 · DOI 10.1136/gutjnl-2022-328225