A novel lumen-apposing metal stent with an anti-reflux valve for endoscopic ultrasound-guided drainage of pseudocysts and walled-off necrosis: A pilot study

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Abstract

Background

Pancreatic pseudocysts (PC) and walled-off necrosis (WON) are common complications of severe pancreatitis. Endoscopic ultrasound (EUS)-guided drainage has replaced surgery as the standard treatment for PC/WON. We developed a novel lumen-apposing metal stent (LAMS) with an anti-reflux valve to prevent infectious complications caused by food reflux into the cyst cavity. This retrospective study investigated the efficacy and safety of EUS-guided drainage using this LAMS.

Methods

We investigated and compared the treatment outcomes and complications rates between EUS-guided drainage using a novel LAMS (n = 10) versus plastic stents (n = 18) from December 2013 to October 2016. Technical success was defined as successful stent placement without immediate complications. Clinical success was defined as resolution of the PC/WON and disappearance of symptoms.

Results

Among 10 patients in LAMS group, 4 patients had complicated PC and 6 patients had WON. In the plastic stent group, 15 and 3 patients had PC and WON, respectively. The median fluid collection size before treatment was 82.5 (interquartile range [IQR], 60.75–118.25) mm and 92.0 (IQR, 75.75–130.25) mm in the LAMS and plastic stent groups, respectively. There were no statistically significant differences in technical success rates (90% vs. 94.4%; p = 0.999), clinical success rates (80% vs. 77.8%; p = 0.999), and complication rates (20% vs. 27.8%; p = 0.999) between the two groups.

Conclusions

Treatment outcomes of EUS-guided drainage using a novel LAMS were feasible despite the significantly high proportion of WON. The LAMS allowed acceptable treatment outcomes for EUS-guided drainage.

Related collections

Most cited references 32

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Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study).

T Wehrmann, H Seifert, C Kreitmair … (2009)

As with endoscopic transmural drainage of peripancreatic fluid collections, the same transluminal access can be expanded to introduce an endoscope through the gastrointestinal wall into the retroperitoneum and remove infected pancreatic necroses under direct visual control. This study reports the first large series with long-term follow-up. Data for all patients undergoing transluminal endoscopic removal of (peri)pancreatic necroses between 1999 and 2005 in six different centres were collected retrospectively, and the patients were followed up prospectively until 2008. The initial patient and treatment outcome data were recorded, as were long-term results. Ninety-three patients (63 men, 30 women; mean age 57 years) underwent a mean of six interventions starting at a mean of 43 days after an attack of severe acute pancreatitis. After establishment of transluminal access to the necrotic cavity and subsequent endoscopic necrosectomy, initial clinical success was obtained in 80% of the patients, with a 26% complication and a 7.5% mortality rate at 30 days. After a mean follow-up period of 43 months, 84% of the initially successfully treated patients had sustained clinical improvement, with 10% receiving further endoscopic and 4% receiving surgical treatment for recurrent cavities; 16% suffered recurrent pancreatitis. Direct transluminal endoscopic removal of pancreatic necroses is associated with good long-term maintenance of the high initial efficacy; complications can occur, with an associated mortality of around 7.5%. Further studies are necessary in order to optimise endotherapy and define its role in relation to surgery in the clinical management of such patients.

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Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success.

Thomas E Kowalski, Laura Isby, Ali Siddiqui … (2017)

Endoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents (FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs.

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Compared with parenteral nutrition, enteral feeding attenuates the acute phase response and improves disease severity in acute pancreatitis.

F Welsh, P Guillou, Ronald A. Li … (1998)

In patients with major trauma and burns, total enteral nutrition (TEN) significantly decreases the acute phase response and incidence of septic complications when compared with total parenteral nutrition (TPN). Poor outcome in acute pancreatitis is associated with a high incidence of systemic inflammatory response syndrome (SIRS) and sepsis. To determine whether TEN can attenuate the acute phase response and improve clinical disease severity in patients with acute pancreatitis. Glasgow score, Apache II, computed tomography (CT) scan score, C reactive protein (CRP), serum IgM antiendotoxin antibodies (EndoCAb), and total antioxidant capacity (TAC) were determined on admission in 34 patients with acute pancreatitis. Patients were stratified according to disease severity and randomised to receive either TPN or TEN for seven days and then re-evaluated. SIRS, sepsis, organ failure, and ITU stay, were globally improved in the enterally fed patients. The acute phase response and disease severity scores were significantly improved following enteral nutrition (CRP: 156 (117-222) to 84 (50-141), p < 0.005; APACHE II scores 8 (6-10) to 6 (4-8), p < 0.0001) without change in the CT scan scores. In parenterally fed patients these parameters did not change but there was an increase in EndoCAb antibody levels and a fall in TAC. Enterally fed patients showed no change in the level of EndoCAb antibodies and an increase in TAC. TEN moderates the acute phase response, and improves disease severity and clinical outcome despite unchanged pancreatic injury on CT scan. Reduced systemic exposure to endotoxin and reduced oxidant stress also occurred in the TEN group. Enteral feeding modulates the inflammatory and sepsis response in acute pancreatitis and is clinically beneficial.

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Author and article information

Contributors

In Rae Cho: Role: InvestigationRole: Writing – original draft

Moon Jae Chung:

ORCID: http://orcid.org/0000-0002-5920-8549

Role: ConceptualizationRole: InvestigationRole: MethodologyRole: Supervision

Jung Hyun Jo: Role: Data curationRole: Investigation

Hee Seung Lee: Role: MethodologyRole: Validation

Jeong Youp Park: Role: Data curationRole: Investigation

Seungmin Bang: Role: SupervisionRole: Validation

Seung Woo Park: Role: SupervisionRole: Validation

Si Young Song: Role: Supervision

Haydar Celik: Role: Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 4 September 2019

Publication date Collection: 2019

Volume: 14

Issue: 9

Electronic Location Identifier: e0221812

Affiliations

[1 ] Department of Internal Medicine, Catholic Kwandong University College of Medicine, Incheon, Korea

[2 ] Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea

National Institutes of Health, UNITED STATES

Author notes

Competing Interests: The authors have declared that no competing interests exist.

* E-mail: mjchung@ 123456yuhs.ac

Author information

Moon Jae Chung http://orcid.org/0000-0002-5920-8549

Article

Publisher ID: PONE-D-19-06155

DOI: 10.1371/journal.pone.0221812

PMC ID: 6726198

PubMed ID: 31483821

SO-VID: 891ffa6c-c642-42f7-be00-17599fc02a2c

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

History

Date received : 2 March 2019

Date accepted : 15 August 2019

Page count

Figures: 3, Tables: 2, Pages: 12

Funding

Funded by: National Research Foundation of Korea

Award ID: 2017R1D1A1B03033951

Award Recipient :

ORCID: http://orcid.org/0000-0002-5920-8549

Moon Jae Chung

This research was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF https://www.nrf.re.kr/) funded by the Ministry of Education 2017 (2017R1D1A1B03033951). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Custom metadata

Data Availability All relevant data are within the paper. Additional data cannot be shared publicly as they contain potentially identifying patient data (restricted by the Institutional Review Board of Severance Hospital). Qualified, interested researchers can contact medstudy@ 123456yuhs.ac to request additional data.

A novel lumen-apposing metal stent with an anti-reflux valve for endoscopic ultrasound-guided drainage of pseudocysts and walled-off necrosis: A pilot study

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Abstract

Background

Methods

Results

Conclusions

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Most cited references 32

Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study).

Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success.

Compared with parenteral nutrition, enteral feeding attenuates the acute phase response and improves disease severity in acute pancreatitis.

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