Lumen Apposing Metal Stents vs Double Pigtail Stents

NCT04057846 | Completed DMC FDA Device

• 1 other identifier: LAMS vs DPT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pancreatitis,Acute Necrotizing

Keywords

Walled of necrosis; Endoscopic drainage; Lumen apposing metal stents

Outcome Measures

Primary Outcomes (1)

• Number of necrosectomies

  Number of debridement procedures (endoscopic and video-assisted) needed throughout the disease course.

  Through study completion, an average of 2 year

Secondary Outcomes (15)

• Number of endoscopic procedures

  Through study completion, an average of 6 months

• Total number of drainage and debridement procedures (radiological, endoscopic, and surgical)

  Through study completion, an average of 6 months

• Number of days from index drainage procedure until removal of naso-cystic catheter

  Through study completion, an average of 6 months

• Duration of drainage and debridement procedures

  Through study completion, an average of 6 months

• Length of hospital stay from the index drainage procedure

  Through study completion, an average of 6 months

Study Arms (2)

Double pigtail

ACTIVE COMPARATOR

Plastic stent group EUS-guided drainage shall be performed as follows: a) Puncture of WON with a 19 GA Access needle (Cook Medical), b) aspiration of fluid in WON for microbiological assessment, c) insertion of guidewire (0.035 inch, 450 cm, Dreamwire (Boston Scientific), d) creation of transmural tract with needle knife over the guidewire, e) dilatation of tract to a diameter of 15 mm with dilation balloon (EZDilate, Olympus), f) insertion of two 7-Fr/6 cm double pigtail stents and a 7-Fr naso-cystic irrigation catheter.

Device: EUS guided transgastric drainage

Lumen apposing metal stent

EXPERIMENTAL

LAMS shall be the Hot AXIOS stent with electrocautery-enhanced delivery system (Boston Scientific). The stent is a through-the-scope, fully covered, self-expandable metal stents with a diameter of 20 mm and a length of 10 mm. Before placement of the LAMS, the WON shall be punctured with a 19 GA Access needle (Cook Medical) and fluid in WON aspirated for microbiological assessment. Thereafter the LAMS shall be placed as follows: After directly puncturing the WON using the electrocautery tip (without the use of a guidewire to assist in stent insertion), the delivery catheter is advanced into the WON and the distal flange is deployed under EUS-guidance. The proximal flange is then released under EUS guidance or endoscopic view. After placement of the LAMS, a 7-Fr/4cm double pigtail and a 7-Fr nasocystic irrigation catheter shall be placed through the LAMS.

Device: EUS guided transgastric drainage

Interventions

EUS guided transgastric drainage DEVICE

Whenever possible, randomisation and intervention shall be postponed until 4 weeks after onset of pancreatitis in line with international guidelines. All procedures in this study shall be performed by three experienced endoscopists (PNS, EFH, SN), who all have an extensive experience in endoscopic ultrasound (EUS-) guided drainage of pancreatic collections and the use of self-expanding stents. They have together performed more than 300 endoscopic, transmural drainage and debridement procedures in patients with WON since 2005. Endosonography-guided, transgastric drainage of the WONs shall be performed using a curve-linear echoendoscope (endoscope: Olympus GF-UCT180; ultrasound scanner: Hitachi Arietta 850 or Olympus EU-ME2). All collections shall be treated by single tract transmural cystogastrostomy (single-gate technique). T

Double pigtail; Lumen apposing metal stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute, necrotizing pancreatitis and
• WON exceeding a diameter of 15 cm (measured on contrast-enhanced CT (CECT); see details on imaging tests below). WON is defined based on the revised Atlanta criteria as a mature, encapsulated pancreatic or peripancreatic necrosis with a well-defined inflammatory wall\[12\].
• Imaging test(s) must be done within 1 week before the index drainage procedure.
• Debut of pancreatitis must be within 3 months before the index drainage procedure.
• One or more indication(s) for endoscopic, transmural drainage must be established:
• \. Confirmed or suspected infection.1 2. Severe intraabdominal hypertension or abdominal compartment syndrome. 3. Persisting abdominal pain, early satiety, or general discomfort. 4. Obstruction of the GI or biliary tract. 5. Leakage of pancreatic juice, e.g. ascites or pleural effusion.
• \. Preoperatively, the WON must be considered eligible for endoscopic, transgastric drainage with both conventional double pigtail and LAMS technique. Distance between the gastric wall and WON must not exceed one cm and there must be no major interposed vessels.
• Infection in WON:
• Confirmed infected necrosis is defined as a) positive culture from WON obtained by fine- needle aspiration prior to or at the first drainage procedure or b) presence of gas in WON on CECT prior to drainage with no earlier puncture/drainage and no signs of perforation to the GI tract.
• Infected necrosis is suspected when a patient with WON present with clinical signs of persistent sepsis without other causes of infection.

You may not qualify if:

• Patients under the age of 18.
• Pregnancy.
• Known or suspected malignant disease.
• Pancreatitis secondary to trauma or surgical intervention.
• Chronic pancreatitis.
• Collections that may only be drained from the duodenum.
• Previous surgical or endoscopic drainage or necrosectomy.

Sponsors & Collaborators

• John Gasdal Karstensen: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, Capital, 2650, Denmark

Location

Related Publications (7)

• van Dijk SM, Hallensleben NDL, van Santvoort HC, Fockens P, van Goor H, Bruno MJ, Besselink MG; Dutch Pancreatitis Study Group. Acute pancreatitis: recent advances through randomised trials. Gut. 2017 Nov;66(11):2024-2032. doi: 10.1136/gutjnl-2016-313595. Epub 2017 Aug 24.

  PMID: 28838972 BACKGROUND

• Banks PA, Freeman ML; Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines in acute pancreatitis. Am J Gastroenterol. 2006 Oct;101(10):2379-400. doi: 10.1111/j.1572-0241.2006.00856.x. No abstract available.

  PMID: 17032204 BACKGROUND

• Yan L, Dargan A, Nieto J, Shariaha RZ, Binmoeller KF, Adler DG, DeSimone M, Berzin T, Swahney M, Draganov PV, Yang DJ, Diehl DL, Wang L, Ghulab A, Butt N, Siddiqui AA. Direct endoscopic necrosectomy at the time of transmural stent placement results in earlier resolution of complex walled-off pancreatic necrosis: Results from a large multicenter United States trial. Endosc Ultrasound. 2019 May-Jun;8(3):172-179. doi: 10.4103/eus.eus_108_17.

  PMID: 29882517 BACKGROUND

• Schmidt PN, Novovic S, Roug S, Feldager E. Endoscopic, transmural drainage and necrosectomy for walled-off pancreatic and peripancreatic necrosis is associated with low mortality--a single-center experience. Scand J Gastroenterol. 2015 May;50(5):611-8. doi: 10.3109/00365521.2014.946078. Epub 2015 Feb 3.

  PMID: 25648776 BACKGROUND

• Bang JY, Navaneethan U, Hasan MK, Sutton B, Hawes R, Varadarajulu S. Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial. Gut. 2019 Jul;68(7):1200-1209. doi: 10.1136/gutjnl-2017-315335. Epub 2018 Jun 1.

  PMID: 29858393 BACKGROUND

• Kovacevic B, Vilmann P, Karstensen JG. Endoscopic Ultrasonography-Guided Gastrojejunostomies With Lumen-Apposing Metal Stents. Clin Gastroenterol Hepatol. 2017 Mar;15(3):459-460. doi: 10.1016/j.cgh.2016.09.144. Epub 2016 Sep 28. No abstract available.

  PMID: 27693524 BACKGROUND

• Karstensen JG, Novovic S, Hansen EF, Jensen AB, Jorgensen HL, Lauritsen ML, Werge MP, Schmidt PN. EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial. Gut. 2023 Jun;72(6):1167-1173. doi: 10.1136/gutjnl-2022-328225. Epub 2022 Nov 29.

  PMID: 36446550 DERIVED

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: A single-center, open-label, randomized, superiority trial

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 15, 2019
• Study Start: August 29, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-08

Locations

DK (1)