Skip to main content
OpenTrials
Completed

NCT Number: NCT04057846

Lumen Apposing Metal Stents vs Double Pigtail Stents

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatitis,Acute Necrotizing Digestive System Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital Hvidovre

Hvidovre, Capital, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

(all criteria must be fulfilled):

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Number of necrosectomies

    Time frame: Through study completion, an average of 2 year

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

Secondary outcomes

  1. Number of endoscopic procedures

    Time frame: Through study completion, an average of 6 months

    Number of endoscopic procedures (drainage (including redilatation) and debridement)

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

    Time frame: Through study completion, an average of 6 months

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

    Time frame: Through study completion, an average of 6 months

  4. Duration of drainage and debridement procedures

    Time frame: Through study completion, an average of 6 months

    Duration of drainage and debridement procedures (index and cumulated). It will be in minutes

  5. Length of hospital stay from the index drainage procedure

    Time frame: Through study completion, an average of 6 months

    Days of hospital stay from the index drainage procedure

  6. Length of ICU stay

    Time frame: Through study completion, an average of 6 months

    Days in the ICU

  7. Resolution of pre-interventional systemic inflammatory response syndrome (SIRS) (sepsis)

    Time frame: Through study completion, an average of 6 months

    Restoration of normal blood pressure, temperature, heart rate, inspiratory rate, and white blod cell count

  8. New onset episodes of culture verified bacteremia

    Time frame: Through study completion, an average of 6 months

  9. Occurrence of splanchnic vein thrombosis (portal-, splenic-, or superior mesenteric vein)

    Time frame: Through study completion, an average of 6 months

  10. Need for tube feeding (naso-gastric or naso-jejunal) or parenteral nutrition

    Time frame: Through study completion, an average of 6 months

  11. CRP-area under curve (AUC) from the index drainage procedure until discharge from hospital

    Time frame: Though the hospital stay, an average of 6 months

  12. Number of adverse events according to the ASGE lexicon and Clavien-Dindo.

    Time frame: Though the hospital stay, an average of 6 months

    Specific adverse events and grouped by severity

  13. Mortality

    Time frame: Though the hospital stay, an average of 6 months

    The rate mortality compared between the two study groups

  14. Exocrine and endocrine insufficiency

    Time frame: Though the hospital stay, an average of 6 months

    The unset of diabetes and Steatorré

  15. Total treatment costs.

    Time frame: Through study completion

    In euros and dollars

Sponsors and collaborators

Lead sponsor

John Gasdal Karstensen

Other

Registry information

Official study title

EUS-guided Drainage of Large Walled-off Pancreatic Necrosis Using Lumen Apposing Metal Stents or Standard Double Pigtail Technique. A Single-center, Open-label, Randomized, Superiority Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2019
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.