Health Trials

About this trial

Endoscopic ultrasound (EUS)-guided transluminal drainage has become a first-line treatment modality for symptomatic pancreatic pseudocysts. Despite the increasing popularity of lumen-apposing metal stents (LAMSs), the use of a LAMS is limited by its high costs and specific adverse events compared to plastic stent placement. To date, there has been a paucity of data on the appropriate stent type in this setting. This trial aims to assess the non-inferiority of plastic stents to a LAMS for the initial EUS-guided drainage of pseudocysts.

Eligibility criteria

Qualifiers

Patients with pancreatic pseudocyst(s) defined by the revised Atlanta classification

The longest diameter of a targeted pseudocyst ≥ 5 cm

Patients requiring drainage for symptoms associated with a pseudocyst (e.g., infection, gastrointestinal symptoms including abdominal pain, or jaundice)

Patients aged 18 years or older

Disqualifiers

A pseudocyst that is inaccessible via the EUS-guided approach

A plastic or lumen-apposing metal stent in situ

Coagulopathy (e.g., platelet count < 50,000/mm3 or prothrombin time international normalised ratio [PT-INR] >1.5)

Users of antithrombotic agents that cannot be discontinued according to the Japan Gastroenterological Endoscopy Society [JGES] guidelines

Trial design

Treatments tested in this trial

  • Plastic stent
  • LAMS

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

26
Department of Gastroenterology, Aichi Medical University Aichi Japan
Department of Gastroenterology, Graduate School of Medicine, Juntendo University Bunkyō-Ku, Tokyo Japan
Department of Gastroenterology, The University of Tokyo Hospital113-8655, Bunkyō-Ku, Tokyo Japan
Department of Gastroenterology, Graduate School of Medicine, Chiba University Chiba Japan

Sponsors and collaborators

Tokyo University

Lead sponsor

Source ClinicalTrials.gov