WONDER-02: Plastic Stent vs. Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Fluid Collection
- Sponsor
- Tokyo University
- Enrollment
- 80
- Locations
- 26
- Primary Endpoint
- Clinical success within 180 days of randomisation
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
Pancreatic fluid collections (PFCs) develop as local complications of acute pancreatitis after four weeks of the disease onset. Pancreatic pseudocysts are a type of PFC, which is characterised by encapsulated non-necrotic contents. Pseudocysts occasionally become symptomatic (e.g., infection, GI symptoms), and given the high morbidity and mortality, it is mandatory to manage symptomatic pseudocysts appropriately to improve clinical outcomes of patients with acute pancreatitis overall. EUS-guided transluminal drainage has become a first-choice treatment option for symptomatic PFCs. In the setting of EUS-guided treatment of walled-off necrosis (WON, the other type of PFC), the potential benefits of LAMSs have been reported. Compared to plastic stents, LAMSs can serve as a transluminal port and thereby, facilitate the treatment of WON that often requires a long treatment duration with repeated interventions including direct endoscopic necrosectomy. With the increasing popularity and availability of LAMSs in interventional EUS overall, several retrospective studies have reported the feasibility of LAMS use for EUS-guided drainage of pancreatic pseudocysts. While a LAMS may enhance the drainage efficiency of pseudocysts due to its large calibre, the benefits of this stent may be mitigated in pseudocysts that, by definition, contain non-necrotic liquid contents and can be managed without necrosectomy. Indeed, several retrospective comparative studies failed to demonstrate the superiority of plastic stents to a LAMS. In addition, the use of a LAMS has been limited by higher costs compared to plastic stents and potential specific adverse events (e.g., bleeding, buried stent). Studies suggest that a prolonged duration of LAMS placement (approximately ≥ 4 weeks) may predispose the patients to an elevated risk of adverse events associated with LAMSs. Therefore, patients requiring long-term drainage (e.g., cases with disconnected pancreatic duct syndrome) should be subjected to a reintervention in which a LAMS is replaced by a plastic stent. However, the technical success rate of the replacement has not been high. Given these lines of evidence, the investigators hypothesised that plastic stents might be non-inferior to a LAMS in terms of the potential of resolving a pseudocyst and associated symptoms. To test the hypothesis, the investigators have planned a multicentre randomised controlled trial (RCT) to examine the non-inferiority of plastic stents to a LAMS as the initial stent for EUS-guided drainage of pancreatic pseudocysts in terms of the achievement of clinical treatment success (the resolution of a pseudocyst). Given the lower costs of plastic stents compared to a LAMS, the results would help not only establish a new treatment paradigm for pancreatic pseudocysts but also improve the cost-effectiveness of the resource-intensive treatment.
Investigators
Yousuke Nakai
Associate professor, Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital
Tokyo University
Eligibility Criteria
Inclusion Criteria
- •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
- •Written informed consent obtained from patients or their representatives
Exclusion Criteria
- •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
- •Patients who do not tolerate endoscopic procedures
- •Pregnant women
Outcomes
Primary Outcomes
Clinical success within 180 days of randomisation
Time Frame: Six months
Clinical success is defined as 1) a decrease in the size of a targeted pancreatic pseudocyst to 2 cm or less and 2) an improvement of at least two out of the following inflammatory indicators: body temperature, white blood cell count, and C-reactive protein.
Secondary Outcomes
- Costs of the index hospitalisation(Six months)
- Incidence of biliary stricture(Five years)
- Time requiring endoscopic drainage(Six months)
- Time requiring percutaneous drainage(Six months)
- Length of ICU stay during the index hospitalisation(Six months)
- Costs of interventions(Six months)
- Time to clinical success(Six months)
- Incidence of pseudocyst recurrence(Five years)
- Duration of antibiotics administration(Six months)
- Mortality(Five years)
- Technical success of the initial EUS-guided drainage(One day)
- Number of interventions(Six months)
- Time of interventions(Six months)
- Number of participants with treatment-related adverse events(Five years)
- Incidence of gastrointestinal stricture(Five years)
- Length of the index hospitalisation(Six months)
- Time to recurrence of pancreatic pseudocyst(Five years)
- Treatment duration of new onset pancreatic pseudocyst(Five years)
- Incidence of new onset diabetes(Five years)
- The presence of sarcopenia(Five years)
- Incidence of new onset clinical symptoms of pancreatic exocrine insufficiency(Five years)
- Treatment duration of recurrent pancreatic pseudocyst(Five years)
- New onset of pancreatic pseudocyst(Five years)
- Success rate of surgical procedures(Six months)
- Incidence of new pancreatic cancer(Five years)
- The presence of medications for pancreatic exocrine insufficiency(Five years)
- Change in volume of pancreas(Five years)
- Operation time of surgical procedures(Six months)