Health TrialsbyHealthPanel

WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts

ConditionsPancreatic Fluid CollectionPancreatitisPancreatic Pseudocyst
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTokyo University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Plastic stent

    Procedure/Surgery

    EUS-guided drainage will be conducted under endosonographic and fluoroscopic guidance within 72 hours of the randomisation. A linear echoendoscope will be advanced to the stomach or duodenum with moderate sedation, and the targeted pseudocyst will be visualised and punctured under endosonographic guidance. In cases with an insufficient improvement in inflammatory indicators (i.e., body temperature, white blood cell count, and C-reactive protein), the investigators will perform additional interventions including the addition of or replacement with a plastic stent or LAMS and/or percutaneous drainage if needed. In the plastic stent group, two (at least one) 7-Fr double pigtail stents will be placed. Following EUS-guided puncture of a pseudocyst, a guidewire will be coiled within the lesion, and another guidewire will be inserted alongside the prepositioned guidewire. The puncture tract will be dilated if needed.

  • LAMS

    Procedure/Surgery

    EUS-guided drainage will be conducted under endosonographic and fluoroscopic guidance within 72 hours of the randomisation. A linear echoendoscope will be advanced to the stomach or duodenum with moderate sedation, and the targeted pseudocyst will be visualised and punctured under endosonographic guidance. In cases with an insufficient improvement in inflammatory indicators (i.e., body temperature, white blood cell count, and C-reactive protein), the investigators will perform additional interventions including the addition of or replacement with a plastic stent or LAMS and/or percutaneous drainage if needed. In the LAMS group, a LAMS with electrocautery enhanced delivery will be placed (Hot AXIOS; Boston Scientific Japan, Tokyo, Japan). A guidewire or dilator will be used if needed.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Plastic stent groupExperimental treatment 1 intervention
Group B: LAMS groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical success within 180 days of randomisation

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.

Time frame
Six months

Secondary outcomes

1

Number of participants with treatment-related adverse events

The adverse events are defined and graded by the ASGE lexicon guideline.

Time frame
Five years
2

Mortality

Mortality from any cause

Time frame
Five years
3

Technical success of the initial EUS-guided drainage

Technical success is defined as the successful placement of any stent in the targeted pseudocyst during the initial EUS-guided drainage.

Time frame
One day
4

Time to clinical success

Time from randomization to clinical success

Time frame
Six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tokyo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: