Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133023
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-10-29
Brief Title:
WONDER-02 Trial Plastic Stent vs Lumen-apposing Metal Stent for Pancreatic Pseudocysts
Sponsor:
Tokyo University
Organization:
Tokyo University
Study Overview
Official Title:
WONDER-02 Plastic Stent vs Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 eg 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 eg 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
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 eg 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None