Trial Title:
WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts
NCT ID:
NCT06133023
Condition:
Pancreatic Fluid Collection
Pancreatitis
Pancreatic Pseudocyst
Conditions: Official terms:
Pancreatic Pseudocyst
Pancreatitis
Conditions: Keywords:
Endosonography
Drainage
Stents
Pancreatic Pseudocyst
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Plastic stent
Description:
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.
Arm group label:
Plastic stent group
Intervention type:
Procedure
Intervention name:
LAMS
Description:
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.
Arm group label:
LAMS group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Gastroenterology, Aichi Medical University
Address:
City:
Aichi
Country:
Japan
Contact:
Last name:
Tadahisa Inoue
Facility:
Name:
Department of Gastroenterology, The University of Tokyo Hospital
Address:
City:
Bunkyō-Ku, Tokyo
Zip:
113-8655
Country:
Japan
Contact:
Last name:
Yousuke Nakai
Contact backup:
Last name:
Tomotaka Saito
Phone:
+81-3-3815-5411
Email:
tomsaito-gi@umin.ac.jp
Facility:
Name:
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Address:
City:
Bunkyō-Ku, Tokyo
Country:
Japan
Contact:
Last name:
Hiroyuki Isayama
Contact backup:
Last name:
Toshio Fujisawa
Investigator:
Last name:
Sho Takahashi
Email:
Sub-Investigator
Facility:
Name:
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Address:
City:
Chiba
Country:
Japan
Contact:
Last name:
Hiroshi Ohyama
Contact backup:
Last name:
Koji Takahashi
Facility:
Name:
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Address:
City:
Fukuoka
Country:
Japan
Contact:
Last name:
Nao Fujimori
Contact backup:
Last name:
Kazuhide Matsumoto
Facility:
Name:
Department of Gastroenterology, Gifu Municipal Hospital
Address:
City:
Gifu
Country:
Japan
Contact:
Last name:
Keisuke Iwata
Contact backup:
Last name:
Mitsuru Okuno
Facility:
Name:
Department of Gastroenterology, Gifu Prefectural General Medical Center
Address:
City:
Gifu
Country:
Japan
Contact:
Last name:
Akinori Maruta
Contact backup:
Last name:
Kensaku Yoshida
Facility:
Name:
First Department of Internal Medicine, Gifu University Hospital
Address:
City:
Gifu
Country:
Japan
Contact:
Last name:
Takuji Iwashita
Contact backup:
Last name:
Shinya Uemura
Facility:
Name:
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University
Address:
City:
Hyōgo
Country:
Japan
Contact:
Last name:
Hideyuki Shiomi
Contact backup:
Last name:
Ryota Nakano
Facility:
Name:
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Address:
City:
Kagawa
Country:
Japan
Contact:
Last name:
Hideki Kamada
Contact backup:
Last name:
Ryota Nakabayashi
Facility:
Name:
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
Address:
City:
Kagoshima
Country:
Japan
Contact:
Last name:
Shinichi Hashimoto
Contact backup:
Last name:
Makoto Hinokuchi
Facility:
Name:
Department of Gastroenterology, Kameda Medical Center
Address:
City:
Kamogawa
Country:
Japan
Contact:
Last name:
Toshiyasu Shiratori
Contact backup:
Last name:
So Nakaji
Facility:
Name:
Department of Gastroenterology, St. Marianna University School of Medicine
Address:
City:
Kanagawa
Country:
Japan
Contact:
Last name:
Kazunari Nakahara
Contact backup:
Last name:
Yusuke Satta
Facility:
Name:
Department of Gastroenterological Endoscopy, Kanazawa Medical University
Address:
City:
Kanazawa
Country:
Japan
Contact:
Last name:
Tsuyoshi Mukai
Facility:
Name:
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Address:
City:
Kawagoe
Country:
Japan
Contact:
Last name:
Saburo Matsubara
Contact backup:
Last name:
Kentaro Suda
Facility:
Name:
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Address:
City:
Kawasaki
Country:
Japan
Contact:
Last name:
Shinpei Doi
Contact backup:
Last name:
Nobuhiro Katsukura
Facility:
Name:
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Address:
City:
Kobe
Country:
Japan
Contact:
Last name:
Atsuhiro Masuda
Contact backup:
Last name:
Arata Sakai
Investigator:
Last name:
Masahiro Tsujimae
Email:
Sub-Investigator
Facility:
Name:
Department of Gastroenterology and Hepatology, Mie University Hospital
Address:
City:
Mie
Country:
Japan
Contact:
Last name:
Reiko Yamada
Contact backup:
Last name:
Kenji Nose
Facility:
Name:
Department of Gastroenterology and Hepatology, Okayama University Hospital
Address:
City:
Okayama
Country:
Japan
Contact:
Last name:
Hironari Kato
Contact backup:
Last name:
Kazuyuki Matsumoto
Investigator:
Last name:
Ryosuke Sato
Email:
Sub-Investigator
Facility:
Name:
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University
Address:
City:
Osaka
Country:
Japan
Contact:
Last name:
Takeshi Ogura
Contact backup:
Last name:
Saori Ueno
Facility:
Name:
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Address:
City:
Sapporo
Country:
Japan
Contact:
Last name:
Masaki Kuwatani
Contact backup:
Last name:
Ryou Sugiura
Facility:
Name:
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Address:
City:
Tokyo
Country:
Japan
Contact:
Last name:
Hirofumi Kogure
Contact backup:
Last name:
Kei Saito
Facility:
Name:
Third Department of Internal Medicine, University of Toyama
Address:
City:
Toyama
Country:
Japan
Contact:
Last name:
Ichiro Yasuda
Contact backup:
Last name:
Nobuhiko Hayashi
Facility:
Name:
Department of Gastroenterology, Wakayama Medical University School of Medicine
Address:
City:
Wakayama
Country:
Japan
Contact:
Last name:
Masayuki Kitano
Contact backup:
Last name:
Takashi Tamura
Facility:
Name:
Department of Gastroenterology, Yamanashi Prefectural Central Hospital
Address:
City:
Yamanashi
Country:
Japan
Contact:
Last name:
Sumio Hirose
Facility:
Name:
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Address:
City:
Ōsaka
Country:
Japan
Contact:
Last name:
Mamoru Takenaka
Contact backup:
Last name:
Shunsuke Omoto
Start date:
November 2023
Completion date:
September 2033
Lead sponsor:
Agency:
Tokyo University
Agency class:
Other
Source:
Tokyo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06133023
