Pancreatic Fluid CollectionNCT06133023
WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts
A study testing Plastic stent and LAMS in people with Pancreatic Fluid Collection and Pancreatitis, run by Tokyo University at 26 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fluid Collection, Pancreatitis, Pancreatic Pseudocyst
- What is being tested?
- Plastic stent and LAMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 26 sitesJapan
- Study dates
- Nov 2023to Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
Japan26 sites
Department of Gastroenterology, Aichi Medical University
Aichi
Tadahisa Inoue
Department of Gastroenterology, The University of Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8655
Yousuke Nakai
Tomotaka Saito, +81-3-3815-5411, tomsaito-gi@umin.ac.jp
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo
Hiroyuki Isayama
Toshio Fujisawa
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Chiba
Hiroshi Ohyama
Koji Takahashi
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
Fukuoka
Nao Fujimori
Kazuhide Matsumoto
Department of Gastroenterology, Gifu Municipal Hospital
Gifu
Keisuke Iwata
Mitsuru Okuno
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu
Akinori Maruta
Kensaku Yoshida
First Department of Internal Medicine, Gifu University Hospital
Gifu
Takuji Iwashita
Shinya Uemura
Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University
Hyōgo
Hideyuki Shiomi
Ryota Nakano
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Kagawa
Hideki Kamada
Ryota Nakabayashi
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
Kagoshima
Shinichi Hashimoto
Makoto Hinokuchi
Department of Gastroenterology, Kameda Medical Center
Kamogawa
Toshiyasu Shiratori
So Nakaji
Department of Gastroenterology, St. Marianna University School of Medicine
Kanagawa
Kazunari Nakahara
Yusuke Satta
Department of Gastroenterological Endoscopy, Kanazawa Medical University
Kanazawa
Tsuyoshi Mukai
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe
Saburo Matsubara
Kentaro Suda
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Kawasaki
Shinpei Doi
Nobuhiro Katsukura
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe
Atsuhiro Masuda
Arata Sakai
Department of Gastroenterology and Hepatology, Mie University Hospital
Mie
Reiko Yamada
Kenji Nose
Department of Gastroenterology and Hepatology, Okayama University Hospital
Okayama
Hironari Kato
Kazuyuki Matsumoto
2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University
Osaka
Takeshi Ogura
Saori Ueno
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Ōsaka
Mamoru Takenaka
Shunsuke Omoto
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Sapporo
Masaki Kuwatani
Ryou Sugiura
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Tokyo
Hirofumi Kogure
Kei Saito
Third Department of Internal Medicine, University of Toyama
Toyama
Ichiro Yasuda
Nobuhiko Hayashi
Department of Gastroenterology, Wakayama Medical University School of Medicine
Wakayama
Masayuki Kitano
Takashi Tamura
Department of Gastroenterology, Yamanashi Prefectural Central Hospital
Yamanashi
Sumio Hirose
About this study
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
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.
Read the 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.
- Being tested
- Plastic stent, LAMS
- Keywords
- Endosonography, Drainage, Stents, Pancreatic Pseudocyst
- Medical subject headings
- Pancreatitis, Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastic stentProcedure or 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.
LAMSProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Plastic stent group | Experimental | 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. Receives: Procedure: Plastic stent |
| LAMS group | Active comparator | 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. Receives: Procedure: LAMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (28)
Number of participants with treatment-related adverse events
The adverse events are defined and graded by the ASGE lexicon guideline.
Measured: Five years
Mortality
Mortality from any cause
Measured: Five years
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.
Measured: One day
Time to clinical success
Time from randomization to clinical success
Measured: Six months
Incidence of biliary stricture
Biliary stricture due to a pseudocyst
Measured: Five years
Incidence of gastrointestinal stricture
Gastrointestinal obstruction due to a pseudocyst
Measured: Five years
Time requiring endoscopic drainage
Time requiring endoscopic drainage for a pseudocyst
Measured: Six months
Time requiring percutaneous drainage
Time requiring percutaneous drainage for a pseudocyst
Measured: Six months
Number of interventions
Total number of interventions needed for the treatment of a pseudocyst
Measured: Six months
Time of interventions
Total procedure time needed for the treatment of a pseudocyst
Measured: Six months
Length of the index hospitalisation
Total days of the index hospitalisation
Measured: Six months
Length of ICU stay during the index hospitalisation
Total ICU stay of the index hospitalisation
Measured: Six months
Duration of antibiotics administration
Total administration days of antibiotics
Measured: Six months
Costs of interventions
Total costs of treatment interventions
Measured: Six months
Costs of the index hospitalisation
Total costs of the index hospitalisation
Measured: Six months
Incidence of pseudocyst recurrence
Incidence of pseudocyst recurrence after clinical success
Measured: Five years
Time to recurrence of pancreatic pseudocyst
Time from clinical success to recurrence of pancreatic pseudocyst
Measured: Five years
Treatment duration of recurrent pancreatic pseudocyst
Total treatment days for recurrent pancreatic pseudocyst
Measured: Five years
New onset of pancreatic pseudocyst
Incidence of new-onset pancreatic pseudocyst
Measured: Five years
Treatment duration of new onset pancreatic pseudocyst
Total treatment days for new-onset pancreatic pseudocyst
Measured: Five years
Incidence of new onset diabetes
Incidence of new-onset diabetes mellitus
Measured: Five years
The presence of medications for pancreatic exocrine insufficiency
The start of medications for pancreatic exocrine insufficiency and the date
Measured: Five years
The presence of sarcopenia
The presence of sarcopenia and the date of diagnosis
Measured: Five years
Change in volume of pancreas
Change in volume of pancreas. Volume is evaluated by contrast-enhanced Computed Tomography (CT) using SYNAPSE VINCENT (FUJIFILM).
Measured: Five years
Success rate of surgical procedures
Success rate of surgeries associated with pancreatic pseudocyst
Measured: Six months
Operation time of surgical procedures
Total operation times
Measured: Six months
Incidence of new onset clinical symptoms of pancreatic exocrine insufficiency
New-onset clinical symptoms associated with pancreatic exocrine insufficiency, such as steatorrhea , constipation, diarrhea, maldigestion, flatulence, and tenesmus
Measured: Five years
Incidence of new pancreatic cancer
New-onset pancreatic cancer
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Fluid CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousuke Nakai, Tokyo University
- Investigators
- Yousuke Nakai, Principal investigator, Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133023
- Sponsor's protocol ID
- 2023002P
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Saito T, Takenaka M, Kuwatani M, Doi S, Ohyama H, Fujisawa T, Masuda A, Iwashita T, Shiomi H, Hayashi N, Iwata K, Maruta A, Mukai T, Matsubara S, Hamada T, Inoue T, Matsumoto K, Hirose S, Fujimori N, Kashiwabara K, Kamada H, Hashimoto S, Shiratori T, Yamada R, Kogure H, Nakahara K, Ogura T, Kitano M, Yasuda I, Isayama H, Nakai Y; WONDERFUL study group in Japan and collaborators. WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts-study protocol for a multicentre randomised non-inferiority trial. Trials. 2024 Aug 24;25(1):559. doi: 10.1186/s13063-024-08373-6.
PubMed 39182137
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06133023
- Acronym / sponsor ID
- 2023002P
- Keywords
- Endosonography, Drainage, Stents, Pancreatic Pseudocyst
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic stent group | Experimental | Procedure: Plastic stentIn 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 group | Active comparator | Procedure: LAMSIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plastic stentEUS-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. | Procedure or surgery | Plastic stent group |
| LAMSEUS-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. | Procedure or surgery | LAMS group |
Primary outcome
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.
28 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: Five years
Mortality
Time frame: Five years
Technical success of the initial EUS-guided drainage
Time frame: One day
Time to clinical success
Time frame: Six months
Incidence of biliary stricture
Time frame: Five years
Incidence of gastrointestinal stricture
Time frame: Five years
Time requiring endoscopic drainage
Time frame: Six months
Time requiring percutaneous drainage
Time frame: Six months
Number of interventions
Time frame: Six months
Time of interventions
Time frame: Six months
Length of the index hospitalisation
Time frame: Six months
Length of ICU stay during the index hospitalisation
Time frame: Six months
Duration of antibiotics administration
Time frame: Six months
Costs of interventions
Time frame: Six months
Costs of the index hospitalisation
Time frame: Six months
Incidence of pseudocyst recurrence
Time frame: Five years
Time to recurrence of pancreatic pseudocyst
Time frame: Five years
Treatment duration of recurrent pancreatic pseudocyst
Time frame: Five years
New onset of pancreatic pseudocyst
Time frame: Five years
Treatment duration of new onset pancreatic pseudocyst
Time frame: Five years
Incidence of new onset diabetes
Time frame: Five years
The presence of medications for pancreatic exocrine insufficiency
Time frame: Five years
The presence of sarcopenia
Time frame: Five years
Change in volume of pancreas
Time frame: Five years
Success rate of surgical procedures
Time frame: Six months
Operation time of surgical procedures
Time frame: Six months
Incidence of new onset clinical symptoms of pancreatic exocrine insufficiency
Time frame: Five years
Incidence of new pancreatic cancer
Time frame: Five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Derived from this study: PubMed 39182137Saito T, Takenaka M, Kuwatani M, Doi S, Ohyama H, Fujisawa T, Masuda A, Iwashita T, Shiomi H, Hayashi N, Iwata K, Maruta A, Mukai T, Matsubara S, Hamada T, Inoue T, Matsumoto K, Hirose S, Fujimori N, Kashiwabara K, Kamada H, Hashimoto S, Shiratori T, Yamada R, Kogure H, Nakahara K, Ogura T, Kitano M, Yasuda I, Isayama H, Nakai Y; WONDERFUL study group in Japan and collaborators. WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts-study protocol for a multicentre randomised non-inferiority trial. Trials. 2024 Aug 24;25(1):559. doi: 10.1186/s13063-024-08373-6.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Fluid Collection
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Not yet recruiting
Percutaneous Versus EUS-guided Drainage of Symptomatic Fluid Collections After Left Pancreatectomy
Symptomatic Fluid Collection(s)
RecruitingObservational study
Prospective Registry Of Therapeutic EndoscopiC ulTrasound
Gastric Outlet Obstruction, Biliary Obstruction
Active, not recruitingObservational study
Pancreatic Antibiotic Concentration Evaluation Assessment
Acute Pancreatic Fluid Collection, Acute Pancreatitis
Active, not recruitingObservational study
A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis
Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yousuke Nakai principal investigator
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plastic stent and LAMS in people with Pancreatic Fluid Collection and Pancreatitis, run by Tokyo University at 26 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yousuke Nakai (+81-3-3815-5411, ynakai-tky@umin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success within 180 days of randomisation (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133023, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.