Pancreatic Fluid CollectionWONDER-01NCT05451901
Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis
A study testing Immediate necrosectomy and Step-up approach in people with Pancreatic Fluid Collection and Walled-off Necrosis, run by Tokyo University at 21 sites in Japan.
Trial summary
Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Fluid Collection, Walled-off Necrosis, Pancreatitis, Acute Necrotizing
- What is being tested?
- Immediate necrosectomy and Step-up approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 21 sitesJapan
- Study dates
- 29 Jul 2022to 11 Apr 2031
- 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 WON defined according to the revised Atlanta classification
- The longest diameter of WON is 4 cm or larger
- Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
- Patients who need drainage for WON
- Age of 18 years or older
- Patients or their representatives provide informed consent
- Patients who visit or are hospitalized at the participating institutions
Who cannot join
- WON inaccessible by EUS-guided approach
- AXIOS stent has already been placed into the WON prior to the enrollment
- Severe coagulopathy; Platelet count < 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) >1.5
- Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)"
- Patients who cannot tolerate endoscopic procedures
- Pregnant women
- Patients considered inappropriate for inclusion by investigators
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Japan21 sites, 21 recruiting
- Recruiting
Department of Gastroenterology, Aichi Medical University
Aichi
Tadahisa Inoue
- Not yet recruiting
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
- Recruiting
Department of Gastroenterology, Graduate School of Medicine, Juntendo University
Bunkyō-Ku, Tokyo
Hiroyuki Isayama
Toshio Fujisawa
- Recruiting
Department of Gastroenterology, Graduate School of Medicine, Chiba University
Chiba
Hiroshi Ohyama
Koji Takahashi
- Recruiting
Department of Gastroenterology, Gifu Municipal Hospital
Gifu
Keisuke Iwata
Mitsuru Okuno
- Recruiting
Department of Gastroenterology, Gifu Prefectural General Medical Center
Gifu
Akinori Maruta
Kensaku Yoshida
- Not yet recruiting
First Department of Internal Medicine, Gifu University Hospital
Gifu
Takuji Iwashita
Shinya Uemura
- Recruiting
Division of Gastroenterology and Hepatobiliary and Pancreatic Diseases, Department of Internal Medicine, Hyogo Medical University
Hyōgo
Hideyuki Shiomi
Shogo Ota
- Recruiting
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Kagawa
Hideki Kamada
Daisuke Namima
- Recruiting
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences
Kagoshima
Shinichi Hashimoto
Makoto Hinokuchi
- Recruiting
Department of Gastroenterology, Kameda Medical Center
Kamogawa
Toshiyasu Shiratori
So Nakaji
- Not yet recruiting
Department of Gastroenterological Endoscopy, Kanazawa Medical University
Kanazawa
Tsuyoshi Mukai
- Not yet recruiting
Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University
Kawagoe
Saburo Matsubara
Keito Nakagawa
- Not yet recruiting
Department of Gastroenterology, Teikyo University Mizonokuchi Hospital
Kawasaki
Shinpei Doi
Nobuhiro Katsukura
- Recruiting
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Kobe
Atsuhiro Masuda
Masahiro Tsujimae
- Recruiting
Department of Gastroenterology, Yuuai Medical Center
Okinawa
Kenji Chinen
- Not yet recruiting
2nd Department of Internal Medicine, Osaka Medical College
Osaka
Takeshi Ogura
Atsushi Okuda
- Not yet recruiting
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine
Ōsaka-sayama
Mamoru Takenaka
Shunsuke Omoto
- Recruiting
Department of Gastroenterology and Hepatology, Hokkaido University Hospital
Sapporo
Masaki Kuwatani
- Not yet recruiting
Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine
Tokyo
Hirofumi Kogure
Kei Saito
- Recruiting
Third Department of Internal Medicine, University of Toyama
Toyama
Ichiro Yasuda
Nobuhiko Hayashi
About this study
Official title: Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
Read the detailed description
Pancreatic fluid collection is a late complication of severe acute pancreatitis. According to the revised Atlanta classification, walled-off necrosis (WON) is defined as an encapsulated collection of necrotic tissue that is observed after four weeks of the onset of acute pancreatitis. Infected WON is associated with high morbidity and mortality; therefore, an appropriate treatment, including antibiotics and drainage, is mandatory. With the development of endoscopic equipment, endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality for infected WON. For patients who are refractory to EUS-guided drainage, endoscopic necrosectomy (EN) is a treatment option to facilitate direct removal of infected necrotic tissue within the WON. However, due to potentially lethal adverse events of EN, such as bleeding, perforation, and peritonitis, EN is usually withheld for several days after EUS-guided drainage. This strategy is known as "the step-up approach." Recently, with the accumulated evidence supporting the safety of EN, especially with the use of a dedicated lumen-apposing metal stent, it has been reported that EN immediately after EUS-guided drainage can shorten the treatment duration without increasing adverse events. Given these lines of evidence, the investigators hypothesized that immediate EN following EUS-guided drainage of WON might shorten time to clinical success compared to the step-up approach. To examine this hypothesis, the investigators planned to conduct a multicenter randomized controlled trial comparing treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
- Conditions
- Pancreatic Fluid Collection, Walled-off Necrosis, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst
- Being tested
- Immediate necrosectomy, Step-up approach
- Keywords
- Endosonography, Drainage, Stents, Endoscopic necrosectomy, Step-up approach
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate necrosectomyProcedure or surgery
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage.
For the immediate necrosectomy group, endoscopic necrosectomy (EN) will be performed in the same session of EUS-guided drainage using a gastroscope. The endoscope is inserted into the WON cavity through the LAMS, and necrotic tissue is removed using biopsy forceps, snare, or basket catheter. The EN procedures will be repeated until clinical improvement.
Step-up approachProcedure or surgery
Endoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage.
For the step-up approach group, an additional interventional procedure will be withheld for 72-96 hours after initial EUS-guided drainage. In cases without clinical improvement after 72-96 hours, additional drainage will be permitted, which includes increasing the number of stents, additional EUS-guided drainage, and performing percutaneous drainage (step-up treatment). Insufficient improvement even after two times of step-up treatment allows subsequent endoscopic necrosectomy (EN).
| Study group | Role | What they receive |
|---|---|---|
| Immediate necrosectomy | Experimental | Endoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success. Receives: Procedure: Immediate necrosectomy |
| Step-up approach | Active comparator | Step-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment. Receives: Procedure: Step-up approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical success from randomization
Clinical success is defined as 1) a decrease in the WON size to 3 cm or less and 2) an improvement of more than two out of the three following inflammatory markers; body temperature, white blood cell count, and C-reactive protein.
Measured: Six months
Secondary outcomes (19)
Adverse events
All procedure-related adverse events including bleeding, perforation, peritonitis, etc.
Measured: Five years
Mortality
Mortality from any cause
Measured: Five years
Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage)
Successful placement of EUS-guided drainage including a lumen-apposing metal stent and plastic stents
Measured: One day
Incidence of biliary and gastrointestinal stricture
Inflammatory-induced obstruction of bile duct and gastrointestinal tract
Measured: Five years
Number and time of interventions
Total number of interventions and total procedure time
Measured: Six months
Indwelling time of endoscopic and percutaneous drainage
Indwelling period of stents and drainage tube
Measured: Six months
Success rate and operation time of surgical procedures
Success rate of surgeries associated with WON and total operation time
Measured: Six months
Hospital stay and ICU stay
Total hospitalization days and total ICU stay
Measured: Six months
Duration of antibiotics administration
Total administration days of antibiotics
Measured: Six months
Cost of interventions and hospital stay
Total cost of interventions and total cost of hospitalization
Measured: Six months
Recurrence of WON
Incidence of recurrence of WON
Measured: Five years
Time to recurrence of WON
Time from clinical success to recurrence of WON
Measured: Five years
Treatment duration of recurrent WON
Total treatment period for recurrent WON
Measured: Five years
New onset of pseudocyst
Incidence of new-onset pancreatic pseudocyst
Measured: Five years
Treatment duration of new onset pseudocyst
Total treatment period for new-onset pancreatic pseudocyst
Measured: Five years
Incidence of new onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer
New-onset diabetes mellitus, pancreatic cancer, and clinical symptoms associated with pancreatic exocrine insufficiency, such as steatorrhea , constipation, diarrhea, maldigestion, flatulence, and tenesmus
Measured: Five years
The presence and timing of medications for pancreatic exocrine insufficiency
The start of medications for pancreatic exocrine insufficiency and the date
Measured: Five years
The presence and timing of sarcopenia
The presence of sarcopenia and the date of diagnosis
Measured: Five years
Morphological change of pancreas
Change in the morphology and the volume of pancreas
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 posted11 Jul 2022
- Study start29 Jul 2022
- Primary completion1 Apr 2025 (estimated)
- Study completion11 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 70 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
- NCT05451901
- Sponsor's protocol ID
- 2021005P
- Other IDs
- jRCT1032220055
- Acronym
- WONDER-01
- Status last verified
- Oct 2022
- First submitted
- 3 Jul 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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, Fujisawa T, Ogura T, Kuwatani M, Ohyama H, Takenaka M, Doi S, Iwata K, Hashimoto S, Kamada H, Iwashita T, Shiomi H, Masuda A, Matsubara S, Hayashi N, Maruta A, Kogure H, Inoue T, Yamada R, Shiratori T, Hamada T, Ueno S, Okuda A, Takahashi S, Sugiura R, Kawakubo K, Takahashi K, Kan M, Omoto S, Yamazaki T, Katsukura N, Okuno M, Hinokuchi M, Namima D, Uemura S, Nakano R, Sakai A, Suda K, Yoshida K, Saito K, Kitano R, Nose K, Nakaji S, Mukai T, Nakahara K, Chinen K, Isayama H, Yasuda I, Nakai Y; WONDERFUL study group in Japan and collaborators. Immediate or On-Demand Endoscopic Necrosectomy for Necrotizing Pancreatitis: A Randomized Controlled Trial (WONDER-01). Gastroenterology. 2026 Jul;171(1):140-153. doi: 10.1053/j.gastro.2026.01.034. Epub 2026 Feb 18.
PubMed 41720198Sato T, Saito T, Takenaka M, Iwashita T, Shiomi H, Fujisawa T, Hayashi N, Iwata K, Maruta A, Mukai T, Masuda A, Matsubara S, Hamada T, Inoue T, Ohyama H, Kuwatani M, Kamada H, Hashimoto S, Shiratori T, Yamada R, Kogure H, Ogura T, Nakahara K, Doi S, Chinen K, Isayama H, Yasuda I, Nakai Y; WONDERFUL study group in Japan, collaborators. WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis-study protocol for a multicentre randomised controlled trial. Trials. 2023 May 24;24(1):352. doi: 10.1186/s13063-023-07377-y.
PubMed 37226252
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
- ClinicalTrials.gov ID
- NCT05451901
- Acronym / sponsor ID
- WONDER-01 / 2021005P
- Conditions
- Pancreatic Fluid Collection, Walled-off Necrosis, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst
- Keywords
- Endosonography, Drainage, Stents, Endoscopic necrosectomy, Step-up approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tokyo UniversityUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 11 Apr 2031 (estimated)
- First posted
- 11 Jul 2022 (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.
Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
Detailed description
Pancreatic fluid collection is a late complication of severe acute pancreatitis. According to the revised Atlanta classification, walled-off necrosis (WON) is defined as an encapsulated collection of necrotic tissue that is observed after four weeks of the onset of acute pancreatitis. Infected WON is associated with high morbidity and mortality; therefore, an appropriate treatment, including antibiotics and drainage, is mandatory. With the development of endoscopic equipment, endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality for infected WON. For patients who are refractory to EUS-guided drainage, endoscopic necrosectomy (EN) is a treatment option to facilitate direct removal of infected necrotic tissue within the WON. However, due to potentially lethal adverse events of EN, such as bleeding, perforation, and peritonitis, EN is usually withheld for several days after EUS-guided drainage. This strategy is known as "the step-up approach." Recently, with the accumulated evidence supporting the safety of EN, especially with the use of a dedicated lumen-apposing metal stent, it has been reported that EN immediately after EUS-guided drainage can shorten the treatment duration without increasing adverse events. Given these lines of evidence, the investigators hypothesized that immediate EN following EUS-guided drainage of WON might shorten time to clinical success compared to the step-up approach. To examine this hypothesis, the investigators planned to conduct a multicenter randomized controlled trial comparing treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate necrosectomy | Experimental | Procedure: Immediate necrosectomyEndoscopic necrosectomy will be conducted in the same session of EUS-guided drainage (or at least within 72 hours of randomization) and be repeated until clinical success. |
| Step-up approach | Active comparator | Procedure: Step-up approachStep-up treatment will be conducted if a patient's condition does not improve after EUS-guided drainage. The step-up approach includes increasing the number of stents, adding another EUS-guided drainage, and performing percutaneous drainage after 72-96 hours of the initial drainage. Endoscopic necrosectomy is considered when clinical improvement is not observed even after two times of step-up treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with WON defined according to the revised Atlanta classification
- The longest diameter of WON is 4 cm or larger
- Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
- Patients who need drainage for WON
- Age of 18 years or older
Key exclusion criteria (7 listed)
- WON inaccessible by EUS-guided approach
- AXIOS stent has already been placed into the WON prior to the enrollment
- Severe coagulopathy; Platelet count < 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) >1.5
- Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)"
- Patients who cannot 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 |
|---|---|---|
| Immediate necrosectomyEndoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the immediate necrosectomy group, endoscopic necrosectomy (EN) will be performed in the same session of EUS-guided drainage using a gastroscope. The endoscope is inserted into the WON cavity through the LAMS, and necrotic tissue is removed using biopsy forceps, snare, or basket catheter. The EN procedures will be repeated until clinical improvement. | Procedure or surgery | Immediate necrosectomy |
| Step-up approachEndoscopic ultrasonography (EUS)-guided drainage will be conducted within 72 hours from randomization. A convex-type echoendoscope is advanced to the stomach or duodenum, and the walled-off necrosis (WON) is visualized and punctured under EUS guidance. A lumen-apposing metal stent (LAMS), such as Hot AXIOS system (Boston Scientific Japan, Tokyo, Japan), is recommended for the initial EUS-guided drainage. For the step-up approach group, an additional interventional procedure will be withheld for 72-96 hours after initial EUS-guided drainage. In cases without clinical improvement after 72-96 hours, additional drainage will be permitted, which includes increasing the number of stents, additional EUS-guided drainage, and performing percutaneous drainage (step-up treatment). Insufficient improvement even after two times of step-up treatment allows subsequent endoscopic necrosectomy (EN). | Procedure or surgery | Step-up approach |
Primary outcome
Time to clinical success from randomization
Time frame: Six months
Clinical success is defined as 1) a decrease in the WON size to 3 cm or less and 2) an improvement of more than two out of the three following inflammatory markers; body temperature, white blood cell count, and C-reactive protein.
19 secondary outcomes
Adverse events
Time frame: Five years
Mortality
Time frame: Five years
Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage)
Time frame: One day
Incidence of biliary and gastrointestinal stricture
Time frame: Five years
Number and time of interventions
Time frame: Six months
Indwelling time of endoscopic and percutaneous drainage
Time frame: Six months
Success rate and operation time of surgical procedures
Time frame: Six months
Hospital stay and ICU stay
Time frame: Six months
Duration of antibiotics administration
Time frame: Six months
Cost of interventions and hospital stay
Time frame: Six months
Recurrence of WON
Time frame: Five years
Time to recurrence of WON
Time frame: Five years
Treatment duration of recurrent WON
Time frame: Five years
New onset of pseudocyst
Time frame: Five years
Treatment duration of new onset pseudocyst
Time frame: Five years
Incidence of new onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer
Time frame: Five years
The presence and timing of medications for pancreatic exocrine insufficiency
Time frame: Five years
The presence and timing of sarcopenia
Time frame: Five years
Morphological change of pancreas
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 27 Oct 2022.
- 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 41720198Saito T, Fujisawa T, Ogura T, Kuwatani M, Ohyama H, Takenaka M, Doi S, Iwata K, Hashimoto S, Kamada H, Iwashita T, Shiomi H, Masuda A, Matsubara S, Hayashi N, Maruta A, Kogure H, Inoue T, Yamada R, Shiratori T, Hamada T, Ueno S, Okuda A, Takahashi S, Sugiura R, Kawakubo K, Takahashi K, Kan M, Omoto S, Yamazaki T, Katsukura N, Okuno M, Hinokuchi M, Namima D, Uemura S, Nakano R, Sakai A, Suda K, Yoshida K, Saito K, Kitano R, Nose K, Nakaji S, Mukai T, Nakahara K, Chinen K, Isayama H, Yasuda I, Nakai Y; WONDERFUL study group in Japan and collaborators. Immediate or On-Demand Endoscopic Necrosectomy for Necrotizing Pancreatitis: A Randomized Controlled Trial (WONDER-01). Gastroenterology. 2026 Jul;171(1):140-153. doi: 10.1053/j.gastro.2026.01.034. Epub 2026 Feb 18.
- Derived from this study: PubMed 37226252Sato T, Saito T, Takenaka M, Iwashita T, Shiomi H, Fujisawa T, Hayashi N, Iwata K, Maruta A, Mukai T, Masuda A, Matsubara S, Hamada T, Inoue T, Ohyama H, Kuwatani M, Kamada H, Hashimoto S, Shiratori T, Yamada R, Kogure H, Ogura T, Nakahara K, Doi S, Chinen K, Isayama H, Yasuda I, Nakai Y; WONDERFUL study group in Japan, collaborators. WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis-study protocol for a multicentre randomised controlled trial. Trials. 2023 May 24;24(1):352. doi: 10.1186/s13063-023-07377-y.
- Individual participant dataSharing planned: No
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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
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate necrosectomy and Step-up approach in people with Pancreatic Fluid Collection and Walled-off Necrosis, run by Tokyo University at 21 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Time to clinical success from randomization (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 NCT05451901, which also lists 3 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 27 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.