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

NCT ID: NCT06133023

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2033-09-30

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 (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.

Conditions

Pancreatic Fluid Collection; Pancreatitis; Pancreatic Pseudocyst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plastic stent group

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.

Group Type: EXPERIMENTAL

Plastic stent

Intervention Type: PROCEDURE

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 group

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.

Group Type: ACTIVE_COMPARATOR

LAMS

Intervention Type: PROCEDURE

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.

Interventions

Plastic stent

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.

Intervention Type: PROCEDURE

LAMS

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo University

OTHER

Sponsor Role: lead

Responsible Party

Yousuke Nakai

Associate professor, Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yousuke Nakai

Role: PRINCIPAL_INVESTIGATOR

Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo

Locations

Department of Gastroenterology, Aichi Medical University

Aichi, , Japan

Department of Gastroenterology, The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, , Japan

Department of Gastroenterology, Graduate School of Medicine, Juntendo University

Bunkyō-Ku, Tokyo, , Japan

Department of Gastroenterology, Graduate School of Medicine, Chiba University

Chiba, , Japan

Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University

Fukuoka, , Japan

Department of Gastroenterology, Gifu Municipal Hospital

Gifu, , Japan

Department of Gastroenterology, Gifu Prefectural General Medical Center

Gifu, , Japan

First Department of Internal Medicine, Gifu University Hospital

Gifu, , Japan

Division of Hepatobiliary and Pancreatic Diseases, Department of Gastroenterology, Hyogo Medical University

Hyōgo, , Japan

Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University

Kagawa, , Japan

Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences

Kagoshima, , Japan

Department of Gastroenterology, Kameda Medical Center

Kamogawa, , Japan

Department of Gastroenterology, St. Marianna University School of Medicine

Kanagawa, , Japan

Department of Gastroenterological Endoscopy, Kanazawa Medical University

Kanazawa, , Japan

Department of Gastroenterology and Hepatology, Saitama Medical Center, Saitama Medical University

Kawagoe, , Japan

Department of Gastroenterology, Teikyo University Mizonokuchi Hospital

Kawasaki, , Japan

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

Kobe, , Japan

Department of Gastroenterology and Hepatology, Mie University Hospital

Mie, , Japan

Department of Gastroenterology and Hepatology, Okayama University Hospital

Okayama, , Japan

2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University

Osaka, , Japan

Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine

Ōsaka, , Japan

Department of Gastroenterology and Hepatology, Hokkaido University Hospital

Sapporo, , Japan

Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine

Tokyo, , Japan

Third Department of Internal Medicine, University of Toyama

Toyama, , Japan

Department of Gastroenterology, Wakayama Medical University School of Medicine

Wakayama, , Japan

Department of Gastroenterology, Yamanashi Prefectural Central Hospital

Yamanashi, , Japan

Countries

Japan

Central Contacts

Yousuke Nakai

Role: CONTACT

ynakai-tky@umin.ac.jp

+81-3-3815-5411

Tomotaka Saito

Role: CONTACT

tomsaito-gi@umin.ac.jp

+81-3-3815-5411

Facility Contacts

Tadahisa Inoue

Role: primary

Yousuke Nakai

Role: primary

Tomotaka Saito

Role: backup

tomsaito-gi@umin.ac.jp

+81-3-3815-5411

Hiroyuki Isayama

Role: primary

Toshio Fujisawa

Role: backup

Hiroshi Ohyama

Role: primary

Koji Takahashi

Role: backup

Nao Fujimori

Role: primary

Kazuhide Matsumoto

Role: backup

Keisuke Iwata

Role: primary

Mitsuru Okuno

Role: backup

Akinori Maruta

Role: primary

Kensaku Yoshida

Role: backup

Takuji Iwashita

Role: primary

Shinya Uemura

Role: backup

Hideyuki Shiomi

Role: primary

Ryota Nakano

Role: backup

Hideki Kamada

Role: primary

Ryota Nakabayashi

Role: backup

Shinichi Hashimoto

Role: primary

Makoto Hinokuchi

Role: backup

Toshiyasu Shiratori

Role: primary

So Nakaji

Role: backup

Kazunari Nakahara

Role: primary

Yusuke Satta

Role: backup

Tsuyoshi Mukai

Role: primary

Saburo Matsubara

Role: primary

Kentaro Suda

Role: backup

Shinpei Doi

Role: primary

Nobuhiro Katsukura

Role: backup

Atsuhiro Masuda

Role: primary

Arata Sakai

Role: backup

Reiko Yamada

Role: primary

Kenji Nose

Role: backup

Hironari Kato

Role: primary

Kazuyuki Matsumoto

Role: backup

Takeshi Ogura

Role: primary

Saori Ueno

Role: backup

Mamoru Takenaka

Role: primary

Shunsuke Omoto

Role: backup

Masaki Kuwatani

Role: primary

Ryou Sugiura

Role: backup

Hirofumi Kogure

Role: primary

Kei Saito

Role: backup

Ichiro Yasuda

Role: primary

Nobuhiko Hayashi

Role: backup

Masayuki Kitano

Role: primary

Takashi Tamura

Role: backup

Sumio Hirose

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 23100216 (View on PubMed)

Saito 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.

Reference Type: DERIVED

PMID: 39182137 (View on PubMed)

Other Identifiers

2023002P

Identifier Type: -

Identifier Source: org_study_id