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

NCT06133023 | Not Yet Recruiting DMC

• 1 other identifier: 2023002P
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 26

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.

Conditions

Pancreatic Fluid Collection; Pancreatitis; Pancreatic Pseudocyst

Keywords

Endosonography; Drainage; Stents; Pancreatic Pseudocyst

Outcome Measures

Primary Outcomes (1)

• 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.

  Six months

Secondary Outcomes (28)

• Number of participants with treatment-related adverse events

  Five years

• Mortality

  Five years

• Technical success of the initial EUS-guided drainage

  One day

• Time to clinical success

  Six months

• Incidence of biliary stricture

  Five years

Study Arms (2)

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.

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.

Procedure: LAMS

Interventions

Plastic stent 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.

Plastic stent group

LAMS 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.

LAMS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tokyo University: lead

Study Sites (26)

Department of Gastroenterology, Aichi Medical University

Aichi, Japan

Location

Department of Gastroenterology, The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, 113-8655, Japan

Location

Department of Gastroenterology, Graduate School of Medicine, Juntendo University

Bunkyō-Ku, Tokyo, Japan

Location

Department of Gastroenterology, Graduate School of Medicine, Chiba University

Chiba, Japan

Location

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

Fukuoka, Japan

Location

Department of Gastroenterology, Gifu Municipal Hospital

Gifu, Japan

Location

Department of Gastroenterology, Gifu Prefectural General Medical Center

Gifu, Japan

Location

First Department of Internal Medicine, Gifu University Hospital

Gifu, Japan

Location

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

Hyōgo, Japan

Location

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

Kagawa, Japan

Location

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

Kagoshima, Japan

Location

Department of Gastroenterology, Kameda Medical Center

Kamogawa, Japan

Location

Department of Gastroenterology, St. Marianna University School of Medicine

Kanagawa, Japan

Location

Department of Gastroenterological Endoscopy, Kanazawa Medical University

Kanazawa, Japan

Location

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

Kawagoe, Japan

Location

Department of Gastroenterology, Teikyo University Mizonokuchi Hospital

Kawasaki, Japan

Location

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

Kobe, Japan

Location

Department of Gastroenterology and Hepatology, Mie University Hospital

Mie, Japan

Location

Department of Gastroenterology and Hepatology, Okayama University Hospital

Okayama, Japan

Location

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

Osaka, Japan

Location

Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine

Ōsaka, Japan

Location

Department of Gastroenterology and Hepatology, Hokkaido University Hospital

Sapporo, Japan

Location

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

Tokyo, Japan

Location

Third Department of Internal Medicine, University of Toyama

Toyama, Japan

Location

Department of Gastroenterology, Wakayama Medical University School of Medicine

Wakayama, Japan

Location

Department of Gastroenterology, Yamanashi Prefectural Central Hospital

Yamanashi, Japan

Location

Related Publications (2)

• 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.

  PMID: 23100216 BACKGROUND

• 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.

  PMID: 39182137 DERIVED

MeSH Terms

Conditions

Pancreatitis; Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Pancreatic Cyst; Cysts; Neoplasms

Study Officials

• Yousuke Nakai

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousuke Nakai

CONTACT

+81-3-3815-5411; ynakai-tky@umin.ac.jp

Tomotaka Saito

CONTACT

+81-3-3815-5411; tomsaito-gi@umin.ac.jp

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 15, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): September 1, 2033
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (26)