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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06133023
Other study ID # 2023002P
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2023
Est. completion date September 2033

Study information

Verified date November 2023
Source Tokyo University
Contact Yousuke Nakai
Phone +81-3-3815-5411
Email ynakai-tky@umin.ac.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 2033
Est. primary completion date October 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.

Locations

Country Name City State
Japan Department of Gastroenterology, Aichi Medical University Aichi
Japan Department of Gastroenterology, Graduate School of Medicine, Juntendo University Bunkyo-Ku, Tokyo
Japan Department of Gastroenterology, The University of Tokyo Hospital Bunkyo-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 Hyogo
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 Osaka
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

Sponsors (1)

Lead Sponsor Collaborator
Tokyo University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants with treatment-related adverse events The adverse events are defined and graded by the ASGE lexicon guideline. Five years
Secondary Mortality Mortality from any cause Five years
Secondary 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. One day
Secondary Time to clinical success Time from randomization to clinical success Six months
Secondary Incidence of biliary stricture Biliary stricture due to a pseudocyst Five years
Secondary Incidence of gastrointestinal stricture Gastrointestinal obstruction due to a pseudocyst Five years
Secondary Time requiring endoscopic drainage Time requiring endoscopic drainage for a pseudocyst Six months
Secondary Time requiring percutaneous drainage Time requiring percutaneous drainage for a pseudocyst Six months
Secondary Number of interventions Total number of interventions needed for the treatment of a pseudocyst Six months
Secondary Time of interventions Total procedure time needed for the treatment of a pseudocyst Six months
Secondary Length of the index hospitalisation Total days of the index hospitalisation Six months
Secondary Length of ICU stay during the index hospitalisation Total ICU stay of the index hospitalisation Six months
Secondary Duration of antibiotics administration Total administration days of antibiotics Six months
Secondary Costs of interventions Total costs of treatment interventions Six months
Secondary Costs of the index hospitalisation Total costs of the index hospitalisation Six months
Secondary Incidence of pseudocyst recurrence Incidence of pseudocyst recurrence after clinical success Five years
Secondary Time to recurrence of pancreatic pseudocyst Time from clinical success to recurrence of pancreatic pseudocyst Five years
Secondary Treatment duration of recurrent pancreatic pseudocyst Total treatment days for recurrent pancreatic pseudocyst Five years
Secondary New onset of pancreatic pseudocyst Incidence of new-onset pancreatic pseudocyst Five years
Secondary Treatment duration of new onset pancreatic pseudocyst Total treatment days for new-onset pancreatic pseudocyst Five years
Secondary Incidence of new onset diabetes Incidence of new-onset diabetes mellitus Five years
Secondary The presence of medications for pancreatic exocrine insufficiency The start of medications for pancreatic exocrine insufficiency and the date Five years
Secondary The presence of sarcopenia The presence of sarcopenia and the date of diagnosis Five years
Secondary Change in volume of pancreas Change in volume of pancreas. Volume is evaluated by contrast-enhanced Computed Tomography (CT) using SYNAPSE VINCENT (FUJIFILM). Five years
Secondary Success rate of surgical procedures Success rate of surgeries associated with pancreatic pseudocyst Six months
Secondary Operation time of surgical procedures Total operation times Six months
Secondary 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 Five years
Secondary Incidence of new pancreatic cancer New-onset pancreatic cancer Five years
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