Digestive System Diseases

All Conditions

Neoplasms

Symptoms and General Pathology

Pancreatitis

Pancreatic Pseudocyst

Pancreatic Diseases

Gastrointestinal Diseases

Cysts

Pancreatic Cyst

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.

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.

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

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

Yousuke Nakai

Tomotaka Saito

Tadahisa Inoue

Hiroyuki Isayama

Toshio Fujisawa

Sho Takahashi

Hiroshi Ohyama

Koji Takahashi

Nao Fujimori

Kazuhide Matsumoto

Keisuke Iwata

Mitsuru Okuno

Akinori Maruta

Kensaku Yoshida

Takuji Iwashita

Shinya Uemura

Hideyuki Shiomi

Ryota Nakano

Hideki Kamada

Ryota Nakabayashi

Shinichi Hashimoto

Makoto Hinokuchi

Toshiyasu Shiratori

So Nakaji

Kazunari Nakahara

Yusuke Satta

Tsuyoshi Mukai

Saburo Matsubara

Kentaro Suda

Shinpei Doi

Nobuhiro Katsukura

Atsuhiro Masuda

Arata Sakai

Masahiro Tsujimae

Reiko Yamada

Kenji Nose

Hironari Kato

Kazuyuki Matsumoto

Ryosuke Sato

Takeshi Ogura

Saori Ueno

Masaki Kuwatani

Ryou Sugiura

Hirofumi Kogure

Kei Saito

Ichiro Yasuda

Nobuhiko Hayashi

Masayuki Kitano

Takashi Tamura

Sumio Hirose

Mamoru Takenaka

Shunsuke Omoto

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.

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.

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

WONDER-02: Plastic Stent vs. Lumen-apposing Metal Stent for Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts-a Multicentre Randomised Non-inferiority Trial

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.

The adverse events are defined and graded by the ASGE lexicon guideline.

Technical success is defined as the successful placement of any stent in the targeted pseudocyst during the initial EUS-guided drainage.

Time from randomization to clinical success

Gastrointestinal obstruction due to a pseudocyst

Time requiring endoscopic drainage for a pseudocyst

Time requiring percutaneous drainage for a pseudocyst

Total number of interventions needed for the treatment of a pseudocyst

Total procedure time needed for the treatment of a pseudocyst

Total ICU stay of the index hospitalisation

Incidence of pseudocyst recurrence after clinical success

Time from clinical success to recurrence of pancreatic pseudocyst

Total treatment days for recurrent pancreatic pseudocyst

Incidence of new-onset pancreatic pseudocyst

Total treatment days for new-onset pancreatic pseudocyst

The start of medications for pancreatic exocrine insufficiency and the date

The presence of sarcopenia and the date of diagnosis

Change in volume of pancreas. Volume is evaluated by contrast-enhanced Computed Tomography (CT) using SYNAPSE VINCENT (FUJIFILM).

Success rate of surgeries associated with pancreatic pseudocyst

New-onset clinical symptoms associated with pancreatic exocrine insufficiency, such as steatorrhea , constipation, diarrhea, maldigestion, flatulence, and tenesmus

Tokyo University

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

Rare Diseases

Carcinoma

Cholangiocarcinoma

Biliary Tract Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Bile Duct Cancer

Biliary Tract Cancer

Intrahepatic Cholangiocarcinoma

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.

The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.

radioactive stent carrying seed iodine 125

radioactive stent

common plastic stent without carrying seed iodine 125

plastic stent

Yan Liu, MD,PhD

Zhaoshen Li, Doctor

Min Min, M.D. PhD.

Yan Liu, Doctor

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

The investigators will conduct CT test or MRI scan after the implantation of the stents in order to measure the tumor size of each patients and evaluate the best tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.0).

In order to research the progression-free survival, the investigators will check the presence of progression disease for each patients until the date of disease progression or death.

Overall survival was calculated from the date of randomization until the date of death.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Changhai Hospital

307 Hospital of PLA

PhD, MD. Chairman of Department of Gastroenterology and Hepatology, 307 Hospital of PLA

Klatskin Tumor

Gastrointestinal Agents

Bismuth

metallic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

biliary stent (self expandable metallic stent)

plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

apichat sangchan, MD

The purpose of this study is to compare the adequacy of unilateral endoscopic biliary drainage using metallic stent with plastic stent in unresectable, complex, hilar, cholangiocarcinoma and cost analysis.

There are two types of biliary stents: 1) the plastic stent made from polyethylene or polytetrafluoroethylene; and, 2) the metal stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10 mm. The main drawback of the plastic stent is the relatively high occlusion rate, but its advantage is the lower cost. The use of a metal stent for hilar tumor has many theoretical advantages: 1) the flexible open-mesh design should allow drainage of secondary duct branches; and, 2) its larger diameter may provide better drainage and longer patency (\~3-9 months).

Whether one type of stent is superior in terms of adequacy of drainage or cost-effectiveness remains undefined. Therefore, we would conduct this study to assess the efficacy of drainage of endoscopically-inserted, unilateral, plastic stents vs. metallic stents in unresectable, complex, hilar cholangiocarcinoma patients.

Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma

Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Unresectable Complex Hilar Cholangiocarcinoma; a Randomized Controlled Trial

Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively in each patient.

Successful drainage was defined as a decrease in total bilirubin level to less than 30% or 50% of pretreatment level within two and four weeks respectively.

survival times of the patients after the first stent insertion

cost per quality adjusted life year (QALY)of metallic stent and plastic stent calculated from Markov model using transitional probabilities, cost and utilities from this study and the available literature

Khon Kaen University

Assist. Prof.

SEMS

Plastic Stent

Total

Age, Categorical

Age Continuous

Sex: Female, Male

Thailand

Region of Enrollment

Assist. Prof. Apichat Sangchan

All 108 participants enrolled into the study were analyzed based on ITT analysis basis.(54 participants in each group)

Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(ITT Analysis)

Patients Survival Times

Simulation cohort of any number of the patients (1, 100 or 1,000 patients) enter the Markov model using transitional probabilities, cost data, utility data from this study and available literature to calculate the cost effectiveness ratio of metallic stent and plastic stent in unresectable complex hilar cholangiocarcinoma

Cost Effective Ratio of Metallic and Plastic Stent

91 participants who had successful stent insertion were analyzed based on per protocol analysis.

Proportion of Patients With Adequate Biliary Drainage in Metallic Stent and Plastic Stent Group.(Per Protocol Analysis)

Overall Study

Behaviors and Mental Disorders

Quality of Life

Metallic stent of plastic stent was inserted into right or left hepatic duct which was planed before intervention using CT scan or MRCP

biliary stent

Worrarat Kongkasame, MD

The purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.

In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.

The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.

There are two types of biliary stent:

1. plastic stent made from polyethylene or polytetrafluoroethylene
2. metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.

The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.

In the reasons of higher occlusion rate , the lower cost of plastic stent versus metallic stent that should be stent exchange when occluded, so we would to know about quality of life in both group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
WONDER-02 Trial: Plastic Stent vs. Lumen-apposing Metal Stent for Pancreatic Pseudocysts	NCT06133023	Pancreatic Flui... Pancreatitis Pancreatic Pseu...	Plastic stent LAMS	18 Years -	Tokyo University
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer	NCT02238613	Intrahepatic Ch... Cholangiocarcin... Ampullary Carci... Biliary Obstruc...	radioactive ste... plastic stent	18 Years - 80 Years	307 Hospital of PLA
Efficacy and Cost Analysis of Plastic Stent Compare to Metallic Stent in Hilar Cholangiocarcinoma	NCT00721175	Hilar Cholangio...	biliary stent (... PS	18 Years -	Khon Kaen University
Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent	NCT00746538	Unresectable Hi...	biliary stent	18 Years -	Khon Kaen University
Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent	NCT00746538	Unresectable Hi...	biliary stent	18 Years -	Khon Kaen University
Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent	NCT00746538	Unresectable Hi...	biliary stent	18 Years -	Khon Kaen University
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer	NCT02238613	Intrahepatic Ch... Cholangiocarcin... Ampullary Carci... Biliary Obstruc...	radioactive ste... plastic stent	18 Years - 80 Years	307 Hospital of PLA

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