Jianfeng Yang
Hangzhou, Zhejiang, 310006, China
NCT Number: NCT04876235
Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid necrotic material that is usually formed 4 weeks after an episode of acute necrotizing pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy and safety of a double mushroom head metal stent and a double pigtail plastic stent in the treatment of encapsulated necrosis of the pancreas.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310006, China
According to the revised Atlanta classification, pancreatic fluid collections (PFCs) include acute peripancreatic fluid collections(APFCs) and acute necrotic collections(ANCs), which, over time, turn into pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON). Drainage of these PP and WON is required when they increase in size and become infected or become symptomatic.
Traditionally, WON has been managed surgically, however, surgical necrosectomy is associated with substantial morbidity and mortality, particularly when pursued early. In recent years, with the development of minimally invasive techniques, Endoscopic ultrasound (EUS)-guided transluminal drainage has evolved to become the treatment of choice for symptomatic pancreatic walled-off necrosis (WON).
Double-pigtail plastic stents(DPPS) is the earliest stent used for WON drainage in ultrasound endoscopy, however, These stents are limited by their small diameter leading to increased risk of stent obstruction. Recently, lumen-apposing metal stents (LAMS) have been increasingly used because of the advantage of better lumen apposition and wider diameter, improving access for endoscopic debridement. However, more adverse events(AEs) such as bleeding have been reported.
This article aims to compare the efficacy and safety of DPPS and LAMS in the treatment of Walled-off necrosis
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients were implanted with stents(DPPS or LAMS)under the EUS
In the LAMS group, patients were stented with LAMS
In the DPPS group, patients were stented with DPPS
Time frame: two months
compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis
Time frame: two months
Number of participants with adverse events; type, frequency and intensity of adverse events
First People's Hospital of Hangzhou
Other
Efficacy and Safety of Double-pigtail Plastic Versus Lumen-apposing Metal Stents for Transmural Drainage of Walled-off Necrosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05451901
Cysts, Digestive System Diseases
Bunkyō-Ku, Tokyo, Japan
View Trial Details