A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LAMS group place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary |
Procedure: endoscopic ultrasound
All patients were implanted with stents（DPPS or LAMS）under the EUS
Device: lumen-apposing metal stent
In the LAMS group, patients were stented with LAMS
|
| Active Comparator: DPPS group Place DPPS under endoscopic ultrasound. When required, DEN was performed once the cystogastrostomy/duodenostomy tract had matured. This was done by first removing the stents followed by dilation of the tract with a radial expansion balloon and insertion of a forward viewing gastroscope through the tract for DEN |
Procedure: endoscopic ultrasound
All patients were implanted with stents（DPPS or LAMS）under the EUS
Device: double-pigtail plastic stents
In the DPPS group, patients were stented with DPPS
|
Outcome Measures
Primary Outcome Measures
- clinical success (clinical improvement and resolution of WON) [two months]
compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis
Secondary Outcome Measures
- Adverse Events [two months]
Number of participants with adverse events; type, frequency and intensity of adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Obtention of a written informed consent
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According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON
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The diameter of WON ≥6cm
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Patient capable of fill in the quality of life questionnaire
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The distance between the EUS-probe and WON was < 1 cm.
Exclusion Criteria:
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No written informed consent
-
pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors
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pancreatic pseudocyst
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WON too far from the stomach and duodenum to perform endoscopic drainage
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Serious abnormalities in liver and kidney function and coagulation function
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Pregnant, parturient or breastfeeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jianfeng Yang | Hangzhou | Zhejiang | China | 310006 |
Sponsors and Collaborators
- First People's Hospital of Hangzhou
Investigators
- Study Director: Xiaofeng Zhang, M.S, First People's Hospital of Hangzhou
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-03-221