A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis

Walled-off Necrosis Clinical Trial

Official title:

Efficacy and Safety of Double-pigtail Plastic Versus Lumen-apposing Metal Stents for Transmural Drainage of Walled-off Necrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04876235
• Other study ID #: 2021-03-221
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Obtention of a written informed consent

• According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON

• The diameter of WON =6cm

• Patient capable of fill in the quality of life questionnaire

• The distance between the EUS-probe and WON was < 1 cm.

Exclusion Criteria:

• No written informed consent

• pancreatic cystic tumor, pancreatic cancer and other benign and malignant tumors

• pancreatic pseudocyst

• WON too far from the stomach and duodenum to perform endoscopic drainage

• Serious abnormalities in liver and kidney function and coagulation function

• Pregnant, parturient or breastfeeding women

Related Conditions & MeSH terms

• Necrosis
• Walled-off Necrosis

Intervention

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
• double-pigtail plastic stents
In the DPPS group, patients were stented with DPPS

Locations

Country	Name	City	State
China	Jianfeng Yang	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical success (clinical improvement and resolution of WON)	compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis	two months
Secondary	Adverse Events	Number of participants with adverse events; type, frequency and intensity of adverse events	two months