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

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

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.

Study Overview

• Status: Completed
• Conditions: Walled-off Necrosis
• Intervention / Treatment: Procedure: endoscopic ultrasound; Device: lumen-apposing metal stent; Device: double-pigtail plastic stents

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Jianfeng Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of participants with adverse events; type, frequency and intensity of adverse events	two months

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Investigators: Study Director: Xiaofeng Zhang, M.S, First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Walled-off necrosis; endoscopic ultrasound guided drainage; Lumen-apposing metal stent; double-pigtail plastic stents
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: 2021-03-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No