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Completed

NCT Number: NCT04876235

A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment 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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jianfeng Yang

Hangzhou, Zhejiang, 310006, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Ultrasound

Procedure

All patients were implanted with stents(DPPS or LAMS)under the EUS

Lumen-apposing metal stent

Device

In the LAMS group, patients were stented with LAMS

double-pigtail plastic stents

Device

In the DPPS group, patients were stented with DPPS

Primary outcomes

  1. clinical success (clinical improvement and resolution of WON)

    Time frame: two months

    compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis

Secondary outcomes

  1. Adverse Events

    Time frame: two months

    Number of participants with adverse events; type, frequency and intensity of adverse events

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2021
Registry last updated
Feb 21, 2023

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.

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