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

NCT ID: NCT04876235

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-12-31

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.

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

Conditions

Walled-off Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LAMS group

place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary

Group Type: EXPERIMENTAL

endoscopic ultrasound

Intervention Type: PROCEDURE

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

lumen-apposing metal stent

Intervention Type: DEVICE

In the LAMS group, patients were stented with LAMS

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

Group Type: ACTIVE_COMPARATOR

endoscopic ultrasound

Intervention Type: PROCEDURE

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

double-pigtail plastic stents

Intervention Type: DEVICE

In the DPPS group, patients were stented with DPPS

Interventions

endoscopic ultrasound

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

Intervention Type: PROCEDURE

lumen-apposing metal stent

In the LAMS group, patients were stented with LAMS

Intervention Type: DEVICE

double-pigtail plastic stents

In the DPPS group, patients were stented with DPPS

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Yang

Deputy irector

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaofeng Zhang, M.S

Role: STUDY_DIRECTOR

First People's Hospital of Hangzhou

Locations

Jianfeng Yang

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2021-03-221

Identifier Type: -

Identifier Source: org_study_id