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

Primary Purpose

Walled-off Necrosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endoscopic ultrasound
lumen-apposing metal stent
double-pigtail plastic stents
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Walled-off Necrosis focused on measuring endoscopic ultrasound guided drainage, Lumen-apposing metal stent, double-pigtail plastic stents, Walled-off necrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jianfeng Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LAMS group

DPPS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2021
Last Updated
February 17, 2023
Sponsor
First People's Hospital of Hangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT04876235
Brief Title
A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis
Official Title
Efficacy and Safety of Double-pigtail Plastic Versus Lumen-apposing Metal Stents for Transmural Drainage of Walled-off Necrosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Walled-off Necrosis
Keywords
endoscopic ultrasound guided drainage, Lumen-apposing metal stent, double-pigtail plastic stents, Walled-off necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LAMS group
Arm Type
Experimental
Arm Description
place LAMS under endoscopic ultrasound. Direct endoscopic necrosectomy(DEN) was performed through the LAMS with a forward viewing gastroscope if necessary
Arm Title
DPPS group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
endoscopic ultrasound
Intervention Description
All patients were implanted with stents(DPPS or LAMS)under the EUS
Intervention Type
Device
Intervention Name(s)
lumen-apposing metal stent
Intervention Description
In the LAMS group, patients were stented with LAMS
Intervention Type
Device
Intervention Name(s)
double-pigtail plastic stents
Intervention Description
In the DPPS group, patients were stented with DPPS
Primary Outcome Measure Information:
Title
clinical success (clinical improvement and resolution of WON)
Description
compare rates of WON resolution in patients with LAMS and DPPS for treatment of walled-off necrosis
Time Frame
two months
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants with adverse events; type, frequency and intensity of adverse events
Time Frame
two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhang, M.S
Organizational Affiliation
First People's Hospital of Hangzhou
Official's Role
Study Director
Facility Information:
Facility Name
Jianfeng Yang
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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