Trials Sponsors Conditions Drugs Pricing

Conditions

Walled-off Necrosis

Keywords

endoscopic ultrasound guided drainageLumen-apposing metal stentdouble-pigtail plastic stentsWalled-off necrosis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Adverse Events
two months

Study Arms (2)

LAMS group

EXPERIMENTAL

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

Procedure: endoscopic ultrasoundDevice: lumen-apposing metal stent

DPPS group

ACTIVE COMPARATOR

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 ultrasoundDevice: double-pigtail plastic stents

Interventions

endoscopic ultrasoundProcedure

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

DPPS groupLAMS group

lumen-apposing metal stentDevice

In the LAMS group, patients were stented with LAMS

LAMS group

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Obtention of a written informed consent
According to Revised Atlanta Classification, abdominal CT/MRI and EUS were diagnosed as WON

Sponsors & Collaborators

First People's Hospital of Hangzhou
Otherlead

Study Sites (1)

Jianfeng Yang

Hangzhou, Zhejiang, 310006, China

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic Imaging

Study Officials

Xiaofeng Zhang, M.S
First People's Hospital of Hangzhou
STUDY DIRECTOR

Enrollment

50 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Deputy irector

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 6, 2021

Study Start

May 1, 2021

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

LAMS group

DPPS group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

LAMS group

DPPS group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations