Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

March 28, 2018 updated by: Yiqi Du
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.

Study Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject with ages from 18-80 years old
  2. Subject with pancreatic pseudocysts confirmed by CT
  3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
  4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
  5. Subject has the symptoms related with the pseudocyst
  6. The consent form has been signed

Exclusion Criteria:

  1. Subject is younger than 18 years or older than 80 years
  2. Pancreatic pseudocyst communicate with the main pancreatic duct
  3. Subject can't accept the endoscopic procedure
  4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
  5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
  6. Subject with 2 or more than 2 cysts
  7. Subject has blood coagulation dysfunction
  8. Pregnant or subject has mental disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumen-apposing metal stent(LAMS)
Lumen-apposing metal stent(LAMS) will be deployed by endoscopist under the guidance of EUS
Device: Lumen-apposing metal stent (LAMS)
Endoscopic Ultrasound-guided Drainage of WON with LAMS
Active Comparator: Double pigtail plastic stent(DPPS)
Double pigtail plastic stent(DPPS) will be deployed by endoscopist under the guidance of EUS
Device: Double pigtail plastic stent (DPPS)
Endoscopic Ultrasound-guided Drainage of WON with DPPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success
Time Frame: uo to 1 months
The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased
uo to 1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse event
Time Frame: up to 2months/ stent remove
any adverse event occured after stent inserted
up to 2months/ stent remove
recurrence rate
Time Frame: up to 12 months
After the clinical success, imaging examination show cyst again and accompanied by symptoms
up to 12 months
technical success
Time Frame: up to 48 hours
Stent placed through the wall bracket and pancreatic pseudocyst successfully
up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yiqi Du

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

January 14, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017010302

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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