Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

January 12, 2017 updated by: Yiqi Du

Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial

The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Anticipated)

106

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
Active Comparator: plastic stent
Endoscopic Ultrasound-guided Drainage with plastic stent
Device: Endoscopic Ultrasound-guided Drainage
Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound
Experimental: lumen-apposing metal stent (LAMS)
Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent
Device: Endoscopic Ultrasound-guided Drainage
Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cyst recurrence rate
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Technical success rate
Time Frame: up to 48 hours
up to 48 hours
Clinical success rate
Time Frame: up to 12 months
up to 12 months
Complication rate
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

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

Sponsor

Yiqi Du

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

February 1, 2017

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017010301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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