NCT03022110

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 11, 2017

Last Update Submit

January 12, 2017

Conditions

Pancreatic Pseudocyst

Outcome Measures

Primary Outcomes (1)

  • Cyst recurrence rate

    up to 12 months

Secondary Outcomes (3)

  • Technical success rate

    up to 48 hours

  • Clinical success rate

    up to 12 months

  • Complication rate

    up to 12 months

Study Arms (2)

plastic stent

ACTIVE COMPARATOR

Endoscopic Ultrasound-guided Drainage with plastic stent

Device: Endoscopic Ultrasound-guided Drainage

lumen-apposing metal stent (LAMS)

EXPERIMENTAL

Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent

Device: Endoscopic Ultrasound-guided Drainage

Interventions

Endoscopic Ultrasound-guided DrainageDEVICE

Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound

lumen-apposing metal stent (LAMS)plastic stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic CystCystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 16, 2017

Study Start

February 1, 2017

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

January 16, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share