Endoscopic Ultrasound-guided Drainage of Pancreatic Pseud... | NCT03022110

Studies
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

NCT03022110

Sponsor

Yiqi Du

Status

Unknown status

Last Update Posted

Jan 16, 2017Estimated

Enrollment

106Estimated

Phase

Not Applicable

Conditions

Pancreatic Pseudocyst

Interventions

Endoscopic Ultrasound-guided Drainage

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2017

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 12, 2017

First Posted Date

Jan 16, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2017

Last Update Posted Date

Jan 16, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Inclusion criteria

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

Exclusion criteria

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Ultrasound-guided Drainage	Device	Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound	lumen-apposing metal stent (LAMS) plastic stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cyst recurrence rate		up to 12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010192	Pancreatic Pseudocyst

Ancestor Terms

ID	Term
D010181	Pancreatic Cyst
D003560	Cysts
D009369	Neoplasms
D010182	Pancreatic Diseases

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