Prospective Random Comparing Study on EUS-guided Pseudocyst Drainage by Naso-pancreatic Tube and Stents

This study is currently recruiting participants.

Verified April 2012 by Fourth Military Medical University

Sponsor:

Information provided by (Responsible Party):

Xiaoyin Zhang, Fourth Military Medical University

ClinicalTrials.gov Identifier:

NCT01585662

First received: April 19, 2012

Last updated: April 24, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2012

Last Updated Date

April 24, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

recurrence rate of pancreatic pseudocyst [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01585662 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The complication rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prospective Random Comparing Study on EUS-guided Pseudocyst Drainage by Naso-pancreatic Tube and Stents

Official Title ^ICMJE

Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage

Brief Summary

EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to place several stents to drain the content of cyst into GI tract. In the investigators experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified naso-pancreatic tube drainage method were found recurrent with a follow up period from 3 months-34 months. So, the investigators designed this prospective random comparing study to confirm the result.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pancreatic Pseudocyst

Intervention ^ICMJE

Procedure: EUS-guided pancreatic pseudocyst drainage

EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.

Other Names:

Naso-pancreatic drainage tube:8 Fren,made by Cook Company
Two pig tails- stents:5cm long,made by Cook Company

Study Arm (s)

Experimental: Naso-pancreatic tube
The patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method.

Intervention: Procedure: EUS-guided pancreatic pseudocyst drainage
Experimental: Stents
The patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and pancreatic pseudocyst.

Intervention: Procedure: EUS-guided pancreatic pseudocyst drainage

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults with ages from 18-80 years old.
The pseudocysts were formed more than 3 months.
The size of pseudocyst is more than 5 cm.
The patient has the symptoms related with the pseudocyst.
The distance between gastric and the wall of the pseudocyst is less than 1 cm from CT image.
The consent form has been signed.

Exclusion Criteria:

The patient can't accept the endoscopic procedure.
The patient has blood coagulation dysfunction.
The patient has mental disorders.
The patient has mild or severe cardiorespiratory insufficiency.
The patient has hypertension and can't be controlled to safe level.
Diabetics whose blood sugar level can't be controlled to safe level.
Patients with alcohol dependence
Pregnant and lactating women.
The patients the investigator don't think suitable for this study.

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Xiaoyin Zhang, MD,PhD	86-29-84771540	zhangxy@fmmu.edu.cn
Contact: Xin Wang, MD,PhD	86-29-84771516	wangx@fmmu.edu.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01585662

Other Study ID Numbers ^ICMJE

1111

Has Data Monitoring Committee

Responsible Party

Xiaoyin Zhang, Fourth Military Medical University

Study Sponsor ^ICMJE

Xiaoyin Zhang

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Wu Kaichun, MD,PhD

The forth military medical university

Information Provided By

Fourth Military Medical University

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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