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

Primary Purpose

Pancreatic Pseudocyst

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

EUS-guided pancreatic pseudocyst drainage

About this trial

This is an interventional treatment trial for Pancreatic Pseudocyst focused on measuring EUS, pancreatic pseudocyst, drainage

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xijing Institute of digestive diseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Naso-pancreatic tube

Stents

Arm Description

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

The patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and pancreatic pseudocyst.

Outcomes

Primary Outcome Measures

recurrence rate of pancreatic pseudocyst

Secondary Outcome Measures

The complication rate

Full Information

NCT ID

NCT01585662

First Posted

April 19, 2012

Last Updated

April 24, 2012

Sponsor

Xiaoyin Zhang

1. Study Identification

Unique Protocol Identification Number

NCT01585662

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiaoyin Zhang

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Pseudocyst

Keywords

EUS, pancreatic pseudocyst, drainage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Naso-pancreatic tube

Arm Type

Experimental

Arm Description

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

Arm Title

Stents

Arm Type

Experimental

Arm Description

The patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and pancreatic pseudocyst.

Intervention Type

Procedure

Intervention Name(s)

EUS-guided pancreatic pseudocyst drainage

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

recurrence rate of pancreatic pseudocyst

Time Frame

12 months

Secondary Outcome Measure Information:

Title

The complication rate

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoyin Zhang, MD,PhD

Phone

86-29-84771540

zhangxy@fmmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xin Wang, MD,PhD

Phone

86-29-84771516

wangx@fmmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wu Kaichun, MD,PhD

Organizational Affiliation

The forth military medical university

Official's Role

Study Chair

Facility Information:

Facility Name

Xijing Institute of digestive diseases

City

Xian city

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoyin Zhang, MD,PhD

Phone

86-29-84771540

zhangxy@fmmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Xin Wang, MD,PhD

Phone

86-29-84771516

wangx@fmmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Xiaoyin Zhang, MD,PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

11023579

Citation

Baron TH, Wiersema MJ. EUS-guided transesophageal pancreatic pseudocyst drainage. Gastrointest Endosc. 2000 Oct;52(4):545-9. doi: 10.1067/mge.2000.108928. No abstract available.

Results Reference

background

PubMed Identifier

17055880

Citation

Seewald S, Thonke F, Ang TL, Omar S, Seitz U, Groth S, Zhong Y, Yekebas E, Izbicki J, Soehendra N. One-step, simultaneous double-wire technique facilitates pancreatic pseudocyst and abscess drainage (with videos). Gastrointest Endosc. 2006 Nov;64(5):805-8. doi: 10.1016/j.gie.2006.07.049.

Results Reference

background

PubMed Identifier

17454865

Citation

Lopes CV, Pesenti C, Bories E, Caillol F, Giovannini M. Endoscopic-ultrasound-guided endoscopic transmural drainage of pancreatic pseudocysts and abscesses. Scand J Gastroenterol. 2007 Apr;42(4):524-9. doi: 10.1080/00365520601065093.

Results Reference

background

PubMed Identifier

18226686

Citation

Barthet M, Lamblin G, Gasmi M, Vitton V, Desjeux A, Grimaud JC. Clinical usefulness of a treatment algorithm for pancreatic pseudocysts. Gastrointest Endosc. 2008 Feb;67(2):245-52. doi: 10.1016/j.gie.2007.06.014.

Results Reference

background

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

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