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

Pancreatic Pseudocyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01585662
• Other study ID #: 1111
• Status: Recruiting
• Phase: Phase 4
• First received: April 19, 2012
• Last updated: April 24, 2012
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2012
• Source: Fourth Military Medical University
• Contact: Xiaoyin Zhang, MD,PhD
• Phone: 86-29-84771540
• Email: zhangxy[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Adults with ages from 18-80 years old.

2. The pseudocysts were formed more than 3 months.

3. The size of pseudocyst is more than 5 cm.

4. The patient has the symptoms related with the pseudocyst.

5. The distance between gastric and the wall of the pseudocyst is less than 1 cm from CT image.

6. The consent form has been signed.

Exclusion Criteria:

1. The patient can't accept the endoscopic procedure.

2. The patient has blood coagulation dysfunction.

3. The patient has mental disorders.

4. The patient has mild or severe cardiorespiratory insufficiency.

5. The patient has hypertension and can't be controlled to safe level.

6. Diabetics whose blood sugar level can't be controlled to safe level.

7. Patients with alcohol dependence

8. Pregnant and lactating women.

9. The patients the investigator don't think suitable for this study.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Pseudocyst

Intervention

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.

Locations

Country	Name	City	State
China	Xijing Institute of digestive diseases	Xian city	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoyin Zhang

Country where clinical trial is conducted

China, 

References & Publications (4)

Baron TH, Wiersema MJ. EUS-guided transesophageal pancreatic pseudocyst drainage. Gastrointest Endosc. 2000 Oct;52(4):545-9. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate of pancreatic pseudocyst		12 months	No
Secondary	The complication rate		12 months	Yes