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

April 19, 2012
April 24, 2012
January 2012
December 2014   (final data collection date for primary outcome measure)
recurrence rate of pancreatic pseudocyst [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01585662 on ClinicalTrials.gov Archive Site
The complication rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective Random Comparing Study on EUS-guided Pseudocyst Drainage by Naso-pancreatic Tube and Stents
Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Pseudocyst
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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact: Xiaoyin Zhang, MD,PhD 86-29-84771540 zhangxy@fmmu.edu.cn
Contact: Xin Wang, MD,PhD 86-29-84771516 wangx@fmmu.edu.cn
China
 
NCT01585662
1111
No
Xiaoyin Zhang, Fourth Military Medical University
Xiaoyin Zhang
Not Provided
Study Chair: Wu Kaichun, MD,PhD The forth military medical university
Fourth Military Medical University
April 2012

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