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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Pancreatic Pseudocyst
Procedure: EUS-guided pancreatic pseudocyst drainage
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage

Further study details as provided by Fourth Military Medical University:

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

Secondary Outcome Measures:
  • The complication rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naso-pancreatic tube
The patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method.
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: Stents
The patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and 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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585662

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

Locations
China, Shanxi
Xijing Institute of digestive diseases Recruiting
Xian city, Shanxi, China, 710032
Contact: Xiaoyin Zhang, MD,PhD    86-29-84771540    zhangxy@fmmu.edu.cn   
Contact: Xin Wang, MD,PhD    86-29-84771516    wangx@fmmu.edu.cn   
Principal Investigator: Xiaoyin Zhang, MD,PhD         
Sponsors and Collaborators
Xiaoyin Zhang
Investigators
Study Chair: Wu Kaichun, MD,PhD The forth military medical university
  More Information

Publications:
Responsible Party: Xiaoyin Zhang, Associate professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01585662     History of Changes
Other Study ID Numbers: 1111
Study First Received: April 19, 2012
Last Updated: April 24, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fourth Military Medical University:
EUS
pancreatic pseudocyst
drainage

Additional relevant MeSH terms:
Pancreatic Pseudocyst
Pancreatic Cyst
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 21, 2014