Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage
Phase 4
18 Years
85 Years
18 Years
85 Years
Open (Enrolling)
Both
Pancreatic Pseudocyst
Both
Pancreatic Pseudocyst
Trial Information
Random Comparing Study on Two Different EUS-guided Pseudocyst Drainage Methods--Modified Naso-pancreatic Tube Drainage and Stents Drainage
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
recurrence rate of pancreatic pseudocyst
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Wu Kaichun, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
The forth military medical university
Authority:
China: Ethics Committee
Study ID:
1111
NCT ID:
NCT01585662
Start Date:
January 2012
Completion Date:
December 2014
Related Keywords:
- Pancreatic Pseudocyst
- EUS
- pancreatic pseudocyst
- drainage
- Pancreatic Pseudocyst
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