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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Pseudocyst

Intervention / Treatment
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* Procedure: EUS-guided pancreatic pseudocyst drainage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naso-pancreatic tube<br>The patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method. | Procedure: EUS-guided pancreatic pseudocyst drainage<br>* EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.<br>* Other names: Two pig tails- stents:5cm long,made by Cook Company;|
| Experimental: Stents<br>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<br>* EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.<br>* Other names: Two pig tails- stents:5cm long,made by Cook Company;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate of pancreatic pseudocyst |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The complication rate |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS, pancreatic pseudocyst, drainage