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

Phase 4

• Conditions: Pancreatic Pseudocyst
• Interventions: Procedure: EUS-guided pancreatic pseudocyst drainage

• Registration Number: NCT01585662
• Lead Sponsor: Xiaoyin Zhang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-04
• Study First Submitted: 2012-04-19
• Study First Submitted QC: 2012-04-24
• Last Update Submitted: 2012-04-24
• Study First Posted: 2012-04-26
• Last Update Posted: 2012-04-26
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naso-pancreatic tube	EUS-guided pancreatic pseudocyst drainage	The patients enrolled in this group will be treated with modified naso-pancreatic tube drainage method.
Stents	EUS-guided pancreatic pseudocyst drainage	The patients enrolled this group will be treated by placing the stents (at least 2 stents) between gastric and pancreatic pseudocyst.

Primary Outcome Measures

Name	Time	Method
recurrence rate of pancreatic pseudocyst	12 months

Secondary Outcome Measures

Name	Time	Method
The complication rate	12 months

Trial Locations

Locations (1)

Xijing Institute of digestive diseases; 🇨🇳 Xian city, Shanxi, China