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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01585662

Enrollment

Registered

2012-04-26

Start date

2012-01-31

Completion date

2014-12-31

Last updated

2012-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Pseudocyst

Keywords

EUS, pancreatic pseudocyst, drainage

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.

Interventions

PROCEDUREEUS-guided pancreatic pseudocyst drainage

EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
recurrence rate of pancreatic pseudocyst	12 months

Secondary

Measure	Time frame
The complication rate	12 months

Countries

China

Contacts

Primary ContactXiaoyin Zhang, MD,PhD

zhangxy@fmmu.edu.cn86-29-84771540

Backup ContactXin Wang, MD,PhD

wangx@fmmu.edu.cn86-29-84771516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026