Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts: A Multi-center Randomized Controlled Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03022110

Enrollment

106

Registered

2017-01-16

Start date

2017-02-28

Completion date

2017-12-31

Last updated

2017-01-16

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

Conditions

Pancreatic Pseudocyst

Brief summary

The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.

Detailed description

Inclusion criteria 1. Subject with ages from 18-80 years old 2. Subject with pancreatic pseudocysts confirmed by CT 3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months 4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall 5. Subject has the symptoms related with the pseudocyst 6. The consent form has been signed Exclusion criteria 1. Subject is younger than 18 years or older than 80 years 2. Pancreatic pseudocyst communicate with the main pancreatic duct 3. Subject can't accept the endoscopic procedure 4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess 5. The distance between gastric and the wall of the pseudocyst is more than 1 cm 6. Subject with 2 or more than 2 cysts 7. Subject has blood coagulation dysfunction 8. Pregnant or subject has mental disorders

Interventions

DEVICEEndoscopic Ultrasound-guided Drainage

Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Subject with ages from 18-80 years old 2. Subject with pancreatic pseudocysts confirmed by CT 3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months 4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall 5. Subject has the symptoms related with the pseudocyst 6. The consent form has been signed

Exclusion criteria

1. Subject is younger than 18 years or older than 80 years 2. Pancreatic pseudocyst communicate with the main pancreatic duct 3. Subject can't accept the endoscopic procedure 4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess 5. The distance between gastric and the wall of the pseudocyst is more than 1 cm 6. Subject with 2 or more than 2 cysts 7. Subject has blood coagulation dysfunction 8. Pregnant or subject has mental disorders

Design outcomes

Primary

Measure	Time frame
Cyst recurrence rate	up to 12 months

Secondary

Measure	Time frame
Technical success rate	up to 48 hours
Clinical success rate	up to 12 months
Complication rate	up to 12 months

Outcome results

None listed

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