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2017-02
2017-10
2017-12
106
NCT03022110
Changhai Hospital
Changhai Hospital
INTERVENTIONAL
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts
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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-01-11 | N/A | 2017-01-12 |
2017-01-12 | N/A | 2017-01-16 |
2017-01-16 | N/A | 2017-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: plastic stent Endoscopic Ultrasound-guided Drainage with plastic stent | DEVICE: Endoscopic Ultrasound-guided Drainage
|
| EXPERIMENTAL: lumen-apposing metal stent (LAMS) Endoscopic Ultrasound-guided Drainage with lumen-apposing metal stent | DEVICE: Endoscopic Ultrasound-guided Drainage
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Cyst recurrence rate | up to 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Technical success rate | up to 48 hours | |
| Clinical success rate | up to 12 months | |
| Complication rate | up to 12 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
