Pancreatic Pseudocyst
Conditions
Brief summary
The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and double pigtail plastic stents (DPPSs) on the drainage of pancreatic walled-off necrosis (WON), mainly to observe the efficacy and safety of LAMS for WON.
Detailed description
Patient with pancreatic walled-off necrosis (WON) would be treated randomized with lumen-apposing metal stent (LAMS) or double pigtail plastic stents (DPPSs) under the guidance of Endoscopic Ultrasonography. The investigators compare the effect of the two stents, including technical success, clinical success, adverse event, recurrence, and so on.
Interventions
DEVICELumen-apposing metal stent (LAMS)
Endoscopic Ultrasound-guided Drainage of WON with LAMS
DEVICEDouble pigtail plastic stent (DPPS)
Endoscopic Ultrasound-guided Drainage of WON with DPPS
Sponsors
Yiqi Du
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 | Description |
|---|---|---|
| clinical success | uo to 1 months | The cysts completely disappeared, or diameter ≤ 2cm in the imaging follow-up symptoms have eased |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse event | up to 2months/ stent remove | any adverse event occured after stent inserted |
| recurrence rate | up to 12 months | After the clinical success, imaging examination show cyst again and accompanied by symptoms |
| technical success | up to 48 hours | Stent placed through the wall bracket and pancreatic pseudocyst successfully |
Outcome results
None listed