Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

Pancreatic Pseudocyst Clinical Trial

Official title:

Endoscopic Ultrasound-guided Drainage of Walled Off Necrosis (WON)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03027895
• Other study ID #: 2017010302
• Status: Not yet recruiting
• Phase: N/A
• First received: January 14, 2017
• Last updated: March 28, 2018
• Start date: September 2018
• Est. completion date: September 2020

Study information

• Verified date: March 2018
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Necrosis
• Pancreatic Pseudocyst

Intervention

Device:
• Lumen-apposing metal stent (LAMS)
Endoscopic Ultrasound-guided Drainage of WON with LAMS
• Double pigtail plastic stent (DPPS)
Endoscopic Ultrasound-guided Drainage of WON with DPPS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yiqi Du

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical success	The cysts completely disappeared, or diameter = 2cm in the imaging follow-up symptoms have eased	uo to 1 months
Secondary	adverse event	any adverse event occured after stent inserted	up to 2months/ stent remove
Secondary	recurrence rate	After the clinical success, imaging examination show cyst again and accompanied by symptoms	up to 12 months
Secondary	technical success	Stent placed through the wall bracket and pancreatic pseudocyst successfully	up to 48 hours