Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

Pancreatic Pseudocyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03022110
• Other study ID #: 2017010301
• Status: Not yet recruiting
• Phase: N/A
• First received: January 11, 2017
• Last updated: January 12, 2017
• Start date: February 2017
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• 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 traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 106
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• 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

• Pancreatic Pseudocyst

Intervention

Device:
• Endoscopic Ultrasound-guided Drainage
Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yiqi Du

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cyst recurrence rate		up to 12 months
Secondary	Technical success rate		up to 48 hours
Secondary	Clinical success rate		up to 12 months
Secondary	Complication rate		up to 12 months