Endoscopic Retrograde Cholangiopancreatography, Pancreaticobiilary Diseases
Conditions
Keywords
ERCP, Fully Covered Self-expandable Metal Stent
Brief summary
Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has the advantage of longer patency. Proximal or distal migration is one of major disadvantages of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports. We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease the migration rate and migration-related cholangitis.
Interventions
DEVICEFCSEMS plus Clip
After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.
DEVICEFCSEMS
FCSEMS was released as the same as mentioned above. No fixating method was used.
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Huaihe Hospital of Henan University
Xiamen Humanity Hospital
The Third Affiliated Hospital of Second Military Medical University
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 2. Patients with ERCP indications who were suitable for FCSEMS placement, such as benign or malignant biliary stricture, difficult CBDS, biliary or papillary bleeding, bile leak or perforation etc.
Exclusion criteria
1. Expected life span ≤6 months 2. Considering tumor resection within 6 months 3. Failed CBD cannulation 4. Hilar stricture (Bismuth II, III and IV) 5. CBD dilating by a balloon catheter with diameter≥8mm 6. Inserting the whole FCSEMS into CBD and the distal end of FCSEMS invisible in endoscopic view 7. Maximal CBD diameter ≤6mm 8. Pregnancy or lactation 9. Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migration rate of FCSEMS | 6 months | The proportion of patients who had stent migration after placing FCSEMS, which was defined as radiological or endoscopic evidence of distal or proximal migration within 6 months after placing FCSEMS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distal migration rate | 6 months | The proportion of patients who had distal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially distal migration of the stent out of CBD during follow up. Fully distal migration: The whole stent was out of CBD or disappeared in fluoroscopy. Partially distal migration: More than half length of FCSEMS was visible in endoscopic view. |
| Proximal migration rate | 6 months | The proportion of patients who had proximal migration of FCSEMS, which was defined as radiological or endoscopic evidence of fully or partially proximal migration of the stent into CBD during follow up. Fully proximal migration: The whole stent was in CBD and the distal end was not visible. Partially proximal migration: Less than 0.5cm of distal end of FCSEMS was visible in endoscopic view. |
| Rate of cholangitis after FCSEMS placement | 6 months | The proportion of patients who had the complication of cholangitis during follow up, due to stent migration, tumor/tissue ingrowth or food impaction. |
| Complications related to stent removal | 6 months | Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal. |
Countries
China
Outcome results
None listed