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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Huaihe Hospital of Henan University | OTHER |
| Xiamen Humanity Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCSEMS+Clip | Experimental | After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. One to two centimeters of distal end of FCSEMS was left outside of the papilla and the stent was released. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla. |
|
| FCSEMS | Sham Comparator | FCSEMS was released as the same as mentioned above. No fixating method was used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FCSEMS plus Clip | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Migration rate of FCSEMS | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distal migration rate | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Humanity Hospital | Xiamen | Fujian | 361001 | China | ||
| Huaihe Hospital of Henan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38619136 | Derived | Wang X, Shi X, Luo H, Ren G, Wang X, Zhao J, Li H, Ning B, Yi H, Zhong L, Zhang R, Ni Z, Liang S, Xia M, Hu B, Pan Y, Fan D. Effects of Clip Anchoring on Preventing Migration of Fully Covered Self-Expandable Metal Stent in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Oct 1;119(10):2028-2035. doi: 10.14309/ajg.0000000000002813. Epub 2024 Apr 15. |
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| Eastern Hepatobiliary Surgery Hospital |
| OTHER |
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| FCSEMS | Device | FCSEMS was released as the same as mentioned above. No fixating method was used. |
|
| 6 months |
| Proximal migration rate | 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. | 6 months |
| Rate of cholangitis after FCSEMS placement | The proportion of patients who had the complication of cholangitis during follow up, due to stent migration, tumor/tissue ingrowth or food impaction. | 6 months |
| Complications related to stent removal | Including failed extraction of the stent, bleeding or cholangitis which needed further management after stent removal. | 6 months |
| Kaifeng |
| Henan |
| 475000 |
| China |
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710032 | China |
| Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University | Chongqing | 400010 | China |
| The Third Affiliated Hospital of Second Military Medical University | Shanghai | 200433 | China |
| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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