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| Name | Class |
|---|---|
| Hospital Mutua de Terrassa | OTHER |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
| Institut d'Investigació Biomèdica de Bellvitge | OTHER |
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There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- Single biliary LAMS | Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent after failed ERCP cannulation or inaccessible papilla. |
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| 2- Biliary LAMS plus Doublu-Pigtail plastic Etent | Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent (plus double-pigtail plastic stent) after failed ERCP cannulation or inaccessible papilla. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic biliary transmural drainage | Device | Endosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction. Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent. |
| Measure | Description | Time Frame |
|---|---|---|
| Potential benefits | to respond if a coaxial DPS within a biliary LAMS really has a potential benefit in the EUS-BD (less number of adverse events: cholangitis, bleeding, sump syndrome, cholestasis secondary to stent biliary obstruction) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Technical success was defined as a successful stent placement between the extrahepatic bile duct and duodenal lumen in a single step approach and determined by endoscopy and fluoroscopy | 24 hours |
| Clinical success |
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Inclusion Criteria:
Exclusion Criteria:
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Palliative malignant biliopancreatic pathology
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Mútua de Terrassa | Terrassa | Barcelona, Catalonia | 08221 | Spain | ||
| Hospital Universitari de Bellvitge |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D016609 | Neoplasms, Second Primary |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D002768 | Choledochostomy |
| ID | Term |
|---|---|
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
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Clinical success was defined as a reduction in bilirubin by 50% at 2-weeks after stent placement, meaning that the biliary stent was functional.
| 4 weeks |
| Procedure time | Procedure time was defined from the insertion of the endoscope to its removal. | 2 hours |
| Biliary reintervention | Biliary reintervention: the need to perform additional interventions to achieve biliary drainage. | 6 months |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| Hospital de Sant Pau i de la Santa Creu | Barcelona | Catalonia | 08041 | Spain |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |