Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction

Study Overview
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Brief Summary
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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.

Official Title
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Is Useful a Coaxial Plastic Stent Within a Lumen-Apposing Metal Stent For The Palliative Management Of Malignant Biliary Obstruction?

Conditions
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Pancreatic Cancer, Endoscopy, Oncologic Disorders, Therapy Related Neoplasms

Intervention / Treatment
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* Device: Endoscopic biliary transmural drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla Exclusion Criteria: Borderline cancer cases Others type of biliary stents Severe coagulopathy or thrombocytopenia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1- Single biliary LAMS<br>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. | Device: Endoscopic biliary transmural drainage<br>* 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.<br>* Other names: Choledochoduodenostomy;|
| 2- Biliary LAMS plus Doublu-Pigtail plastic Etent<br>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. | Device: Endoscopic biliary transmural drainage<br>* 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.<br>* Other names: Choledochoduodenostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malignant biliary obstrucction, Therapeutic endoscopy, Biliary drainage, Lumen apposing stent, Endoscopic Ultrasound, Pancreatic neoplasm