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

Completed

• Conditions: Oncologic Disorders; Pancreatic Cancer; Endoscopy; Therapy Related Neoplasms
• Interventions: Device: Endoscopic biliary transmural drainage

• Registration Number: NCT04420039
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-09
• Primary Completion: 2020-09
• Study Completion: 2021-03
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-11
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1- Single biliary LAMS	Endoscopic biliary transmural drainage	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.
2- Biliary LAMS plus Doublu-Pigtail plastic Etent	Endoscopic biliary transmural drainage	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.

Primary Outcome Measures

Name	Time	Method
Potential benefits	4 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Technical success	24 hours	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
Clinical success	4 weeks	Clinical success was defined as a reduction in bilirubin by 50% at 2-weeks after stent placement, meaning that the biliary stent was functional.
Procedure time	2 hours	Procedure time was defined from the insertion of the endoscope to its removal.
Biliary reintervention	6 months	Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.

Trial Locations

Locations (3)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitari Mútua de Terrassa; 🇪🇸 Terrassa, Barcelona, Catalonia, Spain

Hospital de Sant Pau i de la Santa Creu; 🇪🇸 Barcelona, Catalonia, Spain