Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction (LAMSpigBil)

Catalan Institute of Health

Status: Completed

Conditions: Therapy Related Neoplasms; Endoscopy; Oncologic Disorders; Pancreatic Cancer

Treatments: Device: Endoscopic biliary transmural drainage

Study type: Observational

Funder types: Other

Identifiers

NCT04420039

HUBellvitge

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

39 participants in 2 patient groups

1- Single biliary LAMS

Description:

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.

Treatment:

Device: Endoscopic biliary transmural drainage

2- Biliary LAMS plus Doublu-Pigtail plastic Etent

Description:

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.

Treatment:

Device: Endoscopic biliary transmural drainage