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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04420039

Acronym

LAMSpigBil

Enrollment

Registered

2020-06-09

Start date

2015-05-31

Completion date

2021-03-31

Last updated

2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy, Oncologic Disorders, Pancreatic Cancer, Therapy Related Neoplasms

Keywords

Malignant biliary obstrucction, Therapeutic endoscopy, Biliary drainage, Lumen apposing stent, Endoscopic Ultrasound, Pancreatic neoplasm

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.

Interventions

DEVICEEndoscopic biliary transmural drainage

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Biliary reintervention	6 months	Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026