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

Pancreatic Cancer Clinical Trial

— LAMSpigBil  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420039
• Other study ID #: HUBellvitge
• Status: Completed
• Start date: May 2015
• Est. completion date: March 2021

Study information

• Verified date: July 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2021
• Est. primary completion date: September 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopy
• Neoplasms, Second Primary
• Oncologic Disorders
• Pancreatic Cancer
• Therapy Related Neoplasms

Intervention

Device:
• Endoscopic 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.

Locations

Country	Name	City	State
Spain	Hospital de Sant Pau i de la Santa Creu	Barcelona	Catalonia
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitari Mútua de Terrassa	Terrassa	Barcelona, Catalonia

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Mutua de Terrassa, Institut d'Investigació Biomèdica de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Procedure time	Procedure time was defined from the insertion of the endoscope to its removal.	2 hours
Secondary	Biliary reintervention	Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.	6 months