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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Endoscopy; Oncologic Disorders; Therapy Related Neoplasms
• Intervention / Treatment: Device: Endoscopic biliary transmural drainage

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Barcelona, Catalonia
    • Terrassa, Barcelona, Catalonia, Spain, 08221
      • Hospital Universitari Mutua de Terrassa
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Hospital de Sant Pau i de la Santa Creu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Palliative malignant biliopancreatic pathology

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1- Single biliary LAMS; 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; 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.; Other Names: Endoscopic Ultrasound-guided biliary drainage; Choledochoduodenostomy
2- Biliary LAMS plus Doublu-Pigtail plastic Etent; 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; 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.; Other Names: Endoscopic Ultrasound-guided biliary drainage; Choledochoduodenostomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Institut d'Investigació Biomèdica de Bellvitge; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Hospital Mutua de Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Endoscopic Ultrasound; Malignant biliary obstrucction; Therapeutic endoscopy; Biliary drainage; Lumen apposing stent; Pancreatic neoplasm
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms, Second Primary
• Other Study ID Numbers: HUBellvitge

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes