Plastic Stent Within A Lumen-Apposing Stent For Malignant Biliary Obstruction

Study Overview

Plastic Stent Within a Lumen-Apposing Stent for 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.

N/A

Pancreatic Cancer
Endoscopy
Oncologic Disorders
Therapy Related Neoplasms

DEVICE: Endoscopic biliary transmural drainage

HUBellvitge

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-06-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-07-11
First Submitted that Met QC Criteria 2020-06-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-07-13
First Posted (ACTUAL) 2020-06-09	Results First Posted N/A	Last Verified 2021-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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
: 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

Participant Group/Arm

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

: 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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Consecutive unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla

Borderline cancer cases
Others type of biliary stents
Severe coagulopathy or thrombocytopenia.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Hospital Mutua de Terrassa
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Institut d'Investigació Biomèdica de Bellvitge

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record