NCT04420039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

5.3 years

First QC Date

June 1, 2020

Last Update Submit

July 11, 2021

Conditions

Pancreatic CancerEndoscopyOncologic DisordersTherapy Related Neoplasms

Keywords

Malignant biliary obstrucctionTherapeutic endoscopyBiliary drainageLumen apposing stentEndoscopic UltrasoundPancreatic neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Technical success

    24 hours

  • Clinical success

    4 weeks

  • Procedure time

    2 hours

  • Biliary reintervention

    6 months

Study Arms (2)

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

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

Interventions

Endoscopic biliary transmural drainageDEVICE

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.

Also known as: Endoscopic Ultrasound-guided biliary drainage, Choledochoduodenostomy
1- Single biliary LAMS2- Biliary LAMS plus Doublu-Pigtail plastic Etent

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Palliative malignant biliopancreatic pathology

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Catalonia, 08221, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital de Sant Pau i de la Santa Creu

Barcelona, Catalonia, 08041, Spain

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasms, Second Primary

Interventions

Choledochostomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeBiliary Tract Surgical ProceduresDigestive System Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Programme Director, Endoscopy Area, MD, PhD

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 9, 2020

Study Start

May 1, 2015

Primary Completion

September 1, 2020

Study Completion

March 1, 2021

Last Updated

July 13, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)