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Clinical Trials/NCT04420039
NCT04420039
Completed
Not Applicable

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

Hospital Universitari de Bellvitge3 sites in 1 country39 target enrollmentMay 2015
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ConditionsPancreatic CancerEndoscopyOncologic DisordersTherapy Related Neoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Hospital Universitari de Bellvitge
Enrollment
39
Locations
3
Primary Endpoint
Potential benefits
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
March 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Universitari de Bellvitge
Responsible Party
Principal Investigator
Principal Investigator

Joan B Gornals

Programme Director, Endoscopy Area, MD, PhD

Hospital Universitari de Bellvitge

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Potential benefits

Time Frame: 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 Outcomes

  • Technical success(24 hours)
  • Clinical success(4 weeks)
  • Procedure time(2 hours)
  • Biliary reintervention(6 months)

Study Sites (3)

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