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OpenTrials
Completed

NCT Number: NCT04420039

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endoscopy Neoplasms Neoplasms by Site Neoplasms, Second Primary Oncologic Disorders Pancreatic Diseases Pancreatic Neoplasms Therapy Related Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic biliary transmural drainage

Device

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

Primary outcomes

  1. 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

  1. Technical success

    Time frame: 24 hours

    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

  2. Clinical success

    Time frame: 4 weeks

    Clinical success was defined as a reduction in bilirubin by 50% at 2-weeks after stent placement, meaning that the biliary stent was functional.

  3. Procedure time

    Time frame: 2 hours

    Procedure time was defined from the insertion of the endoscope to its removal.

  4. Biliary reintervention

    Time frame: 6 months

    Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Collaborators

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

Registry information

Official study title

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

Acronym: LAMSpigBil

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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