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Completed

NCT Number: NCT05556668

Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.

To assess safety and effectiveness in the long term of percutaneous insertion of Biodegradable (BD) Biliary Stents for the treatment of benign biliary strictures, in a single center experience.

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Key information

Conditions

Biliary Stricture Bile Duct Injury Bile Duct Stricture Biliary Tract Diseases Digestive System Diseases Hyperbilirubinemia Jaundice Jaundice, Obstructive Obstructive Jaundice Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Stents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Parc Tauli Sabadell

Sabadell, 08208, Spain

About this study

This is an observational study (retrospective analysis on a prospective database) of patients that have been implanted a biodegradable stent in the biliary tree to treat benign stenosis.

From march 2011 until May 2020, a prospective collection of clinical data has been conducted in patients with symptomatic benign biliary strictures treated biodegradable polydioxanone stents. A strict follow-up protocol has been carried out according to standard practice (at 2, 4, 6 months and every 6 months up to 5 years). Once the follow-up is completed, the collected data will be analyzed, assessing the long term effectiveness and safety, but also other variables related to stent implantation and impact on patient's quality of life.

A subgroup analysis of anastomotic biliary strictures will be performed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients over 18 years old attended in the interventional radiology department for the implantation of a biodegradable biliary stent (BBS: ELLA-CS, Hradec Kralove, Czech Republic), for each stenosis, by percutaneous technique.
  • Written informed consent given

Exclusion criteria

  • Patients under 18 years old
  • Patients with post-liver transplant biliary strictures
  • Patients for whom no post-intervention follow-up data are available
  • Patients in whom malignancy is demonstrated as a cause of the stricture after stent placement.

Treatment and study plan

Percutaneous placement of biodegradable biliary stents

Device

Benign biliary strictures treated with polydioxanone (PPDX) stents (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography. Before stent implantation, balloon bilioplasty is be performed.

Primary outcomes

  1. Stent Primary Patency

    Time frame: Time from stent implantation to new intervention due to restenosis or occlusion detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests), assessed up to 60 months

    Time until new intervention due to re-stenosis or occlusion (detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests)

  2. Adverse Events

    Time frame: From stent implantation to completion of follow-up, up to 5 years

    Major and minor complications. The Clavien-Dindo classification will be used for grading the severity of complications.

Secondary outcomes

  1. Technical Success

    Time frame: Immediate (during procedure)

    To correctly deploy a biodegradable stent using a percutaneous approach covering the stricture with a residual stenosis of less than 30% of the lumen, and correct flow of contrast through it into the intestinal lumen

  2. Length of Hospital Stay

    Time frame: nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days

    number of days that patients spend in hospital to have the stent inserted, including a 24-48h control cholangiogram

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Universitat Autonoma de Barcelona

Registry information

Official study title

Role of Biodegradable Polydioxanone Biliary Stents for the Percutaneous Treatment of Benign Biliary Strictures.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2022
Registry last updated
Mar 1, 2023

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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