NCT04115696

Brief Summary

Spanish registry of resorbable stent implantation in biliary benign strictures. This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain). A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 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

March 1, 2012

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

5.9 years

First QC Date

September 12, 2018

Last Update Submit

October 7, 2019

Conditions

Biliary TractBiliary Tract DiseasesStenosisFollow-Up StudiesStents

Outcome Measures

Primary Outcomes (2)

  • Biliary duct patency: bilirubin alterations (> 2.2)

    Biliary duct patency after stent implantation evaluating bilirubin alterations

    24 months

  • Stent reabsorption: radiographic persistence of stent radiopaque marks

    Radiography

    12 months

Interventions

Percutaneous placement of biodegradable biliary stentsDEVICE

The bening biliary strictures stents used in this register are made of polydioxanone (PPDX) (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography using the standard micropuncture technique. Before stent implantation, balloon bilioplasty may be performed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

120- 150 patients

You may qualify if:

  • Older than 18 years-old
  • Informed consent
  • Non-lithiasic chronic bening single or multiple stenosis
  • Possibility of follow-up plus 1 year

You may not qualify if:

  • Under 18 years old
  • Unsigned consent
  • Non treatable coagulopathy
  • Acute signs of infection
  • Diagnosis of neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lozano Blesa Universitary Hospital

Zaragoza, Aragon, 50009, Spain

Location

Hospital Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Biliary Tract DiseasesConstriction, Pathologic

Condition Hierarchy (Ancestors)

Digestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2018

First Posted

October 4, 2019

Study Start

March 1, 2012

Primary Completion

February 3, 2018

Study Completion

July 4, 2019

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations

ES(2)