NCT03763214

Brief Summary

In this randomized trial two two self-expanding metal stents (SEMS) for treatment of malignant biliary strictures are investigated. A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard covered metal stents. PFTE (Teflon) coating promises improved formability over standard silicone-coated stents, easier removal through the soft surface, and significantly reduced tumor growth through the impermeable surface.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

May 14, 2018

Last Update Submit

December 1, 2018

Conditions

Bile Duct StrictureBile Duct CancerPancreas Cancer

Keywords

metal stentbiliary stricturestenting

Outcome Measures

Primary Outcomes (1)

  • Stent migration

    Rate of stent migrations

    12 month

Secondary Outcomes (3)

  • Stent dysfunction (re-stenosis)

    12 month

  • Number of ERCPs in one year

    12 month

  • Survival rate

    12 month

Study Arms (2)

Stenting with PTFE-coated stent (HILZO)

EXPERIMENTAL

The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow

Device: Stenting with PTFE-coated stent (HILZO)

Stenting standard silicone coated stent

ACTIVE COMPARATOR

The bile duct is stented with a standard silicone-coated stent by duodenoscopy to allow bile duct flow

Device: Stenting with PTFE-coated stent (HILZO)

Interventions

Stenting with PTFE-coated stent (HILZO)DEVICE

Placing a metal stent in the biliary tract by duodenoscopy

Stenting standard silicone coated stentStenting with PTFE-coated stent (HILZO)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for the palliative metal-stent system for malignant stenosis of the distal DHC (bile duct tumors, pancreatic carcinoma, papillary carcinoma, lymphoma, lymph node metastases in the hilum)

You may not qualify if:

  • Age under 18 years
  • Pregnancy
  • Contraindication to an endoscopic examination
  • Life expectancy under 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der J. W. Goethe-Universität

Frankfurt am Main, 60590, Germany

RECRUITING

MeSH Terms

Conditions

Bile Duct NeoplasmsPancreatic Neoplasms

Interventions

Stents

Condition Hierarchy (Ancestors)

Biliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Central Study Contacts

Mireen Friedrich-Rust, Prof.

CONTACT

069-6301-0mireen.friedrich-rust@kgu.de

Fabian Finkelmeier, Dr.

CONTACT

069-6301-0fabian.finkelmeier@kgu.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, two arms
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Record Keeper, Clinical Professor

Study Record Dates

First Submitted

May 14, 2018

First Posted

December 4, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2020

Study Completion

September 1, 2020

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

DE(1)