Comparison Between Winged Versus Traditional Plastic Stents for Biliary Drainage

University of Leipzig

Status: Completed

Conditions: Bile Duct Stones; Biliary Tract Cancer; Biliary Obstruction

Treatments: Device: Standard plastic stents; Device: Winged plastic stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06960733

Viaduct-ERCP

Details and patient eligibility

About

This study was randomized, controlled, blinded trial with a two-arm parallel-group design to directly compare the therapeutic outcomes of winged versus conventional stents in patients with benign or malignant biliopancreatic conditions requiring ERCP and subsequent insertion or replacement of plastic stents.

Full description

Procedure The study was structured as a randomized, controlled trial using a two-arm parallel group design to compare different therapies (winged stent vs. conventional stent). Randomization was carried out in a 1:1 ratio using block randomization. Upon stent exchange, participants were switched to the alternate treatment group. Each subject was intended to receive both forms of therapy over the course of the treatment periods in a crossover design, with only the sequence of therapies being determined randomly (Figure 1).

The procedures were conducted using standard techniques. No additional steps, biopsies, or similar procedures were required. For the ERCPs carried out in the Endoscopy Department of the University Hospital Leipzig, Fujifilm video duodenoscopes were utilized

Data On the procedure date, we gathered essential baseline and procedural information including demographic data (age and gender), previous stent interventions, diagnostic imaging and laboratory results, specifics of the stent used (type, diameter, and length), the effectiveness of the stent insertion, and any associated complications.

Beyond standard care, follow-up was conducted at intervals of one week, one month, and two months post-intervention, utilizing a methodical questionnaire to monitor clinical progress and evaluate for any stent-related dysfunction."

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biliopancreatic disorder requiring plaxtic biliary stent therapy
• written informed consent

Exclusion criteria

• Pregnancy
• Breastfeeding
• Live Expectancy of less than one month
• Biliary drainage by metal stent or external drainage.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Conventional Stenting

Active Comparator group

Description:

Stenting of biliary tract by standard plastic stent. Change of stent-type at regular stent exchange after three months (from winged to standard and vice versae).

Treatment:

Device: Winged plastic stent

Device: Standard plastic stents

Winged Stent

Experimental group

Description:

Stenting of biliary tract by use of winged-design stent. Change of stent-type at regular stent exchange after three months (from winged to standard and vice versae).

Treatment:

Device: Winged plastic stent

Device: Standard plastic stents