Biliary ObstructionNCT06960733
Comparison Between Winged Versus Traditional Plastic Stents for Biliary Drainage
A study testing Winged plastic stent and Standard plastic stents in people with Biliary Obstruction and Bile Duct Stones, run by University of Leipzig at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction, Bile Duct Stones, Biliary Tract Cancer
- What is being tested?
- Winged plastic stent and Standard plastic stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2011to 31 Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biliopancreatic disorder requiring plaxtic biliary stent therapy
- written informed consent
Who cannot join
- Pregnancy
- Breastfeeding
- Live Expectancy of less than one month
- Biliary drainage by metal stent or external drainage.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Leipzig Medical Center, Department of Gastroenterology
Leipzig, Saxony, 04103
About this study
Official title: Comparative Efficacy of Winged Versus Traditional Plastic Stents for Biliary Drainage in Benign and Malignant Obstructions: A Randomized Study
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.
Read the detailed 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."
- Conditions
- Biliary Obstruction, Bile Duct Stones, Biliary Tract Cancer
- Being tested
- Winged plastic stent, Standard plastic stents
- Keywords
- ERCP, Biliary obstruction, biliary stenting, plastic stent
- Medical subject headings
- Cholecystolithiasis, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winged plastic stentDevice
Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention winged stents were used.
Standard plastic stentsDevice
Patient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention standard plastic stents were used.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Stenting | Active comparator | 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). Receives: Device: Winged plastic stent; Device: Standard plastic stents |
| Winged Stent | Experimental | 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). Receives: Device: Winged plastic stent; Device: Standard plastic stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysfunction
Sign of dysfunction of biliary stenting (fever, pain, jaundice)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jun 2011
- Primary completion30 Apr 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albrecht Hoffmeister, Professor, Study chair, University of Leipzig Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960733
- Sponsor's protocol ID
- Viaduct-ERCP
- Status last verified
- Oct 2010
- First submitted
- 28 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Winged Versus Traditional Plastic Stents for Biliary Drainage in Benign and Malignant Obstructions: A Randomized Study
- ClinicalTrials.gov ID
- NCT06960733
- Acronym / sponsor ID
- Viaduct-ERCP
- Conditions
- Biliary Obstruction, Bile Duct Stones, Biliary Tract Cancer
- Keywords
- ERCP, Biliary obstruction, biliary stenting, plastic stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 30 Apr 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Stenting | Active comparator | Device: Winged plastic stent, Device: Standard plastic stentsStenting 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). |
| Winged Stent | Experimental | Device: Winged plastic stent, Device: Standard plastic stentsStenting 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biliopancreatic disorder requiring plaxtic biliary stent therapy
- written informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Breastfeeding
- Live Expectancy of less than one month
- Biliary drainage by metal stent or external drainage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Winged plastic stentPatient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention winged stents were used. | Device | Conventional Stenting, Winged Stent |
| Standard plastic stentsPatient with need for stenting of bile duct were randomised for kind of stents. Stents used were either standard plastic stents or stents with winged design. In this Intervention standard plastic stents were used. | Device | Conventional Stenting, Winged Stent |
Primary outcome
Dysfunction
Time frame: 3 Months
Sign of dysfunction of biliary stenting (fever, pain, jaundice)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albrecht Hoffmeister, Professor study chair
University of Leipzig Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Winged plastic stent and Standard plastic stents in people with Biliary Obstruction and Bile Duct Stones, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysfunction (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.