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Biliary Tract DiseasesNCT02353286

Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent

A study testing Endoscopic insertion of biodegradable biliary stent in people with Biliary Tract Diseases, run by Tampere University Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with either post-cholecystectomy bile leak or benign biliary stricture are recruited for endoscopic insertion of a biodegradable biliary stent. A follow-up of 12 months with repeated serum samples and magnetic resonance imaging is scheduled. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Biliary Tract Diseases
What is being tested?
Endoscopic insertion of biodegradable biliary stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteFinland
Study dates
May 2014to 31 Dec 2017
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • informed-consent patients with diagnosed or suspected post-cholecystectomy biliary leak or benign biliary stricture.

Who cannot join

  • Patients with contra-indications for magnetic resonance imaging (MRI) or surgically altered gastro-duodenal anatomy (e.g. roux-y-loop) are excluded from the study.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Tampere University Hospital, Dept. of Gastroenterology and Alimentary Tract Surgery

    Tampere, 33521

Other trials in Finland

About this study

Official title: Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Polydioxanone Biliary Stent

Patients with either post-cholecystectomy bile leak or benign biliary stricture are recruited for endoscopic insertion of a biodegradable biliary stent. A follow-up of 12 months with repeated serum samples and magnetic resonance imaging is scheduled. The primary end points are feasibility of endoscopic insertion with the novel implantation device and stricture or leak resolution as well as clinical treatment success.

Read the detailed description

Benign biliary strictures (BBS) and post-cholecystectomy bile leaks have traditionally been treated endoscopically with plastic stents. In BBS, promising results of covered self-expanding metal stent use have been recently published. However, in both BBS and post-cholecystectomy bile leak the need of stent therapy is temporary and endoscopic stent exchange or removal is unavoidable. These two groups of patients may be the ones that would most obviously benefit from biodegradable (BD) biliary stents. Studies of BD stents on animal models have shown excellent long term patency and safety both in biliary and pancreatic duct as well better outcome compared to plastic stents after post-cholecystectomy bile leak in an animal study. Until recently, non-operative insertion of BD polydioxanone stent in human biliary tract has been possible only via percutaneous route.

With the novel implantation device, the BD stents (braided, self-expanding polydioxanone stent, 8 x 40-60mm, Ella, Czech republic) may be used endoscopically during endoscopic retrograde cholangio-pancreatography (ERCP).

The hypothesis is that larger diameter and radial expansion strength provide at least similar treatment success as the current method of endoscopic insertion of plastic or covered self-expanding metal stents in bile leak and BBS, respectively. However, later stent exchange or removal is not necessary with BD stents.

Being tested
Endoscopic insertion of biodegradable biliary stent
Keywords
Biodegradable stents, ERCP
Medical subject headings
Biliary Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic insertion of biodegradable biliary stentDevice

    Also called Braided, self-expanding polydioxanone stent, Ella, Czech Rep

    Endoscopic insertion of biodegradable biliary stent

Study groups in NCT02353286
Study groupRoleWhat they receive
Post-cholecystecomy bile leakExperimentalEndoscopic insertion of biodegradable biliary stent
Receives: Device: Endoscopic insertion of biodegradable biliary stent
Benign biliary strictureExperimentalEndoscopic insertion of biodegradable biliary stent
Receives: Device: Endoscopic insertion of biodegradable biliary stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical treatment success of stricture or leakage, treatment failure rate measured by change in treatment protocol or unplanned interventions, radiologic stricture diameter in MRI, radiologic stent degradation in MRI

    Stent patency, unplanned admissions and interventions, signs of cholangitis during treatment assessed by repeated liver function tests, magnetic resonance imaging and interview. Change in stent diameter and gradual radiologic dissappearance due to degradation assessed by repeated MRI and liver function tests, stricture resolution assessed by repeated MRI and radiologic measurement of stricture width as well as liver function tests, leakage resolution assessed by disappearance of biliary fluid collection in MRI and liver function tests

    Measured: The follow-up of 12 months after stent implantation

Secondary outcomes (2)

  1. ERCP complications, late adverse events during stent therapy

    endoscopic retrograde cholangio-pancreatography (ERCP) and stent implantation related complications graded mild-moderate-severe according to Cotton et al 1991, unplanned admissions and incidence of late adverse events such as acute cholangitis until up to 12 months of follow-up assessed by repeated MRI, phone interview, blood samples and review of patient records at each follow-up contact.

    Measured: 30 days from stent implantation, late adverse events up to 12 months

  2. Technical success of stent insertion

    To assess the usefulness and safety of a novel endoscopic implantation device measured by success rate of stent implantation and evaluation possible intra-procedural technical challenges during ERCP

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2015 (estimated)
  2. Study startMay 2014
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02353286
Sponsor's protocol ID
Biodegradable Biliary stent
Status last verified
May 2018
First submitted
16 Jan 2015
Last updated
14 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Mauri G, Michelozzi C, Melchiorre F, Poretti D, Tramarin M, Pedicini V, Solbiati L, Cornalba G, Sconfienza LM. Biodegradable biliary stent implantation in the treatment of benign bilioplastic-refractory biliary strictures: preliminary experience. Eur Radiol. 2013 Dec;23(12):3304-10. doi: 10.1007/s00330-013-2947-2. Epub 2013 Jul 11.

    PubMed 23842947

  • Laukkarinen J, Nordback I, Mikkonen J, Karkkainen P, Sand J. A novel biodegradable biliary stent in the endoscopic treatment of cystic-duct leakage after cholecystectomy. Gastrointest Endosc. 2007 Jun;65(7):1063-8. doi: 10.1016/j.gie.2006.11.059.

    PubMed 17531643

  • Grolich T, Crha M, Novotny L, Kala Z, Hep A, Necas A, Hlavsa J, Mitas L, Misik J. Self-expandable biodegradable biliary stents in porcine model. J Surg Res. 2015 Feb;193(2):606-12. doi: 10.1016/j.jss.2014.08.006. Epub 2014 Aug 9.

    PubMed 25201575

  • Lorenzo-Zuniga V, Moreno-de-Vega V, Marin I, Boix J. Biodegradable stents in gastrointestinal endoscopy. World J Gastroenterol. 2014 Mar 7;20(9):2212-7. doi: 10.3748/wjg.v20.i9.2212.

    PubMed 24605020

  • Siiki A, Rinta-Kiikka I, Sand J, Laukkarinen J. A pilot study of endoscopically inserted biodegradable biliary stents in the treatment of benign biliary strictures and cystic duct leaks. Gastrointest Endosc. 2018 Apr;87(4):1132-1137. doi: 10.1016/j.gie.2017.10.042. Epub 2017 Nov 8.

    PubMed 29128386

  • Siiki A, Rinta-Kiikka I, Sand J, Laukkarinen J. Biodegradable biliary stent in the endoscopic treatment of cystic duct leak after cholecystectomy: the first case report and review of literature. J Laparoendosc Adv Surg Tech A. 2015 May;25(5):419-22. doi: 10.1089/lap.2015.0068. Epub 2015 Apr 8.

    PubMed 25853929

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic insertion of biodegradable biliary stent in people with Biliary Tract Diseases, run by Tampere University Hospital at 1 site in Finland.

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 1 inclusion and 1 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 14 May 2018. 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 Finland. 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?

Clinical treatment success of stricture or leakage, treatment failure rate measured by change in treatment protocol or unplanned interventions, radiologic stricture diameter in MRI, radiologic stent degradation in MRI (time frame: The follow-up of 12 months after stent implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02353286, which also lists 6 linked publications.

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 14 May 2018.

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