Clinical trial NCT02353286: Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Biliary Stent
Official title: Endoscopic Treatment of Benign Biliary Strictures and Cystic Duct Leakages With a Novel Biodegradable Polydioxanone Biliary Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract Diseases
Keywords: Biodegradable stents, ERCP
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
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
timeFrame: The follow-up of 12 months after stent implantation
Secondary outcomes:
measure: ERCP complications, late adverse events during stent therapy
timeFrame: 30 days from stent implantation, late adverse events up to 12 months
measure: Technical success of stent insertion
timeFrame: intraoperative
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital, Dept. of Gastroenterology and Alimentary Tract Surgery
Study officials:
affiliation: Dept. of Gastroenterology and Alimentary Tract Surgery
name: Johanna Laukkarinen, Md, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Gastroenterology and Alimentary Tract Surgery
name: Juhani Sand, Md, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.