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

Biliary Tract Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353286
• Other study ID #: Biodegradable Biliary stent
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Diseases

Intervention

Device:
• Endoscopic insertion of biodegradable biliary stent
Endoscopic insertion of biodegradable biliary stent

Locations

Country	Name	City	State
Finland	Tampere University Hospital, Dept. of Gastroenterology and Alimentary Tract Surgery	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (4)

Grolich T, Crha M, Novotný L, Kala Z, Hep A, Necas A, Hlavsa J, Mitáš L, Misík 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. — View Citation

Laukkarinen J, Nordback I, Mikkonen J, Kärkkäinen 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. — View Citation

Lorenzo-Zúñiga V, Moreno-de-Vega V, Marín 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The follow-up of 12 months after stent implantation
Secondary	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.	30 days from stent implantation, late adverse events up to 12 months
Secondary	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	intraoperative