Biodegradable Stents in the Management of Stenoses of the Large Airways

• ClinicalTrials.gov Identifier: NCT02620319
• Recruitment Status: Unknown
• First Posted: December 3, 2015
• Last Update Posted: June 17, 2016
• Sponsor: Ludek Stehlik
• Collaborators: Ministry of Health, Czech Republic; University Hospital Olomouc; University Hospital, Motol
• Information provided by (Responsible Party): Ludek Stehlik, Thomayerova Teaching Hospital

Study Description

Brief Summary:

The objective of this project is to determine whether biodegradable polydioxanone stents are efficient in the treatment of adult patients with tracheobronchial stenoses.

Condition or disease	Intervention/treatment	Phase
Tracheal Stenosis	Device: SX-ELLA Stent DV Tracheal (DV Stent)	Not Applicable

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Biodegradable Stents in the Management of Stenoses of the Large Airways
• Study Start Date: May 2013
• Estimated Primary Completion Date: December 2016
• Estimated Study Completion Date: December 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: biodegradable stent; endoscopic implantation of biodegradable airway stent, the SX-ELLA Stent DV Tracheal (DV Stent)

Device: SX-ELLA Stent DV Tracheal (DV Stent); The trachea is intubated with a rigid bronchoscope while participants are placed under total intravenous anesthesia and jet ventilation. The delivery apparatus containing the stent is introduced through a rigid tube to the desired depth under visual control. Then the stent is deployed and its position is determined and, if necessary, stent is repositioned using rigid forceps. In-stent balloon dilation is carried out. If needed, thoracic surgeon can secure the stent in place via external (percutaneous) fixation: one suture is passed through the stent, the tracheal wall, soft tissues, and skin; the suture is then knotted on the skin of the neck. The suture is removed two to three weeks after implantation.; Other Name: DV Stent

Outcome Measures

Primary Outcome Measures :

1. airway patency during the presence of the stent in the airways [ Time Frame: residence time of the stent in the airways, i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support ]
   Scheduled bronchoscopies, trachea is, for the purposes of the study, classified according to Freitag's recommended adapted classification system (Freitag L. et al. A proposed classification system of central airway stenosis, Eur Respir J 2007; 30:7-12).

Secondary Outcome Measures :

1. number of complications: infection, bleeding, migration, obstructive granulation tissue formation, sudden restenosis (of any origin, unexpected in relation to the degree of the stent degradation) [ Time Frame: residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter ]
2. evaluation of forced expiratory volume in 1 second (FEV1) [ Time Frame: residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter ]
   FEV1 (in liters and % predicted values) measurements within follow-ups.
3. evaluation of forced vital capacity (FVC) [ Time Frame: residence time of the stent in the airways (i.e. as long as no stent material is found, up to 180 days after implantation, since then the stent is not considered to provide any mechanical support) and 6 months thereafter ]
   FVC (in liters and % predicted values) measurements within follow-ups.
4. airway patency after complete degradation of the stent or loss of majority support functions [ Time Frame: six months, beginning after identifying the complete degradation of the stent or 180 days after implantation ]
   Scheduled bronchoscopies, trachea is, for the purposes of the study, classified according to Freitag's recommended adapted classification system (Freitag L. et al. A proposed classification system of central airway stenosis, Eur Respir J 2007; 30:7-12).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• significant large airway stenoses
• benign tracheobronchial stenosis of any origin in participants who can not go for surgery, or who refuse surgical treatment
• benign tracheobronchial stenoses of any origin when the surgery is planed after some delay, benign tracheobronchial stenoses when the effect of anti- inflammatory or anti-infective treatment is expected
• malignant tracheobronchial stenoses due to extrinsic compression when exhausted curative modalities
• malignant stenoses from extrinsic compression in participants undergoing the actinotherapy or receiving systemic anticancer therapy

Exclusion Criteria:

• stenoses of any origin which can be treated primarily surgically
• stenoses caused by intraluminal growth of tumor, tracheoesophageal or bronchoesophageal fistulas
• pregnancy

Contacts and Locations

Locations

Czech Republic

Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc

Olomouc, Czech Republic, 779 00

Department of Respiratory Medicine, Thomayer Hospital

Prague, Czech Republic, 140 59

Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital

Prague, Czech Republic, 150 06

Sponsors and Collaborators

Ludek Stehlik

Ministry of Health, Czech Republic

University Hospital Olomouc

University Hospital, Motol

Investigators

• Principal Investigator: Ludek Stehlik, MUDr.; Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4
• Study Director: Miloslav Marel, Prof. MUDr.; Department of Pneumology, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital
• Study Director: Vitezslav Kolek, Prof. MUDr.; Department of Respiratory Diseases and Tuberculosis, University Hospital Olomouc
• Study Director: Martina Vasakova, Prof. MUDr.; Department of Respiratory Medicine, Thomayer Hospital, Videnska 800, 140 59 Praha 4

More Information

Publications of Results:

Hytych V, Horazdovsky P, Stehlik L, Pracharova S, Pohnan R, Lefnerova S, Vasakova M. Our own method of fixation of biodegradable tracheal stent. Bratisl Lek Listy. 2015;116(5):340-2.

Stehlik L, Hytych V, Letackova J, Kubena P, Vasakova M. Biodegradable polydioxanone stents in the treatment of adult patients with tracheal narrowing. BMC Pulm Med. 2015 Dec 21;15:164. doi: 10.1186/s12890-015-0160-6.

Other Publications:

Novotny L, Crha M, Rauser P, Hep A, Misik J, Necas A, Vondrys D. Novel biodegradable polydioxanone stents in a rabbit airway model. J Thorac Cardiovasc Surg. 2012 Feb;143(2):437-44. doi: 10.1016/j.jtcvs.2011.08.002. Epub 2011 Aug 31.

Lischke R, Pozniak J, Vondrys D, Elliott MJ. Novel biodegradable stents in the treatment of bronchial stenosis after lung transplantation. Eur J Cardiothorac Surg. 2011 Sep;40(3):619-24. doi: 10.1016/j.ejcts.2010.12.047. Epub 2011 Feb 21.

Vondrys D, Elliott MJ, McLaren CA, Noctor C, Roebuck DJ. First experience with biodegradable airway stents in children. Ann Thorac Surg. 2011 Nov;92(5):1870-4. doi: 10.1016/j.athoracsur.2011.07.042. Epub 2011 Oct 31.

Chin CS, Litle V, Yun J, Weiser T, Swanson SJ. Airway stents. Ann Thorac Surg. 2008 Feb;85(2):S792-6. doi: 10.1016/j.athoracsur.2007.11.051. Review.

Korpela A, Aarnio P, Sariola H, Törmälä P, Harjula A. Bioabsorbable self-reinforced poly-L-lactide, metallic, and silicone stents in the management of experimental tracheal stenosis. Chest. 1999 Feb;115(2):490-5.

Korpela A, Aarnio P, Sariola H, Törmälä P, Harjula A. Comparison of tissue reactions in the tracheal mucosa surrounding a bioabsorbable and silicone airway stents. Ann Thorac Surg. 1998 Nov;66(5):1772-6.

Saito Y, Minami K, Kobayashi M, Nakao Y, Omiya H, Imamura H, Sakaida N, Okamura A. New tubular bioabsorbable knitted airway stent: biocompatibility and mechanical strength. J Thorac Cardiovasc Surg. 2002 Jan;123(1):161-7.

Freitag L, Ernst A, Unger M, Kovitz K, Marquette CH. A proposed classification system of central airway stenosis. Eur Respir J. 2007 Jul;30(1):7-12. Epub 2007 Mar 28.

• Responsible Party: Ludek Stehlik, MUDr., Thomayerova Teaching Hospital
• ClinicalTrials.gov Identifier: NCT02620319 History of Changes
• Other Study ID Numbers: NT 14146-3/2013; NT14146 ( Other Grant/Funding Number: Internal Grant Agency of the Czech Ministry of Health )
• First Posted: December 3, 2015
• Last Update Posted: June 17, 2016
• Last Verified: December 2015

Keywords provided by Ludek Stehlik, Thomayerova Teaching Hospital:

bronchoscopy; polydioxanone; absorbable implants; stents

Additional relevant MeSH terms:

Tracheal Stenosis; Constriction, Pathologic; Pathological Conditions, Anatomical; Tracheal Diseases; Respiratory Tract Diseases