Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out

Stent Clinical Trial

Official title:

Randomized Trial of Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03534362
• Other study ID #: 28525
• Status: Terminated
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: September 23, 2019

Study information

• Verified date: April 2020
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgery on the frontal sinus is done for patients who have sinus problems that do not respond to medications. It involves making an opening within the right and left frontal sinus of the nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the left and right sinuses become one large sinus. This is done with sharp instruments and rigid endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or steroids or both may be used to try to help make sure that the opening does not close back up. Two current options for this are Propel stents and steroid-soaked Nasopore. Propel stents are FDA-approved. Nasopore and Kenalog injection are both FDA-approved, but their use together is part of the study and not specifically FDA-approved. A previous study shows that Propel stents are useful to reduce scarring in other frontal sinus procedures. We would like to know whether this is true in larger frontal sinus surgery where one common cavity is made and whether both steroid-containing stents are the same.

Description:

Endoscopic sinus surgery is commonly used to manage chronic inflammatory frontal sinus disease that is not adequately controlled with medical therapy alone. In recalcitrant cases, a more extensive procedure called the modified endoscopic Lothrop procedure or frontal drill-out (FDO) procedure is often performed. The frontal drill-out procedure is performed endoscopically and its goal is to create one large common cavity between the left and right frontal sinuses and nasal cavities to allow adequate drainage and communication for subsequent drug delivery through sinonasal irrigations if indicated. Failure of this procedure is most commonly the results of re-stenosis of the outflow tract due to scarring, adhesions, or progressive disease such as polyposis. One meta analysis assessing the long-term complications of frontal drillouts reported an overall failure rate to be 13.9%, defined as those individuals needing further surgery. Another clinical trial reported a failure rate for a 200-person study to be 30%.

Placing a steroid-eluding biodegradable stent into the sinonasal cavities after surgery is thought to reduce the occurrence of re-stenosis, both by physically stenting the opening and by treating resultant inflammation with corticosteroid. Propel stents are made of synthetic dissolvable polymer that contains a corticosteroid (mometasone furoate) and has been FDA-approved to stent and reduce inflammation over 30 days. Similarly, Nasopore is an FDA-approved fragmentable nasal dressing that is used as a stent. Kenalog soaking the Nasopore is thought to act as the functional equivalent of the mometasone furoate found in the Propel stent, but this use is investigational. The effect of stenting and its consequences on the outcomes of FDO specifically has also not been well studied.Recent randomized-controlled trial of Propel stent placement after frontal sinusotomy (a less extensive form of frontal sinus surgery compared to FDO procedure) showed improvement in outcomes compared to no stent placement and no major complications.There are no known randomized-controlled trials to date of propel stent placement or Nasopore-soaked Kenalog placement after FDO procedure. We wish, therefore, to perform a randomized trial to compare the efficacy and outcomes of Nasopore-soaked kenalog versus propel stenting.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 23, 2019
• Est. primary completion date: September 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients able to speak and understand English

• Patients for whom frontal drill out procedure is medically indicated

Exclusion Criteria:

• Patients who are cognitively impaired and unable to consent

• Patients who are not candidates for Frontal Drill out

• Patients with contraindications to PROPEL Mini sinus implant or Kenalog soaked nasopore: known hypersensitivity to mometasone furoate, Kenalog, lactide, glycolide or caprolactone copolymers

• Non-English speaking patients

Related Conditions & MeSH terms

• Frontal Sinusitis
• Sinusitis
• Sinusitis, Frontal
• Stent

Intervention

Device:
• Nasopore
Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract
• Propel
Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.

Locations

Country	Name	City	State
United States	Saint Louis Universtiy	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

References & Publications (9)

Anderson P, Sindwani R. Safety and efficacy of the endoscopic modified Lothrop procedure: a systematic review and meta-analysis. Laryngoscope. 2009 Sep;119(9):1828-33. doi: 10.1002/lary.20565. Review. — View Citation

Eloy P, Vlaminck S, Jorissen M, Hellings P, Timmermans M, Daele J, Ransky P, Hassid S, Van Zele T, Bachert C, Poirrier AL, Bertrand B. Type III frontal sinusotomy: surgical technique, indications, outcomes, a multi-university retrospective study of 120 cases. B-ENT. 2011;7 Suppl 17:3-13. — View Citation

Gross CW, Harrison SE. The modified Lothrop procedure: indications, results, and complications. Otolaryngol Clin North Am. 2001 Feb;34(1):133-7. Review. — View Citation

Hoyt WH 3rd. Endoscopic stenting of nasofrontal communication in frontal sinus disease. Ear Nose Throat J. 1993 Sep;72(9):596-7. — View Citation

Huang Z, Hwang P, Sun Y, Zhou B. Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database Syst Rev. 2015 Jun 10;(6):CD010436. doi: 10.1002/14651858.CD010436.pub2. Review. — View Citation

Hunter B, Silva S, Youngs R, Saeed A, Varadarajan V. Long-term stenting for chronic frontal sinus disease: case series and literature review. J Laryngol Otol. 2010 Nov;124(11):1216-22. doi: 10.1017/S0022215110001052. Epub 2010 May 20. Review. — View Citation

Smith TL, Singh A, Luong A, Ow RA, Shotts SD, Sautter NB, Han JK, Stambaugh J, Raman A. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016 Dec;126(12):2659-2664. doi: 10.1002/lary.26140. Epub 2016 Jul 1. Erratum in: Laryngoscope. 2020 Mar;130(3):836. — View Citation

Ting JY, Wu A, Metson R. Frontal sinus drillout (modified Lothrop procedure): long-term results in 204 patients. Laryngoscope. 2014 May;124(5):1066-70. doi: 10.1002/lary.24422. Epub 2013 Nov 13. — View Citation

Weber RK, Hosemann W. Comprehensive review on endonasal endoscopic sinus surgery. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2015 Dec 22;14:Doc08. doi: 10.3205/cto000123. eCollection 2015. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline of Sino-Nasla Outcome Test (SNOT-22) Scores	To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups.	After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.
Secondary	Surgical Postoperative Complications, Devices	To compare the incidence of other surgical postoperative complications (diagnosed post-operative cerebrospinal fluid (CSF) leak, epistaxis requiring treatment, adhesions) between Propel stent and Nasopore.	After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.
Secondary	Surgical Postoperative Complications, Frontal Sinus Pathology	To ascertain the incidence of surgical complications based on the specific frontal sinus pathology.	After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.