Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 5/25/2018 |
| Start Date: | April 13, 2018 |
| End Date: | December 31, 2022 |
Randomized Trial of Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out
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.
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
