Pituitary TumourNCT03282058
Silastic Stent Study
A study testing Silastic Stent in people with Pituitary Tumour, run by University of British Columbia.
Trial summary
Endoscopic skull base surgery is a relatively new procedure that is now a standard of care for surgeries at the base of the skull; however there are no studies that examine the healing process of the nasal lining with the use of silastic (silicone) stents (or splints) that might be placed at the time of surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Tumour
- What is being tested?
- Silastic Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 4 Apr 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients undergoing trans-sphenoidal endoscopic pituitary surgery at their first post-operative appointment
Who cannot join
- patients with inflammatory sinus conditions
- patients having undergone extensive skull base reconstructions
- patients having received previous radiotherapy
About this study
Official title: The Effect of Silastic Stenting on Post-Operative Intra-Nasal Re-Mucosalization
Endoscopic skull base surgery is a relatively new procedure that is now a standard of care for surgeries at the base of the skull; however there are no studies that examine the healing process of the nasal lining with the use of silastic (silicone) stents (or splints) that might be placed at the time of surgery. While there is some evidence to suggest that the use of stents improves wound healing, the decision to use a stent or not is currently up to the preference of the surgeon. To investigate the impact of stents on post-surgical healing, the investigators at Vancouver General Hospital will compare patients undergoing trans-sphenoidal pituitary surgeries with septal flap reconstruction with the use of silastic stents to line the septal donor site, and compare their recovery to those who did not receive stents. The investigators hypothesize that the use of silastic stents in endonasal surgery increases the rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the patients experience after surgery. In this randomized control trial the investigators aim to recruit 26 (13 in each arm) study participants. The primary outcome is to determine the effect of silastic stunting on healing of the naso-septal flap donor site. This objective will be achieved by assessment of endoscopic photographs of healing tissue and histologic assessment of healing tissues. The secondary outcome involves questionnaires that measure the patient's subjective nasal symptoms prior to and following endoscopic skull based surgery. Total time commitment for the study participant is about 4 months across 4 study visits (all of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative follow up visit and 12 week post-operative follow up visit.
- Conditions
- Pituitary Tumour
- Being tested
- Silastic Stent
- Keywords
- Silastic Stenting, Trans-nasal Endoscopic Surgery, Post-operative Intra-nasal Re-mucosalization
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silastic StentDevice
The silastic stent is a splint made of silicone.
| Study group | Role | What they receive |
|---|---|---|
| Silastic Stent | Experimental | At the time of surgery, if the patient is identified in the "silastic stent" arm, dressing of the septal donor site with silastic stents will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely. Receives: Device: Silastic Stent |
| No Stent | No intervention | At the time of surgery, if the patient is identified in the "no silastic stent" arm, dressing of the septal donor site without the stent will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely - this is currently the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the effect of silastic stunting on gross level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
Visual assessment of endoscopic photographs of healing tissue.
Measured: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Determining the effect of silastic stunting on microscopic level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
Histologic assessment of healing tissues.
Measured: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective nasal symptoms following endoscopic skull based surgery.
Participants will fill out a quality of life questionnaire called Sino-Nasal Outcome Test (SNOT-22).
Measured: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective post-operative outcomes following endoscopic skull based surgery.
Participants will fill out a post-operative rating scale.
Measured: Total time approx. 4 months (post-operative follow up at 4 and 12 weeks)
Physician's evaluation of the effect of silastic stunting on nasa-septal flap donor sites following endoscopic skull based surgery.
Physician will fill out an outcome measures evaluation scale.
Measured: Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start4 Apr 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pituitary TumourStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in one of two groups (stent vs no stent).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Janjua, University of British Columbia
- Investigators
- Arif Janjua, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282058
- Sponsor's protocol ID
- H14-02101
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am. 2009 Oct;42(5):857-66, x. doi: 10.1016/j.otc.2009.07.001.
PubMed 19909864Cowin A, McIntosh D, Wormald PJ. Healing of wounds created in the nasal mucosa following endoscopic sinus surgery can be affected by different nasal packing materials. Primary Intention Vol. 10 No. 3 August 2002.
Gamoletti R, Lanzarini P, Sanna M, Zini C. Regenerated middle ear mucosa after tympanoplasty. Part II. Scanning electron microscopy. Otolaryngol Head Neck Surg. 1986 Apr;94(4):430-4. doi: 10.1177/019459988609400404.
PubMed 3086802Ng M, Linthicum FH Jr. Long-term effects of Silastic sheeting in the middle ear. Laryngoscope. 1992 Oct;102(10):1097-102. doi: 10.1288/00005537-199210000-00002.
PubMed 1328786Soper, D.S. (2014). A-priori Sample Size Calculator for Student t-Tests [Software]. Available from http://www.danielsoper.com/statcalc
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Silastic Stenting on Post-Operative Intra-Nasal Re-Mucosalization
- ClinicalTrials.gov ID
- NCT03282058
- Acronym / sponsor ID
- H14-02101
- Conditions
- Pituitary Tumour
- Keywords
- Silastic Stenting, Trans-nasal Endoscopic Surgery, Post-operative Intra-nasal Re-mucosalization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 4 Apr 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic skull base surgery is a relatively new procedure that is now a standard of care for surgeries at the base of the skull; however there are no studies that examine the healing process of the nasal lining with the use of silastic (silicone) stents (or splints) that might be placed at the time of surgery. While there is some evidence to suggest that the use of stents improves wound healing, the decision to use a stent or not is currently up to the preference of the surgeon. To investigate the impact of stents on post-surgical healing, the investigators at Vancouver General Hospital will compare patients undergoing trans-sphenoidal pituitary surgeries with septal flap reconstruction with the use of silastic stents to line the septal donor site, and compare their recovery to those who did not receive stents. The investigators hypothesize that the use of silastic stents in endonasal surgery increases the rate of mucosal healing, and better quality mucosal regeneration, and with no effect on the patients experience after surgery. In this randomized control trial the investigators aim to recruit 26 (13 in each arm) study participants. The primary outcome is to determine the effect of silastic stunting on healing of the naso-septal flap donor site. This objective will be achieved by assessment of endoscopic photographs of healing tissue and histologic assessment of healing tissues. The secondary outcome involves questionnaires that measure the patient's subjective nasal symptoms prior to and following endoscopic skull based surgery. Total time commitment for the study participant is about 4 months across 4 study visits (all of which are part of standard of care): the assessment visit, surgery, 4 weeks post-operative follow up visit and 12 week post-operative follow up visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in one of two groups (stent vs no stent).
| Arm | Type | Receives |
|---|---|---|
| Silastic Stent | Experimental | Device: Silastic StentAt the time of surgery, if the patient is identified in the "silastic stent" arm, dressing of the septal donor site with silastic stents will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely. |
| No Stent | No intervention | –At the time of surgery, if the patient is identified in the "no silastic stent" arm, dressing of the septal donor site without the stent will be performed after reconstruction has been achieved and the surgeon feels that the surgery proceeded routinely - this is currently the standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing trans-sphenoidal endoscopic pituitary surgery at their first post-operative appointment
Key exclusion criteria (3 listed)
- patients with inflammatory sinus conditions
- patients having undergone extensive skull base reconstructions
- patients having received previous radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silastic StentThe silastic stent is a splint made of silicone. | Device | Silastic Stent |
Primary outcome
Determining the effect of silastic stunting on gross level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
Time frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Visual assessment of endoscopic photographs of healing tissue.
Determining the effect of silastic stunting on microscopic level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing.
Time frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Histologic assessment of healing tissues.
Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective nasal symptoms following endoscopic skull based surgery.
Time frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)
Participants will fill out a quality of life questionnaire called Sino-Nasal Outcome Test (SNOT-22).
Determining the effect of silastic stunting on nasa-septal flap donor sites on the patient's subjective post-operative outcomes following endoscopic skull based surgery.
Time frame: Total time approx. 4 months (post-operative follow up at 4 and 12 weeks)
Participants will fill out a post-operative rating scale.
Physician's evaluation of the effect of silastic stunting on nasa-septal flap donor sites following endoscopic skull based surgery.
Time frame: Total time approx. 4 months (surgery; post-operative follow up at 4 and 12 weeks)
Physician will fill out an outcome measures evaluation scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 19909864Bednarski KA, Kuhn FA. Stents and drug-eluting stents. Otolaryngol Clin North Am. 2009 Oct;42(5):857-66, x. doi: 10.1016/j.otc.2009.07.001.
- BackgroundCowin A, McIntosh D, Wormald PJ. Healing of wounds created in the nasal mucosa following endoscopic sinus surgery can be affected by different nasal packing materials. Primary Intention Vol. 10 No. 3 August 2002.
- Background: PubMed 3086802Gamoletti R, Lanzarini P, Sanna M, Zini C. Regenerated middle ear mucosa after tympanoplasty. Part II. Scanning electron microscopy. Otolaryngol Head Neck Surg. 1986 Apr;94(4):430-4. doi: 10.1177/019459988609400404.
- Background: PubMed 1328786Ng M, Linthicum FH Jr. Long-term effects of Silastic sheeting in the middle ear. Laryngoscope. 1992 Oct;102(10):1097-102. doi: 10.1288/00005537-199210000-00002.
- BackgroundSoper, D.S. (2014). A-priori Sample Size Calculator for Student t-Tests [Software]. Available from http://www.danielsoper.com/statcalc
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Janjua, MD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Silastic Stent in people with Pituitary Tumour, run by University of British Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the effect of silastic stunting on gross level healing of the naso-septal flap donor sites in two aspects gross level healing and microscopic level of healing. (time frame: Total time approx. 4 months (pre-operative assessment; surgery; 4 and 12 weeks post-operative follow up appointments)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03282058, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017; AzTrials last refreshed its copy on 29 Oct 2026.