Chronic SinusitisESSNCT03903432
The Feasibility of Using MRI During ESS
A study testing MRI in people with Chronic Sinusitis, run by Roee Landsberg at 1 site in Israel.
Trial summary
Before performing endoscopic sinus surgery (ESS-Endoscopic Sinus Surgery), every candidate for surgery is referred to perform a sinus CT scan of the sinuses. Because of the complicated anatomy of the sinuses and their proximity to vital organs such as the brain, eye, and carotid artery, the surgeon use the CT imaging… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- 15 May 2019to 15 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic sinusitis.
- Patients designated for ESS surgery.
Who cannot join
- Patients who have already undergone ESS and/ or nasal septum/ turbinates surgery.
- Patients with sinus cancer.
- Patients after sinus injury.
- Patients under 18 years of age.
- Extreme Situations: The radiologist who analyzes the CT and MRI will warn of situations in which he or she will detect an increased risk of injury to vital organs.
- These situations will include:
Show all 12Show fewer
- Dehiscence, as seen in CT, in the bony walls of:
- The carotid artery.
- Skull base.
- Medial wall of the orbit.
- Situations in which an anatomical anomaly or distortion of the nasal or sinus cavity is observed in the CT imaging.
- Situations in which the radiologist identifies poor technical quality of the MRI, and, in particular, a poor demonstration of the bony components.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv
Tel Aviv, 972
Assuta Hospital, +972-3-7645464
About this study
Official title: The Feasibility of Using MRI During Endoscopic Sinus Surgery
Before performing endoscopic sinus surgery (ESS-Endoscopic Sinus Surgery), every candidate for surgery is referred to perform a sinus CT scan of the sinuses. Because of the complicated anatomy of the sinuses and their proximity to vital organs such as the brain, eye, and carotid artery, the surgeon use the CT imaging during surgery to adjust the anatomy and to avoid complications such as blindness, brain damage and massive bleeding (0.3%). Sometimes the CT is integrated into a navigation system, although there is no evidence that the use of navigation systems reduces the rate of complications.
The aim of our study is to examine whether ESS can be performed in chronic sinusitis patients using MRI, with CT being used as a backup only.
Read the detailed description
The sinuses are different from person to person and from side to side, and therefore it is essential to be completely familiar with the anatomy of the specific patient.
The sinuses are a maze of cells filled with air and surrounded by thin bony partitions separating the cells, as well as separating the nasal and sinus cavities from the vital organs mentioned.
CT imaging is the standard test because it allows accurate detection of the bony partitions, thus contributing to the accuracy and safety of the operation.
The known disadvantage of the CT is its radiation. The amount of radiation is not negligible and involves the possible development of eye damage (cataracts) or tumors.
For a large number of patients, the CT imaging performed before surgery is neither the first nor the last, so that the risk of tumor disease increases significantly, especially for the younger population. Another disadvantage is the limited ability of the imaging to demonstrate soft tissue.
Compared to CT, MRI is better for soft tissue demonstration. Another important advantage is that it is a radiation-free scan. Its disadvantages are a poor demonstration of the bony partitions and being relatively long, expensive, and therefore less available.
Although the CT is more accurate in demonstrating bony structures, cheaper and more accessible, the radiation risk is very disturbing to both the physicians and patients who have become more aware of the problem in recent years.
Among neurosurgeons, whose field of operation is very close to the surgical field of sinus surgeons (for example, in the trans-sphenoidal surgery of the pituitary gland), surgery is often performed only with MRI.
When a potential patient arrives for sinus surgery with an MRI, some sinus surgeons will skip the CT. However, this practice does not yet have an orderly basis, and that is where the investigators are aiming.
In a previous study, the initiators (rhinologist and neuroradiologist) suggested that MRI parameters could be upgraded to allow a better and clearer demonstration of the bony partitions, so that the surgeon could rely on the anatomy derived from this scan. As a result of the desired change, the patients will not be exposed to radiation, and at the same time, a better demonstration of the soft tissues will also be possible.
In this study, 20 patients who performed CT imaging prior to ESS were sent to perform sinus MRI (new protocol- without gadolinium injection). Twenty-three bony anatomical structures were selected that are important for the surgeon's orientation. The rhinologist and neuroradiologist independently evaluated the CT and MRI of each patient and compared it by giving a numerical score for the degree of visibility of each structure.
In both disciplines, in about 55% of cases, the structures observed in MRI were observed similarly in CT. According to the rhinologist, in 84% the CT was similar or better. According to the neuroradiologist, in 86% the MRI was similar or better. Still, even for the rhinologist, in 67% the MRI was similar or better.
Therefore, according to this protocol, it was found that in both disciplines, most of the anatomical structures are well observed on MRI.
adding the obvious superiority of MRI over CT in soft tissue demonstration, the investigators conclude that MRI use in ESS can be considered at least in some cases.
the investigators assume that a neuroradiologist has an advantage in reading MRI, and that an rhinologist has an advantage in reading CT. It should be expected that over time and after a learning curve, MRI readings among rhinologist will improve. This study is about to be published these days.
Encouraged by its results, it is now necessary to examine the feasibility of the conclusions in real setting.
Endpoints:
- Statistics will be carried out for all 15 questionnaires of each surgeon on questions a-g:
- The level of surgery using MRI
- Safety level using MRI
- Use of CT during surgery
- Continuous work with MRI
- Ease of work in different sinus groups
- Complications when working with MRI
- Would the surgeon's exposure to CT imaging change the operation?
- Statistics will be carried out for all 15 questionnaires of each surgeon on questions a-b.
- Would the surgeons prefer to work with MRI instead of CT?
- Scoring of the following diseases according to the convenience of working with the MRI scan: 1-comfortable, 2-medium, 3-uncomfortable.
- Chronic sinusitis with polyposis (1-2-3)
- Chronic sinusitis without polyposis (1-2-3)
- Antrochoanal polyp (1-2-3)
- Fungal ball (1-2-3)
- Allergic fungal sinusitis (1-2-3)
- Sinus mucocele (1-2-3)
- Odontogenic sinusitis (1-2-3)
- Deviated nasal septum (1-2-3)
- Inferior turbinates hypertrophy (1-2-3)
- Comparative statistics of all the above will be carried out between the average of the questions of the three surgeons.
Number of participants, and number of centers planned to participate in the study:
45 participants, in one center - Assuta
Methods/ protocol:
- Three sinus surgeons will be selected.
- Each surgeon will recruit 15 patients for the study, a total of 45 patients.
- Follow-up patients who are potential candidates for ESS will be referred to conventional CT scans of the sinuses.
- The surgeons will be exposed to the verbal interpretation of the scan, in order to finally decide whether to operate or not, but not to the imaging itself.
- If surgery is to be performed, the patients will sign an informed consent and be referred for a sinus MRI.
- Before surgery, the surgeon will not look at the CT imaging, but only on MRI.
- Prior to surgery, the surgeons will be instructed about the new MRI protocol by the neuroradiologist.
- The operation will be performed when only the MRI is displayed on the screen. However, the CT scan will also be in the operating room in case the surgeon feels that the MRI is insufficient.
- The surgeons will observe the CT scan after the surgery, and then complete the questionnaire.
- Conditions
- Chronic Sinusitis
- Being tested
- MRI
- Keywords
- MRI, CT, Chronic Sinusitis, ESS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Also called CT
candidates for ESS will be referred to conventional CT scans of the sinuses. If surgery is to be performed, the patients will sign an informed consent and be referred for a sinus MRI.
| Study group | Role | What they receive |
|---|---|---|
| 45 participants, in one center - Assuta | Other | Patients with chronic sinusitis who are scheduled to undergo ESS at Assuta will be recruited and patients will sign an informed consent form for performing MRI (new protocol-without gadolinium injection) in addition to the routine CT. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease and saftey of use of MRI compared to CT during ESS
A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery.
- What was your general feeling about this surgery using MRI as compared to a similar surgery in which you used CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE
- Safety level using MRI compared to CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE
- please rate the level of Ease of work in the different sinus groups (on a scale of 1-2-3 where 1- easy 2- somewhat easy 3- not easy)
Measured: imediatly after surgery is done (+- 12 hours)
the impact of using MRI compared to CT during ESS Ease and saftey of use of MRI compared to CT during ESS
A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery.
- How many times was there a sporadic Use of CT during surgery (1-3 times)? (yes / no)
- Was there a need for Continuous work with CT? (yes / no)
- were there any complications when working with MRI ( no / yes, if yes please elaborate)
- Do you think that an exposure to CT imaging would have changed the operation? If yes please elaborate
Measured: imediatly after surgery is done (+- 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start15 May 2019 (estimated)
- Primary completion15 Feb 2020 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roee Landsberg
- Sponsor type
- University, hospital or other
- Collaborators
- Assuta Medical Center
- Responsible party
- Sponsor-investigator, Roee Landsberg, Assuta Medical Center
- Investigators
- Roee Landsberg, M.D, Principal investigator, Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903432
- Sponsor's protocol ID
- 0059-18-ASMC
- Acronym
- ESS
- Status last verified
- Apr 2019
- First submitted
- 30 Jan 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Using MRI During Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT03903432
- Acronym / sponsor ID
- ESS / 0059-18-ASMC
- Conditions
- Chronic Sinusitis
- Keywords
- MRI, CT, Chronic Sinusitis, ESS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Roee LandsbergUniversity, hospital or other
- Collaborators
- Assuta Medical Center
- Study start
- 15 May 2019 (estimated)
- Primary completion
- 15 Feb 2020 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 4 Apr 2019 (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.
Before performing endoscopic sinus surgery (ESS-Endoscopic Sinus Surgery), every candidate for surgery is referred to perform a sinus CT scan of the sinuses. Because of the complicated anatomy of the sinuses and their proximity to vital organs such as the brain, eye, and carotid artery, the surgeon use the CT imaging during surgery to adjust the anatomy and to avoid complications such as blindness, brain damage and massive bleeding (0.3%). Sometimes the CT is integrated into a navigation system, although there is no evidence that the use of navigation systems reduces the rate of complications.
The aim of our study is to examine whether ESS can be performed in chronic sinusitis patients using MRI, with CT being used as a backup only.
Detailed description
The sinuses are different from person to person and from side to side, and therefore it is essential to be completely familiar with the anatomy of the specific patient.
The sinuses are a maze of cells filled with air and surrounded by thin bony partitions separating the cells, as well as separating the nasal and sinus cavities from the vital organs mentioned.
CT imaging is the standard test because it allows accurate detection of the bony partitions, thus contributing to the accuracy and safety of the operation.
The known disadvantage of the CT is its radiation. The amount of radiation is not negligible and involves the possible development of eye damage (cataracts) or tumors.
For a large number of patients, the CT imaging performed before surgery is neither the first nor the last, so that the risk of tumor disease increases significantly, especially for the younger population. Another disadvantage is the limited ability of the imaging to demonstrate soft tissue.
Compared to CT, MRI is better for soft tissue demonstration. Another important advantage is that it is a radiation-free scan. Its disadvantages are a poor demonstration of the bony partitions and being relatively long, expensive, and therefore less available.
Although the CT is more accurate in demonstrating bony structures, cheaper and more accessible, the radiation risk is very disturbing to both the physicians and patients who have become more aware of the problem in recent years.
Among neurosurgeons, whose field of operation is very close to the surgical field of sinus surgeons (for example, in the trans-sphenoidal surgery of the pituitary gland), surgery is often performed only with MRI.
When a potential patient arrives for sinus surgery with an MRI, some sinus surgeons will skip the CT. However, this practice does not yet have an orderly basis, and that is where the investigators are aiming.
In a previous study, the initiators (rhinologist and neuroradiologist) suggested that MRI parameters could be upgraded to allow a better and clearer demonstration of the bony partitions, so that the surgeon could rely on the anatomy derived from this scan. As a result of the desired change, the patients will not be exposed to radiation, and at the same time, a better demonstration of the soft tissues will also be possible.
In this study, 20 patients who performed CT imaging prior to ESS were sent to perform sinus MRI (new protocol- without gadolinium injection). Twenty-three bony anatomical structures were selected that are important for the surgeon's orientation. The rhinologist and neuroradiologist independently evaluated the CT and MRI of each patient and compared it by giving a numerical score for the degree of visibility of each structure.
In both disciplines, in about 55% of cases, the structures observed in MRI were observed similarly in CT. According to the rhinologist, in 84% the CT was similar or better. According to the neuroradiologist, in 86% the MRI was similar or better. Still, even for the rhinologist, in 67% the MRI was similar or better.
Therefore, according to this protocol, it was found that in both disciplines, most of the anatomical structures are well observed on MRI.
adding the obvious superiority of MRI over CT in soft tissue demonstration, the investigators conclude that MRI use in ESS can be considered at least in some cases.
the investigators assume that a neuroradiologist has an advantage in reading MRI, and that an rhinologist has an advantage in reading CT. It should be expected that over time and after a learning curve, MRI readings among rhinologist will improve. This study is about to be published these days.
Encouraged by its results, it is now necessary to examine the feasibility of the conclusions in real setting.
Endpoints:
- Statistics will be carried out for all 15 questionnaires of each surgeon on questions a-g:
- The level of surgery using MRI
- Safety level using MRI
- Use of CT during surgery
- Continuous work with MRI
- Ease of work in different sinus groups
- Complications when working with MRI
- Would the surgeon's exposure to CT imaging change the operation?
- Statistics will be carried out for all 15 questionnaires of each surgeon on questions a-b.
- Would the surgeons prefer to work with MRI instead of CT?
- Scoring of the following diseases according to the convenience of working with the MRI scan: 1-comfortable, 2-medium, 3-uncomfortable.
- Chronic sinusitis with polyposis (1-2-3)
- Chronic sinusitis without polyposis (1-2-3)
- Antrochoanal polyp (1-2-3)
- Fungal ball (1-2-3)
- Allergic fungal sinusitis (1-2-3)
- Sinus mucocele (1-2-3)
- Odontogenic sinusitis (1-2-3)
- Deviated nasal septum (1-2-3)
- Inferior turbinates hypertrophy (1-2-3)
- Comparative statistics of all the above will be carried out between the average of the questions of the three surgeons.
Number of participants, and number of centers planned to participate in the study:
45 participants, in one center - Assuta
Methods/ protocol:
- Three sinus surgeons will be selected.
- Each surgeon will recruit 15 patients for the study, a total of 45 patients.
- Follow-up patients who are potential candidates for ESS will be referred to conventional CT scans of the sinuses.
- The surgeons will be exposed to the verbal interpretation of the scan, in order to finally decide whether to operate or not, but not to the imaging itself.
- If surgery is to be performed, the patients will sign an informed consent and be referred for a sinus MRI.
- Before surgery, the surgeon will not look at the CT imaging, but only on MRI.
- Prior to surgery, the surgeons will be instructed about the new MRI protocol by the neuroradiologist.
- The operation will be performed when only the MRI is displayed on the screen. However, the CT scan will also be in the operating room in case the surgeon feels that the MRI is insufficient.
- The surgeons will observe the CT scan after the surgery, and then complete the questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 45 participants, in one center - Assuta | Other | Other: MRIPatients with chronic sinusitis who are scheduled to undergo ESS at Assuta will be recruited and patients will sign an informed consent form for performing MRI (new protocol-without gadolinium injection) in addition to the routine CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic sinusitis.
- Patients designated for ESS surgery.
Key exclusion criteria (12 listed)
- Patients who have already undergone ESS and/ or nasal septum/ turbinates surgery.
- Patients with sinus cancer.
- Patients after sinus injury.
- Patients under 18 years of age.
- Extreme Situations: The radiologist who analyzes the CT and MRI will warn of situations in which he or she will detect an increased risk of injury to vital organs.
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 |
|---|---|---|
| MRIAlso: CTcandidates for ESS will be referred to conventional CT scans of the sinuses. If surgery is to be performed, the patients will sign an informed consent and be referred for a sinus MRI. | Other | 45 participants, in one center - Assuta |
Primary outcome
Ease and saftey of use of MRI compared to CT during ESS
Time frame: imediatly after surgery is done (+- 12 hours)
A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery. 1. What was your general feeling about this surgery using MRI as compared to a similar surgery in which you used CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE 2. Safety level using MRI compared to CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE 3. please rate the level of Ease of work in the different sinus groups (on a scale of 1-2-3 where 1- easy 2- somewhat easy 3- not easy)
the impact of using MRI compared to CT during ESS Ease and saftey of use of MRI compared to CT during ESS
Time frame: imediatly after surgery is done (+- 12 hours)
A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery. 1. How many times was there a sporadic Use of CT during surgery (1-3 times)? (yes / no) 2. Was there a need for Continuous work with CT? (yes / no) 3. were there any complications when working with MRI ( no / yes, if yes please elaborate) 4. Do you think that an exposure to CT imaging would have changed the operation? If yes please elaborate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
Roee Landsberg, M.D principal investigator
Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Chronic Sinusitis, run by Roee Landsberg at 1 site in Israel.
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 2 inclusion and 12 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Roee Landsberg, M.D (+972524266359, roeela@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease and saftey of use of MRI compared to CT during ESS (time frame: imediatly after surgery is done (+- 12 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2019.