Chronic Sinusitis Clinical Trial
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.
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:
1. Statistics will be carried out for all 15 questionnaires of each surgeon on questions
a-g:
1. The level of surgery using MRI
2. Safety level using MRI
3. Use of CT during surgery
4. Continuous work with MRI
5. Ease of work in different sinus groups
6. Complications when working with MRI
7. Would the surgeon's exposure to CT imaging change the operation?
2. Statistics will be carried out for all 15 questionnaires of each surgeon on questions
a-b.
1. Would the surgeons prefer to work with MRI instead of CT?
2. Scoring of the following diseases according to the convenience of working with the
MRI scan: 1-comfortable, 2-medium, 3-uncomfortable.
1. Chronic sinusitis with polyposis (1-2-3)
2. Chronic sinusitis without polyposis (1-2-3)
3. Antrochoanal polyp (1-2-3)
4. Fungal ball (1-2-3)
5. Allergic fungal sinusitis (1-2-3)
6. Sinus mucocele (1-2-3)
7. Odontogenic sinusitis (1-2-3)
8. Deviated nasal septum (1-2-3)
9. Inferior turbinates hypertrophy (1-2-3)
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.
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