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Auris Nasus Larynx

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Treatment outcomes of sialendoscopy for submandibular gland

sialolithiasis: The minor axis of the sialolith is a regulative factor
for the removal of sialoliths in the hilum of the submandibular
gland using sialendoscopy alone
Norio Kondo a,*, Toshio Yoshihara b,1, Yukie Yamamura a, Kaoru Kusama a,
Eri Sakitani a, Yukako Seo a, Mayako Tachikawa a, Keiko Kujirai a, Erika Ono a,
Yasuyo Maeda a, Tomohito Nojima a, Akiko Tamiya a, Emiri Sato a, Manabu Nonaka a
a
Department of Otolaryngology, Tokyo Women’s Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
b
Department of Otolaryngology, Tohto Bunkyo Hospital, 3-5-7, Yushima, Bunkyo-ku, Tokyo 113-0034, Japan

A R T I C L E I N F O A B S T R A C T

Article history: Objective: To assess the general guidelines for the removal of sialoliths for submandibular gland
Received 18 March 2017 sialolithiasis using sialendoscopy alone.
Accepted 5 September 2017 Methods: We analyzed 61 sialoliths treated using sialendoscopy in 42 patients with submandibular
Available online xxx
gland sialolithiasis. We evaluated the submandibular gland sialoliths and divided each case based
upon the location: the Wharton’s duct or the hilum. We measured the major and minor axes of the
Keywords:
sialoliths using a soft tissue computed-tomography (CT) scan and evaluated the removal rate of the
Sialendoscopy
Sialolithiasis
sialoliths using sialendoscopy alone.
Submandibular gland Results: The removal rate of the sialoliths in the Wharton’s duct (52.6%) was significantly higher
Size than that in the hilum of the submandibular gland (26.1%) (P = 0.042). The minor axis was
Minor axis significantly correlated to the treatment outcome of sialendoscopy alone for all cases (P = 0.030). A
Hilum significant correlation was observed for cases involving the hilum of the submandibular gland and
the measurement of the minor axes of the sialoliths for the treatment outcome of sialendoscopy alone
(P = 0.009). The major axis showed no correlation with the treatment outcomes of sialendoscopy
alone.
Conclusion: The measurement of the minor axes of the sialoliths with a soft tissue CT scan was
correlated with treatment outcome of sialendoscopy alone for all cases, particularly sialoliths in the
hilum. The easurement of the major axis showed no correlation with outcomes of sialendoscopy
alone.
© 2017 Elsevier B.V.. All rights reserved.

1. Introduction

Obstructive salivary gland disease is mainly caused by the

* Corresponding author at: Department of Otolaryngology, Tokyo Women’s formation of sialoliths. In 80–90% of the cases, there is
Medical University, 8-1, Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan. involvement of the submandibular gland, followed by the
Fax: +81 03 5269 7351.
parotid (5–10%) and sublingual (<1%) glands [1]. The longer
E-mail address: kondo.norio@twmu.ac.jp (N. Kondo).
1
Fax: +81 03 3837 5916. length of the major duct is likely a factor, as well as the nature

http://dx.doi.org/10.1016/j.anl.2017.09.003
0385-8146/© 2017 Elsevier B.V.. All rights reserved.

Please cite this article in press as: Kondo N, et al. Treatment outcomes of sialendoscopy for submandibular gland sialolithiasis: The minor axis
of the sialolith is a regulative factor for the removal of sialoliths in the hilum of the submandibular gland using sialendoscopy alone. Auris Nasus
Larynx (2017), http://dx.doi.org/10.1016/j.anl.2017.09.003
G Model
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2 N. Kondo et al. / Auris Nasus Larynx xxx (2017) xxx–xxx

and consistency of the submandibular gland saliva, which can

have a thick consistency, phosphorous content, and an alkaline
pH conducive to calculi formation [2]. Obstructive sialadenitis
was usually managed conservatively, while surgical treatment
was reserved for refractory cases, ranging from papillotomy to
sialadenectomy [3]. Nonetheless, these procedure carry the risk
of nerve injury, infection, incidence of salivary fistula, and can
result in obvious scarring [4]. Sialendoscopy was first proposed
as a minimally invasive technique by Katz in 1990 [5], allowing
for the direct visualization of the salivary duct and the removal
of sialoliths without skin or mucosa incision. For submandibu-
lar gland sialolithiasis, there were several limiting factors
affecting the removal of sialoliths via sialendoscopy alone,
including the size, location (hilum or the middle and distal parts
of the duct), adhesion of the sialolith, and the presence of a
stenotic duct [6–8]. In these cases, the presentation of sialoliths
within the Wharton’s duct and the hilum were discussed
together as a submandibular gland sialolith. Conversely, we
proposed that there are differences in the removal rate and the
regulation protocols for sialendoscopic surgery for sialoliths
Fig. 1. The measurement of the size of the sialoliths and the distance between
occurring within the Wharton’s duct and the hilum. For the sublingual caruncle (papilla) and the anterior edge the sialolith using a soft
submandibular gland sialolithiasis, we separately analyzed the tissue computed-tomography (CT) scan. (A) The major axis of the sialolith; (B)
removal rates and regulation factors of sialendoscopic surgery the minor axis of the sialolith; (C) the distance between the sublingual caruncle
for sialoliths occurring within the Wharton’s duct and the (papilla) and the anterior edge the sialolith.
hilum.
sublingual caruncle (papilla) and the anterior edge the sialolith
2. Material and methods using a soft tissue CT scan.

2.1. Patients 2.3. Surgical procedure

Between August 2009 and May 2016, 42 patients with
submandibular gland sialolithiasis underwent sialendoscopic
surgery, which was performed at the Department of Otolaryn-
gology at the Tokyo Women’s Medical University, Tokyo,
Japan. Several cases involved multiple stones in the Wharton’s
duct and the hilum of the submandibular gland, and a total of
61 attempts were made to remove the sialoliths with
sialenodscopy. We retrospectively reviewed the findings of
these 42 cases (13 men and 29 women, between 15 and 75 years
of age) involving 61 sialoliths. The protocol was approved by
the Ethics Committee of the hospital.
2.2. Localization and size of sialoliths
We analyzed the submandibular gland sialoliths and divided
each case based on the area of involvement: the Wharton’s duct
or the hilum of the submandibular gland. We determined that
the formation of sialoliths within the submandibular gland was
an adverse event from sialendoscopic surgery. We recorded the
locations and size of each sialolith according to the following
classification. We measured the major and minor axes of the
sialoliths using a soft tissue computed tomography (CT) scan
(Fig. 1), which had been acquired from all patients. Many
patients did not have bone condition images. Particularly,
patients referred to our department from other hospitals had CT
scan images previously acquired during treatment, and these
patients often lacked bone condition images. For the sialoliths
in the Wharton’s duct, we measured the distance between the
Forty-one patients were placed under general anesthesia for
the procedures, and one case was treated using local anesthesia.
For each patient, after adequate dilation of the papilla, a semi-
rigid endoscope, 1.3 mm in diameter, (Karl Storz, Tuttlingen,
Germany) was inserted into the Wharton’s duct. Saline was
administered through the scope’s irrigation channel, and the
sialendoscope was slowly passed into the Wharton’s duct. If the
papilla was not identified, we incised the oral floor mucosa,
identified the Wharton’s duct, and incised it. In these cases, the
sialendoscope was inserted into the incised area. If the
sublingual gland was obstructive, the sublingual gland would
be resect. When the sialolith was identified, all-in-one miniature
endoscope measuring 1.6 mm in diameter (Karl Storz,
Tuttlingen, Germany) would be used. For the removal of the
sialoliths, we utilized grasping forceps, biopsy forceps, a basket
catheter used for urinary calculus extraction (stone extractor),
and a balloon catheter used for the treatment of coronary
arteries. If we were unable to completely remove a sialolith with
sialendoscopy alone, we alternated to an intraoral approach or
open surgery. If the patients refused an approach involving skin
incision, the sialolith was left in place. We always confirm
patient’s hope before surgery if we are not able to remove stones
with sialendoscopy.
We did not use extracorporeal shockwave lithotripsy
(ESWL) or thulium-YAG laser for the fragmentation of the
sialoliths. In each case, we recorded the method of removal or
indicated the reasons for which the sialolith was not removed
with sialendoscopy alone.

Please cite this article in press as: Kondo N, et al. Treatment outcomes of sialendoscopy for submandibular gland sialolithiasis: The minor axis
of the sialolith is a regulative factor for the removal of sialoliths in the hilum of the submandibular gland using sialendoscopy alone. Auris Nasus
Larynx (2017), http://dx.doi.org/10.1016/j.anl.2017.09.003
G Model
ANL-2353; No. of Pages 5
N. Kondo et al. / Auris Nasus Larynx xxx (2017) xxx–xxx
Table 1
The removal rates of submandibular gland sialoliths treated with sialendoscopy alone at each location (n = 61).
Removed Not removed
Hilum of the submandibular gland 6 17
Wharton’s duct 20 18
Total 26 35
*
Chi-square for independence test. Statistical significance was defined as p < 0.05.
2.4. Statistical analysis
We used the Student’s t-test to compare the sizes of the
sialoliths and the Chi-square test as an independent test for a
comparison of the removal rates based on the location of the
sialoliths. Statistical significance was defined as p < 0.05.
3. Results
Table 1 shows the location of the sialoliths in the
submandibular gland and the removal rates of the sialoliths
using sialendoscopy alone. The total removal rate of the
sialoliths was 42.6%. The removal rate of sialoliths in the
Wharton’s duct (52.6%) was significantly higher than that in the
hilum of the submandibular gland (26.1%) (P = 0.042). Table 2
shows the mean size of the submandibular gland sialoliths from
each location. The minor axis of the sialoliths was shown to be
significantly correlated with its removal using sialendoscopy
alone (P = 0.030). The presence of sialoliths within the hilum of
the submandibular gland also showed significant correlation to
the minor axes of the sialoliths (P = 0.009). Nonetheless, this
correlation was not evident for cases of involving the Wharton’s
duct. The major axis showed no correlation to the treatment
outcome of sialendoscopy for each location. Table 3 shows the
removal rates of the sialoliths from the hilum of the
submandibular gland using sialendoscopy alone based upon
each minor axis. Sialoliths 33 mm had a high removal rate
(80.0%: 4/5), but those <3 mm had a very low rate. The
removal rate reduced proportionally to the minor axis of
sialolith. Table 4 shows the mean distance from the sublingual
caruncle to the anterior edge of the sialolith in the Wharton’s
duct. The distance of the sublingual caruncle to the anterior
edge of sialolith showed no correlation with treatment outcomes
of sialendoscopy for each location (P = 0.69).
Table 5 shows the reasons for inability to remove sialoliths
with sialendoscopy alone at each location. The most prevalent
reason was stenosis of the Wharton’s duct and the area proximal
to the Wharton’s duct near to the sialolith. Nonetheless, the
incidence of an adherent or impacted sialolith was the main
Table 2
The mean size of the submandibular gland sialoliths for each location (n = 61).
Removed
Major axis (mm) Minor axis (mm)
Hilum of the submandibular gland 5.4 (3.3–11.5) 3.2 (1.8–5.5)
Wharton’s duct 5.5 (3.1–9.5) 3.9 (2.1–6.2)
Total 5.5 (3.3–11.5) 3.7(1.8–6.2)
*
Student’s t-test. Statistical significance was defined as p < 0.05.
Please cite this article in press as: Kondo N, et al. Treatment outcomes of sialendoscopy for submandibular gland sialolithiasis: The minor axis
of the sialolith is a regulative factor for the removal of sialoliths in the hilum of the submandibular gland using sialendoscopy alone. Auris Nasus
Larynx (2017), http://dx.doi.org/10.1016/j.anl.2017.09.003
3
Removal rate (%) P value (Hilum vs. Wharton’s duct)
26.1 0.042 (significant)*
52.6
42.6
reason for inability to remove sialoliths using sialendoscopy
alone in the hilum of the submandibular gland.
Average operation time was 88.6 min and average hospitali-
zation was 7.2 days in the surgery of sialendoscopy alone.
There was no recurrence in cases of complete removal of
sialoliths. Follow up period was about 6 months when complete
removal was achieved.
4. Discussion
Sialendoscopy was first introduced by Katz [9] in 1991 and
has since been developed by Marchael et al. [10] and Nahlieli
et al. [11]. The innovation of sialendoscopy allows for the direct
visualization of the salivary ductal system and is a minimally
invasive surgical technique for organ preservation. Sialolithia-
sis is the main cause of obstructive sialadenitis. The
submandibular gland is most frequently affected by sialolithia-
sis (87%), followed by the parotid (10%), and sublingual (3%)
glands [12]. As such, there are many reports on sialendoscopic
surgery for submandibular gland sialolithiasis. In these reports,
various clinical factors were described for the removal of
sialoliths in the submandibular gland using sialendoscopy
alone. Klein and Ardekian [13] indicated that sialoliths of up to
4–5 mm were suitable for sialendoscopy, and that sialoliths
located deep within hilum would be challenging for surgeons.
Dabirmoghaddam and Hosseinzadehnik [7] indicated that there
was a lack of consensus on the maximum diameter of the stones
that could be removed without fragmentation, and that impacted
or hard stones cannot be managed effectively by an endoscopic
approach alone. In other reports, the maximum sialolith size for
removal using sialendoscopy varied between 3 and 7 mm
[2,14–16]. Therefore, the criteria for the removal of subman-
dibular gland sialoliths using sialendoscopy alone is unclear.
We thought that investigation into the clinical factors
surrounding the removal rate of submandibular gland sialoliths
using sialendoscopy would be informative for patients.
Therefore, we investigated the location, and the size of the
sialoliths using a soft tissue CT scan. We hypothesized that
there was a clinical difference between the treatment outcomes
Not removed P value (removed vs. not removed)
Major axis (mm) Minor axis (mm) Major axis Minor axis
6.6 (3.0–13.3) 5.2 (3.6–8.2) 0.30 0.009 (significant)*
5.8 (3.0–12.3) 4.1 (1.9–9.6) 0.69 0.77
6.2 (3.0–13.3) 4.6 (1.9–9.6) 0.25 0.030 (significant)*
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Table 3
The removal rate of the sialoliths located in the hilum of the
submandibular gland using sialendoscopy alone following measure-
ment of the minor axis (n = 24).
Minor axis Removal rate (%)
3 <
3 mm 80.0 (4/5) 15.8 (3/19)
4 mm 54.5 (6/11) 7.7 (1/13)
5 mm 42.9 (6/14) 10.0 (1/10)
6 mm 36.8 (7/19) 0 (0/5)
for the removal of sialoliths within the Wharton’s duct and the
hilum. Therefore, we individually evaluated the clinical factors
of each case and divided them into the following: the Wharton’s
duct or the hilum.
The removal rates of sialoliths using sialendoscopy alone for
the Wharton’s duct are considerably higher than that of the
hilum (P = 0.042) (Table 1). The location of the sialolith (in the
Wharton’s duct or the hilum) is an important clinical factor.
Subsequently, we evaluated the major and minor axes of the
sialoliths for the Wharton’s duct and the hilum. There was no
significant improvement in the removal rate of sialoliths, or in
the treatment outcome of sialendoscopy, following the
evaluation of the major axes of the sialoliths, but a significant
correlation was indicated for the minor axes (P = 0.030), or for
the location of the hilum (P = 0.009) (Table 2). These results
suggested that the measurement of the minor axis is important
for the evaluation of the size of the submandibular gland
sialoliths, particularly in the hilum, prior to sialendoscopic
surgery. When evaluating the relationship between the
endoscopic removal of the sialoliths and the size of the
sialoliths, the size of the removed sample is usually used for the
evaluation. From our results, the minor axes of the sialoliths,
particularly following soft tissue CT scan evaluation, may
provide important information prior to sialendoscopic surgery.
We evaluated the removal rates of sialoliths using
sialendoscopy alone, in addition to measuring the minor axes
of the sialoliths within the hilum (Table 3). When the minor axis
of the sialolith is 23 mm, the removal rate was 80.0%.
Sialoliths within the hilum that were larger than 3 mm had a
removal rate of only 15.8%. The removal rates of sialoliths
within the hilum were inversely reduced as the minor axis of the
sialolith increased. The evaluation of the minor axis of sialoliths
smaller than 3 mm may be importance for the success of the
treatment for hilar sialoliths. This information may be helpful
for surgeons using sialendoscopy, and for patients with
sialolithiasis in the hilum of the submandibular gland.
Table 4
The mean distance from the sublingual caruncle to the anterior edge of the sialolith in the Wharton’s duct (n = 38).
Mean distance (mm)
Removed (n = 20) 17.7 (2.6–40.3)
Not removed (n = 18) 19.8 (0–44.3)
Total (n = 38) 18.7 (0–44.3)
*
Student’s t-test. Statistical significance was defined as p < 0.05.
Please cite this article in press as: Kondo N, et al. Treatment outcomes of sialendoscopy for submandibular gland sialolithiasis: The minor axis
of the sialolith is a regulative factor for the removal of sialoliths in the hilum of the submandibular gland using sialendoscopy alone. Auris Nasus
Larynx (2017), http://dx.doi.org/10.1016/j.anl.2017.09.003
The size of the sialolith showed no correlation to the
treatment outcome for the removal of the sialolith within the
Wharton’s duct. Next, we measured the distance between the
sublingual caruncle (papilla) to the anterior edge of the
sialoliths, and determined that there was no correlation between
this anatomical parameter and the removal rate (P = 0.690)
(Table 4).
We were unable to determine the clinical factors affecting
the treatment success of sialolith removal for the Wharton’s
duct following endoscopic surgery. Therefore, we investigated
the limitations of sialendoscopy. Stenosis of the duct was
considered the main reason for inability to remove sialoliths
using sialendoscopy alone within the Wharton’s duct.
Conversely, the incidence of adhesion or impaction of the
sialoliths is main reason for hilar sialoliths (Table 5). It is
difficult to predict the incidence of stenotic ducts or adherent or
impacted sialoliths within a patient with submandibular gland
sialolithiasis. Although sialography may be a useful imaging
modality for the evaluation of stenotic ducts, it may be difficult
to evaluate whether sialendoscope insertion is accomplished or
not. Narrower sialendoscopy may result in higher removal rates
for the incidence of sialoliths within the Wharton’s duct. As the
incidence of adherent or impacted sialoliths was a significant
obstacle in the removal of hilar sialoliths with sialendoscopy,
the mean values of minor axes for adherent or impacted hilar
sialolith were evaluated. The mean values of the minor axes of
adherent or impacted hilar sialoliths were 5.4 mm. And the
mean values of the minor axes of the sialoliths that were not
removed because of stenosis of the duct were 5.1 mm. These
values were similar to those measured from the sialoliths that
were not removed from the hilum (5.2 mm) (Table 2) and
statistical significance was not observed between each minor
axes (P = 0.706). The minor axis of sialolith is not necessarily
correlated with adhesion or impaction of the sialoliths in the
hilum. Generally, minor axis of sialoliths exist as a right angle
to the Wharton’s duct in the hilum of the submandibular gland.
Therefore, minor axis may correlate to the pressure between
stone and intraductal wall. Although statistical significance was
not observed, minor axis may influence adhesion of stone and
intraductal wall. Sex and age of the patients were not correlated
with adhesion or impaction of the sialoliths too. Preoperative
abscess was observed in two cases of sialoliths in the hilum and
these cases showed adhesion of sialoliths. However, we are not
able to define the preoperative abscess as predictive factor of
adhesion or impaction, because the number of cases were
limited. Therefore, it is difficult to predict the incidence of
adherent or impacted sialoliths in the hilum before surgery.
Several methods for the intra- and extracorporeal fragmen-
tation of sialoliths were used for patients with large or impacted
P value (removed vs. not removed)
0.69
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N. Kondo et al. / Auris Nasus Larynx xxx (2017) xxx–xxx
Table 5
Reasons for inability to remove sialolith using sialendoscopy alone (n = 35).
Hilum of the submandibular gland (n = 17)
Stenosis of the duct 5 13
Adhesion or impaction 11
Not found 1 1
sialoliths. ESWL [6] and thulium-YAG laser [17] are the typical
procedures for the fragmentation of sialoliths. These procedures
are expensive, so only a few hospitals are able to afford these
treatment methods. Additionally, these treatment methods have
not yet to be approved in Japan, and our hospital does not
perform them, despite their improvement of treatment efficacy
for the removal of hilar sialoliths. Our removal rate might be
lower than other studies [2]. Introduction of procedures for the
fragmentation of sialoliths may contribute to higher removal
rate. Conversely, the incidence of a stenotic duct may be a main
reason for inability to remove sialoliths within the Wharton’s
duct, and may be a barrier to attaining better treatment outcomes
with sialendoscopy for cases involving the Wharton’s duct. As
the insertion of the sialendoscope was required for the removal
of sialolith fragments, the incidence of a stenotic duct may be
also an obstacle for the rmoval of sialoliths within the
Wharton’s duct when fragmentation device is used.
Most of our surgery were performed under general
anesthesia and one case was performed under local anesthesia.
We might be able to adapt more cases for under local
anesthesia. We thought the cases of small stone in the
Wharton’s duct with large orifice of papilla is suitable for under
local anesthesia.
5. Conclusion
This study evaluated the removal rates of sialoliths in the
submandibular gland using sialendoscopy alone by comparing
the location and size of the sialoliths. The minor axis of the
sialoliths with a soft tissue CT scan was correlated to the
treatment outcome of sialendoscopy and the sialoliths located in
the hilum of the submandibular gland. The major axis showed
no correlation to the treatment outcome of sialendoscopy. The
incidence of stenotic duct was a main reason for inability to
remove sialoliths using sialendoscopy alone in the Wharton’s
duct, whereas adherent or impacted sialoliths was a main reason
in the hilum except for the minor axis of sialoliths.
Ethical statement
This study was approved by Institutional Ethics Board of
Tokyo Women’s Medical University (Ref. No: 20.12.2016,
4202).
Please cite this article in press as: Kondo N, et al. Treatment outcomes of sialendoscopy for submandibular gland sialolithiasis: The minor axis
of the sialolith is a regulative factor for the removal of sialoliths in the hilum of the submandibular gland using sialendoscopy alone. Auris Nasus
Larynx (2017), http://dx.doi.org/10.1016/j.anl.2017.09.003
5
Wharton’s duct (n = 18) Total (n = 35)
18
4 15
2
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