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Balloon catheter sialoplasty: a safety and feasibility pilot study
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British Journal of Oral and Maxillofacial Surgery 51 (2013) 228–230
Balloon catheter sialoplasty: a safety and feasibility pilot study S. Sionis a , A. Vedele a , P.A. Brennan c , D. Fanni b , R. Puxeddu a,∗ a b c
Department of Otorhinolaryngology, AOU, P.O. S Giovanni di Dio, University of Cagliari, Via Ospedale 54, 09124 Cagliari, Italy Department of Pathology, AOU, P.O. S Giovanni di Dio, University of Cagliari, Via Ospedale 54, 09124 Cagliari, Italy Department of Oral and Maxillofacial Surgery, Queen Alexandra Hospital, Portsmouth PO6 3LY, UK
Accepted 25 June 2012 Available online 15 July 2012
Abstract Obstructive sialoadenitis is the most common non-neoplastic disorder of the salivary glands. With advances in the use of diagnostic and interventional sialoendoscopy in the major salivary glands, operations can often be less invasive and treatment can spare the gland and restore normal function. By using an expandable balloon catheter to dilate ductal stenosis during sialoendoscopy it is possible to dilate a stenotic duct and remove large stones with or without a basket. However, the use of different angiocatheters or dedicated balloons is still empirical. In this pilot study we assessed the feasibility and safety of balloon dilatation of the submandibular gland (Wharton’s duct). We did balloon catheter sialoplasty on four ducts from two fresh adult cadavers. We used a non-compliant dilating balloon catheter 6 mm in diameter at a pressure of 12 × 105 Pa for a total of three minutes and then examined the ducts histologically. There was no damage to the wall of Wharton’s duct. Although this is a small study, we have shown the safety of balloon catheter sialoplasty for the first time as assessed histologically after dilatation of the duct. By virtue of the technique histological assessment is not possible after dilatation in patients. Long-term follow up is clearly required in this rapidly evolving area of surgery. © 2012 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved. Keywords: Balloon dilatation; Wharton’s duct; Sialoendoscopy
Introduction Obstructive sialoadenitis results in painful swelling, usually during mealtimes, and sialolithiasis is the most common aetiology. Other causes include strictures, mucus debris, anatomical abnormalities of the duct, and scar tissue. Recent technological advances have led to the development of several conservative options for the treatment of obstructive salivary disorders of the ducts (sialolithiasis and stenosis) such as external lithotripsy,1 interventional radiology,2 and sialoendoscopy.1,3–5 Nowadays, the use of diagnostic and interventional sialoendoscopy in the major ∗
Corresponding author. Tel.: +39 0706092539; fax: +39 070660622. E-mail address: [email protected] (R. Puxeddu).
salivary glands enable more accurate diagnosis and safer and less invasive surgery with the prospect of sparing the gland and restoring normal function. The use of an expandable balloon catheter to dilate the duct during sialoendoscopy enables stenosis to be treated and bigger stones to be removed with or without a basket, but the use of different angiocatheters or dedicated balloons is still empirical. The principle of treatment is analogous to the dilatation of the lumen of arterial vessels in coronary angioplasty. We aimed to assess the feasibility and safety of balloon catheter sialoplasty on Wharton’s duct in fresh cadavers to standardise its clinical application for the treatment of patients with obstructive sialoadenitis. Detailed histological examination of microslices of the duct was done to verify the effect on the ductal wall.
0266-4356/$ – see front matter © 2012 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.bjoms.2012.06.011
S. Sionis et al. / British Journal of Oral and Maxillofacial Surgery 51 (2013) 228–230
229
Fig. 2. Salivary duct characterised by a wide lumen and a single layer of cuboidal epithelial cells before balloon catheter sialoplasty (haematoxylin and eosin, original magnification × 5).
interruption in the full thickness, or laceration of the mucosal epithelium (Figs. 2 and 3).
Discussion Fig. 1. A submandibular gland next to an inflated balloon catheter after dilatation of the duct.
Material and methods Four Wharton’s ducts were dilated with a balloon catheter for sinuplasty (Lenio® cat, Fentex Medical GmbH, Neuhausen ob Eck, Germany) and removed from two different fresh cadavers during dissection of the major salivary glands. A balloon catheter 16 mm long was introduced into the duct and, once correctly placed to reach the proximal position, was inflated with saline solution to its maximum diameter (6 mm) to a pressure of 12 × 105 Pa using a high-pressure syringe. After leaving the balloon fully inflated for one minute, the pressure was released, and after three dilatations the balloon was removed (Fig. 1). The specimens were fixed in 10% formalin solution for at least one week and every duct was sliced into at least 5 sections to evaluate the difference between the parts that had and had not been dilated. Sections were mounted on histological slides and were stained with haematoxylin and eosin to enable us to look for histopathological changes that suggested damage to the ductal wall.
Dilatation of the main duct of a salivary gland can be useful in the treatment of congenital or post inflammatory stenosis, or when removing a stone. The success rate for endoscopic removal of salivary stones falls from 97% to 35% if the stone is more than 3 mm in diameter.6 The possibility that a part, or the whole of the main duct can be safely dilated increases the indications for conservative treatment of any obstruction. It is now necessary to prove scientifically the feasibility and safety of using dilating balloon catheters so that balloon catheter sialoplasty can be introduced routinely as an adjuvant treatment with sialoendoscopy. The maximum diameter of Wharton’s duct is around 2 mm (mean values varied from 1.5 to 0.5 mm, range
Results Histological examination showed no serious acute damage to the wall of the salivary duct, and only minor changes on the epithelium were observed. We found focal disruption of the epithelium of the lumen only in the duct. We did not find any
Fig. 3. Salivary duct lined by a single layer of cuboidal epithelial cells showing focal disruption of the epithelium after balloon catheter sialoplasty (haematoxylin and eosin, original magnification × 5).
230
S. Sionis et al. / British Journal of Oral and Maxillofacial Surgery 51 (2013) 228–230
2.2–0.2),7 but in obstructive disease when proximal dilatation is caused by salivary stasis or the presence of a stone, further stenosis caused by post inflammatory changes can also be present, although congenital stricture or kinking have been associated.8 If the stone is bigger than the normal diameter of the duct it is impossible to retrieve it with grasping forceps or a basket during sialoendoscopy without the use of laser lithotripsy. Using the expandable balloon catheter to dilate the stenosis or strictures, it is sometimes possible to pass through the narrow area and remove the stone without the need for endoluminal fragmentation. The excessive traction of a retained stone in a narrow duct can strip the duct, which is considered a serious complication of the endoscopic approach.5 Balloon dilatation has largely been used for angioplasty, and in the head and neck for sinuplasty,9 conservative treatment of laryngotracheal stenosis,10 conservative treatment of the nasolacrimal duct,11 and stenosis of the eustachian tube.12 Damage to anatomical structures and to the wall is extremely rare and it is considered safe, but although the use of balloon catheter sialoplasty has been reported we know of no anatomical studies about the standardisation of the technique, or its safety and feasibility. The accidental tearing of the ductal wall, for example, could potentially lead to deep neck abscesses after extravasation of the irrigation solution and debris during sialoendoscopy with potentially medicolegal consequences. The lack of any serious injury to the wall when a 6 mm non-compliant balloon was used in our study confirms that the procedure is feasible and safe, and could be used as a conservative approach for obstructive disease of Wharton’s duct without risking a tear in the wall. Histological examination showed that a non-compliant balloon offers steady dilatation with only minor disruption of the epithelium. The possibility of through-and-through damage of the wall during the procedure is also reduced by the fact that the main duct will have thickened as a consequence of chronic inflammation. We showed this in our scanning electron microscope (SEM – ISI SS40) study on normal and pathological major salivary ducts.13 We recognise that the presence of artefacts from the pathological processing post-mortem in the cadaveric material would alter its resistance to applied forces. However, the cadavers were fresh and the changes post-mortem are usually limited initially to the mucosa. We aimed to stress the duct mechanically to find out if there were any lacerations or serious mucosal damage. In live patients these can induce inflammation or infection deep in the neck after leakage of
endoluminal fluids or debris, and subsequently cause stenosis after operation. Clearly, in a cadaveric study, we cannot evaluate the later effect of dilatation – for example, in possibly inducing inflammation, but in the absence of any tear in the duct, this seems unlikely. It is feasible to dilate the ducts of major salivary glands during sialoendoscopy in cases of narrowing or stenosis that is or is not associated with a large stone. Dilatation of the duct may be the crucial step that allows the stone to be drawn out.
References 1. Nahlieli O, Baruchin AM. Long-term experience with endoscopic diagnosis and treatment of salivary gland inflammatory diseases. Laryngoscope 2000;110:988–93. 2. Drage NA, Brown JE, Escudier MP, McGurk M. Interventional radiology in the removal of salivary calculi. Radiology 2000;214: 139–42. 3. Maresh A, Kutler DI, Kacker A. Sialoendoscopy in the diagnosis and management of obstructive sialadenitis. Laryngoscope 2011;121:495–500. 4. Lari N, Chossegros C, Thiery G, Guyot L, Blanc JL, Marchal F. Sialendoscopy of the salivary glands. Revue de Stomatologie et de Chirurgie Maxillo-Faciale 2008;109:167–71 [in French]. 5. Marchal F, Dulguerov P, Becker M, Barki G, Disant F, Lehmann W. Submandibular diagnostic and interventional sialendoscopy: new procedure for ductal disorders. Annals of Otology, Rhinology and Laryngology 2002;111:27–35. 6. Marchal F, Dulguerov P. Sialolithiasis management: the state of the art. Archives of Otolaryngology – Head and Neck Surgery 2003;129: 951–6. 7. Zenk J, Hosemann WG, Iro H. Diameters of the main excretory ducts of adult human submandibular and parotid gland: a histologic study. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontics 1998;85:576–80. 8. Ngu RK, Brown JE, Whaites EJ, Drage NA, Ng SY, Makdissi J. Salivary duct strictures: nature and incidence in benign salivary obstruction. Dentomaxillofacial Radiology 2007;36:63–7. 9. Vaughan WC. Review of balloon sinuplasty. Current Opinion in Otolaryngology & Head and Neck Surgery 2008;16:2–9. 10. Durden F, Sobol SE. Balloon laryngoplasty as a primary treatment for subglottic stenosis. Archives of Otolaryngology – Head and Neck Surgery 2007;133:772–5. 11. Kuchar A, Steinkogler FJ. Antegrade balloon dilatation of nasolacrimal duct obstruction in adults. British Journal of Ophthalmology 2001;85:200–4. 12. Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope 2010;120:1411–6. 13. Testa-Riva F, Congiu T, Lantini MS, Puxeddu R, Riva A. The main excretory duct (Stensen’s) of the human parotid gland: a transmission and scanning electron microscope study. Archives of Histology and Cytology 1995;58:435–48.
British Journal of Oral and Maxillofacial Surgery 51 (2013) 228–230
Balloon catheter sialoplasty: a safety and feasibility pilot study S. Sionis a , A. Vedele a , P.A. Brennan c , D. Fanni b , R. Puxeddu a,∗ a b c
Department of Otorhinolaryngology, AOU, P.O. S Giovanni di Dio, University of Cagliari, Via Ospedale 54, 09124 Cagliari, Italy Department of Pathology, AOU, P.O. S Giovanni di Dio, University of Cagliari, Via Ospedale 54, 09124 Cagliari, Italy Department of Oral and Maxillofacial Surgery, Queen Alexandra Hospital, Portsmouth PO6 3LY, UK
Accepted 25 June 2012 Available online 15 July 2012
Abstract Obstructive sialoadenitis is the most common non-neoplastic disorder of the salivary glands. With advances in the use of diagnostic and interventional sialoendoscopy in the major salivary glands, operations can often be less invasive and treatment can spare the gland and restore normal function. By using an expandable balloon catheter to dilate ductal stenosis during sialoendoscopy it is possible to dilate a stenotic duct and remove large stones with or without a basket. However, the use of different angiocatheters or dedicated balloons is still empirical. In this pilot study we assessed the feasibility and safety of balloon dilatation of the submandibular gland (Wharton’s duct). We did balloon catheter sialoplasty on four ducts from two fresh adult cadavers. We used a non-compliant dilating balloon catheter 6 mm in diameter at a pressure of 12 × 105 Pa for a total of three minutes and then examined the ducts histologically. There was no damage to the wall of Wharton’s duct. Although this is a small study, we have shown the safety of balloon catheter sialoplasty for the first time as assessed histologically after dilatation of the duct. By virtue of the technique histological assessment is not possible after dilatation in patients. Long-term follow up is clearly required in this rapidly evolving area of surgery. © 2012 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved. Keywords: Balloon dilatation; Wharton’s duct; Sialoendoscopy
Introduction Obstructive sialoadenitis results in painful swelling, usually during mealtimes, and sialolithiasis is the most common aetiology. Other causes include strictures, mucus debris, anatomical abnormalities of the duct, and scar tissue. Recent technological advances have led to the development of several conservative options for the treatment of obstructive salivary disorders of the ducts (sialolithiasis and stenosis) such as external lithotripsy,1 interventional radiology,2 and sialoendoscopy.1,3–5 Nowadays, the use of diagnostic and interventional sialoendoscopy in the major ∗
Corresponding author. Tel.: +39 0706092539; fax: +39 070660622. E-mail address: [email protected] (R. Puxeddu).
salivary glands enable more accurate diagnosis and safer and less invasive surgery with the prospect of sparing the gland and restoring normal function. The use of an expandable balloon catheter to dilate the duct during sialoendoscopy enables stenosis to be treated and bigger stones to be removed with or without a basket, but the use of different angiocatheters or dedicated balloons is still empirical. The principle of treatment is analogous to the dilatation of the lumen of arterial vessels in coronary angioplasty. We aimed to assess the feasibility and safety of balloon catheter sialoplasty on Wharton’s duct in fresh cadavers to standardise its clinical application for the treatment of patients with obstructive sialoadenitis. Detailed histological examination of microslices of the duct was done to verify the effect on the ductal wall.
0266-4356/$ – see front matter © 2012 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.bjoms.2012.06.011
S. Sionis et al. / British Journal of Oral and Maxillofacial Surgery 51 (2013) 228–230
229
Fig. 2. Salivary duct characterised by a wide lumen and a single layer of cuboidal epithelial cells before balloon catheter sialoplasty (haematoxylin and eosin, original magnification × 5).
interruption in the full thickness, or laceration of the mucosal epithelium (Figs. 2 and 3).
Discussion Fig. 1. A submandibular gland next to an inflated balloon catheter after dilatation of the duct.
Material and methods Four Wharton’s ducts were dilated with a balloon catheter for sinuplasty (Lenio® cat, Fentex Medical GmbH, Neuhausen ob Eck, Germany) and removed from two different fresh cadavers during dissection of the major salivary glands. A balloon catheter 16 mm long was introduced into the duct and, once correctly placed to reach the proximal position, was inflated with saline solution to its maximum diameter (6 mm) to a pressure of 12 × 105 Pa using a high-pressure syringe. After leaving the balloon fully inflated for one minute, the pressure was released, and after three dilatations the balloon was removed (Fig. 1). The specimens were fixed in 10% formalin solution for at least one week and every duct was sliced into at least 5 sections to evaluate the difference between the parts that had and had not been dilated. Sections were mounted on histological slides and were stained with haematoxylin and eosin to enable us to look for histopathological changes that suggested damage to the ductal wall.
Dilatation of the main duct of a salivary gland can be useful in the treatment of congenital or post inflammatory stenosis, or when removing a stone. The success rate for endoscopic removal of salivary stones falls from 97% to 35% if the stone is more than 3 mm in diameter.6 The possibility that a part, or the whole of the main duct can be safely dilated increases the indications for conservative treatment of any obstruction. It is now necessary to prove scientifically the feasibility and safety of using dilating balloon catheters so that balloon catheter sialoplasty can be introduced routinely as an adjuvant treatment with sialoendoscopy. The maximum diameter of Wharton’s duct is around 2 mm (mean values varied from 1.5 to 0.5 mm, range
Results Histological examination showed no serious acute damage to the wall of the salivary duct, and only minor changes on the epithelium were observed. We found focal disruption of the epithelium of the lumen only in the duct. We did not find any
Fig. 3. Salivary duct lined by a single layer of cuboidal epithelial cells showing focal disruption of the epithelium after balloon catheter sialoplasty (haematoxylin and eosin, original magnification × 5).
230
S. Sionis et al. / British Journal of Oral and Maxillofacial Surgery 51 (2013) 228–230
2.2–0.2),7 but in obstructive disease when proximal dilatation is caused by salivary stasis or the presence of a stone, further stenosis caused by post inflammatory changes can also be present, although congenital stricture or kinking have been associated.8 If the stone is bigger than the normal diameter of the duct it is impossible to retrieve it with grasping forceps or a basket during sialoendoscopy without the use of laser lithotripsy. Using the expandable balloon catheter to dilate the stenosis or strictures, it is sometimes possible to pass through the narrow area and remove the stone without the need for endoluminal fragmentation. The excessive traction of a retained stone in a narrow duct can strip the duct, which is considered a serious complication of the endoscopic approach.5 Balloon dilatation has largely been used for angioplasty, and in the head and neck for sinuplasty,9 conservative treatment of laryngotracheal stenosis,10 conservative treatment of the nasolacrimal duct,11 and stenosis of the eustachian tube.12 Damage to anatomical structures and to the wall is extremely rare and it is considered safe, but although the use of balloon catheter sialoplasty has been reported we know of no anatomical studies about the standardisation of the technique, or its safety and feasibility. The accidental tearing of the ductal wall, for example, could potentially lead to deep neck abscesses after extravasation of the irrigation solution and debris during sialoendoscopy with potentially medicolegal consequences. The lack of any serious injury to the wall when a 6 mm non-compliant balloon was used in our study confirms that the procedure is feasible and safe, and could be used as a conservative approach for obstructive disease of Wharton’s duct without risking a tear in the wall. Histological examination showed that a non-compliant balloon offers steady dilatation with only minor disruption of the epithelium. The possibility of through-and-through damage of the wall during the procedure is also reduced by the fact that the main duct will have thickened as a consequence of chronic inflammation. We showed this in our scanning electron microscope (SEM – ISI SS40) study on normal and pathological major salivary ducts.13 We recognise that the presence of artefacts from the pathological processing post-mortem in the cadaveric material would alter its resistance to applied forces. However, the cadavers were fresh and the changes post-mortem are usually limited initially to the mucosa. We aimed to stress the duct mechanically to find out if there were any lacerations or serious mucosal damage. In live patients these can induce inflammation or infection deep in the neck after leakage of
endoluminal fluids or debris, and subsequently cause stenosis after operation. Clearly, in a cadaveric study, we cannot evaluate the later effect of dilatation – for example, in possibly inducing inflammation, but in the absence of any tear in the duct, this seems unlikely. It is feasible to dilate the ducts of major salivary glands during sialoendoscopy in cases of narrowing or stenosis that is or is not associated with a large stone. Dilatation of the duct may be the crucial step that allows the stone to be drawn out.
References 1. Nahlieli O, Baruchin AM. Long-term experience with endoscopic diagnosis and treatment of salivary gland inflammatory diseases. Laryngoscope 2000;110:988–93. 2. Drage NA, Brown JE, Escudier MP, McGurk M. Interventional radiology in the removal of salivary calculi. Radiology 2000;214: 139–42. 3. Maresh A, Kutler DI, Kacker A. Sialoendoscopy in the diagnosis and management of obstructive sialadenitis. Laryngoscope 2011;121:495–500. 4. Lari N, Chossegros C, Thiery G, Guyot L, Blanc JL, Marchal F. Sialendoscopy of the salivary glands. Revue de Stomatologie et de Chirurgie Maxillo-Faciale 2008;109:167–71 [in French]. 5. Marchal F, Dulguerov P, Becker M, Barki G, Disant F, Lehmann W. Submandibular diagnostic and interventional sialendoscopy: new procedure for ductal disorders. Annals of Otology, Rhinology and Laryngology 2002;111:27–35. 6. Marchal F, Dulguerov P. Sialolithiasis management: the state of the art. Archives of Otolaryngology – Head and Neck Surgery 2003;129: 951–6. 7. Zenk J, Hosemann WG, Iro H. Diameters of the main excretory ducts of adult human submandibular and parotid gland: a histologic study. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology and Endodontics 1998;85:576–80. 8. Ngu RK, Brown JE, Whaites EJ, Drage NA, Ng SY, Makdissi J. Salivary duct strictures: nature and incidence in benign salivary obstruction. Dentomaxillofacial Radiology 2007;36:63–7. 9. Vaughan WC. Review of balloon sinuplasty. Current Opinion in Otolaryngology & Head and Neck Surgery 2008;16:2–9. 10. Durden F, Sobol SE. Balloon laryngoplasty as a primary treatment for subglottic stenosis. Archives of Otolaryngology – Head and Neck Surgery 2007;133:772–5. 11. Kuchar A, Steinkogler FJ. Antegrade balloon dilatation of nasolacrimal duct obstruction in adults. British Journal of Ophthalmology 2001;85:200–4. 12. Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope 2010;120:1411–6. 13. Testa-Riva F, Congiu T, Lantini MS, Puxeddu R, Riva A. The main excretory duct (Stensen’s) of the human parotid gland: a transmission and scanning electron microscope study. Archives of Histology and Cytology 1995;58:435–48.