The Japanese Journal of Surgery (1992) 22:78-82
~
SURGERYTOOAY © Springer-Verlag 1992
A Silicone Prosthesis for Covering a Large Tracheal Defect in Patients Who Underwent Surgery for Locally Recurrent Aggressive Thyroid Cancer KOICHI ITO, YOSHIHIDEFUJIMOTO, TAKAOOBARA,1 HARUYUKIYANAGISAWA,and TAKASH10HYAMA2 1The Department of Endocrine Surgery, Tokyo Women's Medical College, Tokyo, Japan 2The Department for StomatognathicDysfunction, Fculty of Dentistry, Tokyo Medical and Dental University, Tokyo, Japan
Abstract: Following the usual sleeve or windowresection of the trachea, reconstruction of the trachea can be carried out without difficulty in patients with aggressive thyroid cancer. When the cancer recurs locally in those patients, reoperation often yields a large tracheal defect, for which a commercially available tracheostomy cannula or a silicone-tube does not fit. By using a technique in the maxillofacial prosthetic field, it has become possible to make a new type of prosthesis which is more comfortable and acceptable to the patients with a large tracheal defect. A new type of silicone rubber prosthesis is made individually from the mold of each patient. Several appointments are required for adjustments by the chair side. It must tightly obstruct the tracheostomy stoma so that the patient can easily breathe, speak and take oral fluids. Patients can easily remove and replace this device by themselves and care of the prosthesis is easy. The practical use of this type of prosthesis in three patients is reported herein. Key Words: thyroid cancer, tracheal invasion, silicone prosthesis
a one stage end to end anastomosis of the trachea is impossible or impractical. In these situations, a permanent or transient tracheostomy made by suturing the tracheal defect to the cervical skin incision line is the treatment of choice. In such patients, even with laryngeal preservation, phonation may be insufficient when an ordinary speech cannula or hand-made tracheal substitute is applied because of the wide range of the tracheal defect, preventing tight contact and permitting unacceptable air leakage. Using a technique originally adopted in the field of jaw and facial reconstructions attempts were made to produce a detachable prosthesis which would fill the tracheal defect, tailored to individual patients. A silicone-rubber prosthesis makes it possible to tightly close the tracheal defect without interfering with neck movement. Three patients treated with this method are reported, along with the characteristics of the prosthesis and its use.
Introduction In patients with tracheal invasion of thyroid carcinoma, an aggressive resection involving the trachea has recently been accepted as the treatment of choice. ~ A one-stage reconstruction of the trachea using an end-toend anastomosis after a sleeve resection of the involved trachea is ideal. However, most of the patients with extensive carcinoma invasion of the trachea are either those with recurrent cancer involving the trachea after a previous tracheal resection, or those with a concurrent esophageal invasion of thyroid cancer, in whom Reprint request to: Koichi Ito, MD, The Department of Endocrine Surgery, Tokyo Women's Medical College, 8-1 Kawadacho, Shiniuku-ku, Tokyo 162, Japan This paper was presented at the Toronto meeting of the International Association of Endocrine Surgeons in 1989 (Received for publication on Aug. 22, 1990)
Preparation of the Prosthesis A suitable material to make the prosthesis is silicone rubber, SILASTIC MDX-4210, produced by Dow Coming Corporation, Michigan, USA, which has originally been used for jaw and facial reconstruction. The process to make this prosthesis is outlined as follows. 1) Using silicone impression material designed for dental reconstructive use, the morphology of a tracheal lumen and surrounding anatomy is recorded. 2) An impression case is obtained using a plaster mold and the prosthesis cast by injecting the prosthesismaterial into this mold. 3) Final adjustments of the prosthesis are made after a preliminary fitting application to the patient. It takes approximately three weeks to complete the prosthesis and the expense amounts to about 70,000yen (US$450).
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect This prosthesis consists of the two portions (Fig. 1). The internal portion is inserted intratracheally (5 mm1 cm in depth), and the external portion attached to the skin of the neck, fitting the fistula. Compared with the conventional commercial cannula, this prosthesis (Figs. 2a and 2b) has precise adaptability, and allows satisfactory phonation due to its preparation according to the size and exact anatomy of the tracheal defect in the individual patient. Adherence of airway secretions to this prosthesis is minimal. Since the material provides a suitable elasticity resembling that of living tissue, it does not interfere with neck movement, minimizing application discomfort and making it possible for the patient to easily apply, remove and wash the appliance. In patients who have undergone tracheal resection, a follow-up examination is usually required for a certain period to confirm that there is no further local recurrence. Direct visualization of the tracheal lumen is possible when the prosthesis is detached. This is an additional advantage of its use in patients who are at a risk of recurrence.
79
Fig. 1. The silicone-rubber prosthesis made for covering a large tracheal defect in Case 1. The material is SILASTIC MDX-4210, produced by Dow Coming Corporation, USA. a Internal portion. This portion is inserted intratracheally (5 mm-1 cm in depth), b External portion
b Fig. 2. Compared with the conventional commercial cannula, this prosthesis has precise adaptability, allowing satisfactory phonation, a Case 2. b Case 3
80
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect
Fig. 3. Cervical CT scan of Case 1 showing a tumor mass measuring 5 x 5cm (arrows) at the site of the previous operation. The tumor mass was infiltrating and compressing the trachea
Case Reports Case 1 A 55 year old male underwent palliative resection of the left lobe of the thyroid for papillary carcinoma of the thyroid elsewhere in May, 1981. In August, 1985, he began to experience dysphagia and in July, 1986, an endoscopic examination of the cervical esophagus revealed a recurrence of thyroid carcinoma within the esophageal lumen. The patient was referred to us in September, 1986. On admission, the patient's general condition was good. The upper GI series showed an exophytic lesion, 5 cm in diameter, in the cervical esophagus. Fiberscopic laryngoscopy showed a submucosal elevation with abnormal mucosal erythema in the trachea. Cervical CT scan also showed a tumor mass measuring 5 x 5 cm at the site of the previous operation which was infiltrating and compressing the trachea (Fig. 3). Resection of the recurrent tumor was performed in October, 1986 with partial resection of the cervical esophagus, including the 2.5 x 3 cm interluminar tumor, combined with a three ring sleeve resection of the trachea. In the upper mediastinum, massive metastasis was noted in the pretracheal and left paratracheal lymph nodes, which were completely dissected. The esophageal defect was transversely sutured while the tracheal defect was closed by an end to end anastomosis. As impaired blood supply to the trachea was anticipated because of the extensive upper mediastinal dissection, a tracheostomy was performed 1 cm caudal to the anastomotic site. Histopathological examination revealed papillary carcinoma arising from the lower part of the left thyroid
Fig. 4. Local findings after the operation in Case 1 showing a large external tracheocutaneous fistula measuring 27 x 14 mm lobe, infiltrating both the tracheal and esophageal mucosae. Postoperatively, an infection caused dehiscence of the tracheal anastomosis, finally resulting in a large external tracheocutaneous fistula measuring 27 x 14ram (Fig. 4). Since the upper portion of the right thyroid lobe remained, a euthyroid state was maintained without thyroid hormone supplementation. The serum calcium level returned to normal after a three month treatment with calcium and 1-hydroxy cholcalciferol. A prosthesis was made and the patient was able to return to his previous life style, including business work, because of the improvement in phonation due to the prosthesis. At the present time, three years and six months following surgery, there is no sign of local recurrence or distant metastasis. Case 2 A 54 year old male presented in 1978 with a tumor in the right side of the neck. In 1979, a biopsy was performed and a diagnosis of thyroid cancer was made elsewhere, although no treatment was initiated. In
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect June, 1982, the patient visited our clinic with symptoms of hemoptysis and hoarseness of one month's duration. On July 7, 1982, a total thyroidectomy with a sleeve resection of three tracheal rings and bilateral modified neck dissections were performed for thyroid cancer infiltrating the trachea. Macroscopic examination of the resected specimen showed a main tumor located in the middle and lower part of the left lobe of the thyroid invading the trachea and through to the lumen at the level of the second and third tracheal rings. Histopathological examination demonstrated tracheal infiltration of papillary carcinoma. The surgical wound healed in one stage without any complication and was followed by an uneventful recovery. In April, 1986, the patient again complained of hemoptysis and fiberscopic laryngoscopy showed an abnormal area of mucosal erythema with a polypoid elevation about 2 cm below the epiglottis, probably at the site of the previous end to end anastomosis. The bilateral vocal cords moved normally. Cervical CT scan demonstrated tumorous infiltration into the tracheal lumen. Under a diagnosis of intratracheal recurrence of papillary carcinoma, a partial resection of a two ring portion of the trachea was performed. At this reoperation, tracheal mobilization was difficult due to fibrous adhesions and there was a risk of further recurrence in the future, so that a one stagetracheal anastomosis was not performed. Instead, the skin incision was sutured to the edge of the tracheal defect to form a permanent external tracheal fistula approximately 28 x 12 mm in size. Postoperatively, the patient was followed with no signs of tumor recurrence. Adequate phonation was possible using a specifically devised silicone prosthesis (Fig. 2a). Two years and nine months after the reoperation, the external tracheal fistula was closed under local anesthesia. The subsequent course has been uneventful, without local recurrence or remote metastasis. Case 3 A 50 year old female underwent a right thyroid lobectomy for carcinoma of the thyroid elsewhere in 1975. In 1976, lymph nodes harboring metastatic lesions were removed in the left side of the neck. In 1983, tumor recurrence occurred again in the neck and was removed with a diagnosis of follicular carcinoma being made. In March 1988, a tumor again recurred in the neck and the patient was referred to us. A chest X-ray showed multiple nodular metastatic lesions in the bilateral lung fields. Fiberscopic laryngoscopy showed a tumor protruding into the tracheal lumen about 6 cm below the epiglottis with hemorrhage from the mucosal surface. Cervical CT scan also demonstrated tumor infiltration into the tracheal lumen.
81 In April, 1988, an operation was performed. The recurrent tumor was removed including the left side of the trachea where invasion occurred and, anticipating 1-131 therapy for the distant metastasis, the remaining right normal lobe of the" thyroid was removed. Resection of the trachea involved ten rings, resulting in a tracheal defect of 46 x 14 mm and, since a primary closure was impossible, a tracheo-cutaneous fistula was constructed. In the resected specimen, a tumor measuring 20 x 18mm, protruding into the tracheal lumen was found producing the histological diagnosis of follicular carcinoma of the thyroid. Six months after surgery, an 1-131 scintigraphy demonstrated metastasis to the lung and pelvis. Radiation therapy using 1-131 and chemotherapy were performed. During the course of treatment, the prosthesis (Fig. 2b) was useful not only for phonation in good quality, but also for the prevention of contamination of the rooms by isotope leakage from the tracheal incision site during 1-131 isotope test and treatment.
Discussion
Since the thyroid is directly attached to the trachea, poorly differentiated carcinoma of the thyroid occasionaly infiltrates the trachea, causing intratracheal bleeding and/or tracheal stenosis, and occurs in males usually over the age of 40 and in females over the age of 50.1 Infiltration of the trachea by differentiated thyroid cancer is surgically treated with a variety of techniques including local abrasion, cautery, resection of the cartilagenous layer sparing the mucosa, resection of all tracheal layers of a limited area (a "window" resection) and a sleeve resection, depending on the spread and depth of involvement. In cases in which the infiltration reaches the mucosa, a window resection or sleeve resection is required to achieve radical resection. Aggressive tracheal resection has recently been adopted, particularly in Japan. 1-7 Various methods of airway reconstruction and tracheoplasty have been devised. As a result, the resectable range has been enlarged and cases with indications for direct end-to-end anastomosis have increased with resection of even ten tracheal rings being reported. 3,8,9 However, in cases of reoperation for recurrent carcinoma of the thyroid with marked proliferative and infiltrative potencies and cases of immobility of the trachea due to firm adhesions caused by a previous operation, as well as those cases which require simultaneous esophageal resection and those with circulatory disturbances of the trachea caused by wide paratracheal dissection for marked involvement of lymphnodes by metastatic lesions, a one-stage reconstruction of the trachea is frequently impossible.
82 Under these circumustances, a large tracheal defect remains, causing difficulty for the patients in functions such as phonation and expectoration. As no commercially-available speech cannulae fit adequately, attempts to produce various tracheal substitutes have been made, but do not achieve the air tight seal necessary for adequate phonation. Trials to make a prosthesis using dental materials have already been reported, 1°-13 however, a prosthesis applied to the external tracheo-cutaneous fistula requires the following properties. 1) A tight fit to the external fistula site to prevent an intratracheal air leakage. 2) Since the neck is a rather mobile portion of the body, the prosthesis should not restrict neck motion. 3) Application and removal of the prosthesis by the patient can easily be done and the prosthesis should be easily washable. 4) Adherence of airway secretions to the prosthesis should be minimal. 5) No cutaneous hypersensitivity to the material should be experienced and the material used in the prosthesis should be harmless to patients. 6) The price is not too expensive. In order to meet these requirements, we produced a prosthesis for intratracheal insertion using a material originally used for jaw and facial reconstruction (SILASTIC MDX-4210, Dow Corning, USA). In this prosthesis, the internal portion, which is inserted intratracheally, and the external portion, which is tightly attached to the skin of the neck, fitted the fistula. The internal portion serves as a substitute for the anterior tracheal wall and prevents dislodgemerit, whereas the external portion increases the area of contact and prevents air leakage. In its application to the three cases we reported herein, the advantages of this prototype prosthesis consisted of 1) satisfactory phonation without breathing problems and with a marked prolongation of the duration of maximum phonation, 2) minimal discomfort and little interference with neck motion because of adequate elasticity of the material and 3) ease of application, removal and washing by the patient. Our patients have been quite satisfied with the performance of this appliance.
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect Our prosthesis is useful not only as a permanent device, but also for temporary use, as in case 2, prior to closure of the tracheocutaneous fistula. It also prevents the leakage of isotopic materials from the tracheal opening during diagnostic nuclear medicine tests and radioisotope therapy.
References
1. Fujimoto Y, Obara T, Kodama T, Ito Y, Yashiro T, Yamashita T, Nozaki M, Suzuki K (1986) Aggressive surgical approach for locally invasive papillary carcinoma of the thyroid in patients over forty-five years of age. Surgery 100:1098-1107 2. Djalian M, Beahrs OH, Devine KD, Weiland LH, DeSanto LW (1974) Intraluminal involvement of the larynx and trachea by thyroid cancer. Am J Surg 128:500-504 3. Ishihara T, Yamazaki S, Kobayashi K, Inoue H, Fukai S, Ito K, Mimura T (1982) Resection-of the trachea infiltrated by thyroid carcinoma. Ann Surg 195:496-500 4. Grillo HC (1965) Circumferential resection and reconstruction of the mediastinal and cervical trachea. Ann Surg 162:374-388 5. Ebihara S, Saito H, Yoshida H0 Ono I, Konno T, Oyamada H, Terui S (1979) A new technique for reconstruction of the cervical trachea for the treatment of thyroid cancer with tracheal invasion. Jpn J Clin Oncol 9:247-254 6. Gadiner LJ, Sasaki CT, Hermansen K, Suger J, Geha AS (1981) Tracheal obstruction by recurrent thyroid carcinoma. Otolaryngol Head and Neck. Surg 89:965-968 7. William EN, Paul JP, Hooshang S (1976) Prosthetic reconstruction of the trachea and carina. J Thorac Cardiovasc Surg 72:525-538
8. Dedo HH, Fishman NH (1969) Laryngeal release and sleeve resection for tracheal stenosis. Ann Otol Rhinol Laryngol 78: 285-296 9. Glillo HC (1973) Reconstruction of the trachea. Thorax 28:667679 10. John B, Thomas AC, David NF (1979) Maxillofacial rehabilitation. St. Louis: CV Mosby Company pp 503-540 11. Herbert S, Alfred SK, Jean K (1969) Tracheostomy prostheses. J Prosthent Dent 22:84-87 12. Kasai N, Uchida M, Kamata N, Kato T, Noguchi A (1982) Surgical treatment for advanced or locally recurrent thyroid cancer. (in Japanese) Shujutsu 36:1563-1570 13. Sasaki J (1986) The 9th clinical conference-Recurrence and metastasis of well-differentiated thyroid cancer. Endocrine Surgery (in Japanese) (J Jpn Assoc Endocrine Surg) 3: 306-324
~
SURGERYTOOAY © Springer-Verlag 1992
A Silicone Prosthesis for Covering a Large Tracheal Defect in Patients Who Underwent Surgery for Locally Recurrent Aggressive Thyroid Cancer KOICHI ITO, YOSHIHIDEFUJIMOTO, TAKAOOBARA,1 HARUYUKIYANAGISAWA,and TAKASH10HYAMA2 1The Department of Endocrine Surgery, Tokyo Women's Medical College, Tokyo, Japan 2The Department for StomatognathicDysfunction, Fculty of Dentistry, Tokyo Medical and Dental University, Tokyo, Japan
Abstract: Following the usual sleeve or windowresection of the trachea, reconstruction of the trachea can be carried out without difficulty in patients with aggressive thyroid cancer. When the cancer recurs locally in those patients, reoperation often yields a large tracheal defect, for which a commercially available tracheostomy cannula or a silicone-tube does not fit. By using a technique in the maxillofacial prosthetic field, it has become possible to make a new type of prosthesis which is more comfortable and acceptable to the patients with a large tracheal defect. A new type of silicone rubber prosthesis is made individually from the mold of each patient. Several appointments are required for adjustments by the chair side. It must tightly obstruct the tracheostomy stoma so that the patient can easily breathe, speak and take oral fluids. Patients can easily remove and replace this device by themselves and care of the prosthesis is easy. The practical use of this type of prosthesis in three patients is reported herein. Key Words: thyroid cancer, tracheal invasion, silicone prosthesis
a one stage end to end anastomosis of the trachea is impossible or impractical. In these situations, a permanent or transient tracheostomy made by suturing the tracheal defect to the cervical skin incision line is the treatment of choice. In such patients, even with laryngeal preservation, phonation may be insufficient when an ordinary speech cannula or hand-made tracheal substitute is applied because of the wide range of the tracheal defect, preventing tight contact and permitting unacceptable air leakage. Using a technique originally adopted in the field of jaw and facial reconstructions attempts were made to produce a detachable prosthesis which would fill the tracheal defect, tailored to individual patients. A silicone-rubber prosthesis makes it possible to tightly close the tracheal defect without interfering with neck movement. Three patients treated with this method are reported, along with the characteristics of the prosthesis and its use.
Introduction In patients with tracheal invasion of thyroid carcinoma, an aggressive resection involving the trachea has recently been accepted as the treatment of choice. ~ A one-stage reconstruction of the trachea using an end-toend anastomosis after a sleeve resection of the involved trachea is ideal. However, most of the patients with extensive carcinoma invasion of the trachea are either those with recurrent cancer involving the trachea after a previous tracheal resection, or those with a concurrent esophageal invasion of thyroid cancer, in whom Reprint request to: Koichi Ito, MD, The Department of Endocrine Surgery, Tokyo Women's Medical College, 8-1 Kawadacho, Shiniuku-ku, Tokyo 162, Japan This paper was presented at the Toronto meeting of the International Association of Endocrine Surgeons in 1989 (Received for publication on Aug. 22, 1990)
Preparation of the Prosthesis A suitable material to make the prosthesis is silicone rubber, SILASTIC MDX-4210, produced by Dow Coming Corporation, Michigan, USA, which has originally been used for jaw and facial reconstruction. The process to make this prosthesis is outlined as follows. 1) Using silicone impression material designed for dental reconstructive use, the morphology of a tracheal lumen and surrounding anatomy is recorded. 2) An impression case is obtained using a plaster mold and the prosthesis cast by injecting the prosthesismaterial into this mold. 3) Final adjustments of the prosthesis are made after a preliminary fitting application to the patient. It takes approximately three weeks to complete the prosthesis and the expense amounts to about 70,000yen (US$450).
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect This prosthesis consists of the two portions (Fig. 1). The internal portion is inserted intratracheally (5 mm1 cm in depth), and the external portion attached to the skin of the neck, fitting the fistula. Compared with the conventional commercial cannula, this prosthesis (Figs. 2a and 2b) has precise adaptability, and allows satisfactory phonation due to its preparation according to the size and exact anatomy of the tracheal defect in the individual patient. Adherence of airway secretions to this prosthesis is minimal. Since the material provides a suitable elasticity resembling that of living tissue, it does not interfere with neck movement, minimizing application discomfort and making it possible for the patient to easily apply, remove and wash the appliance. In patients who have undergone tracheal resection, a follow-up examination is usually required for a certain period to confirm that there is no further local recurrence. Direct visualization of the tracheal lumen is possible when the prosthesis is detached. This is an additional advantage of its use in patients who are at a risk of recurrence.
79
Fig. 1. The silicone-rubber prosthesis made for covering a large tracheal defect in Case 1. The material is SILASTIC MDX-4210, produced by Dow Coming Corporation, USA. a Internal portion. This portion is inserted intratracheally (5 mm-1 cm in depth), b External portion
b Fig. 2. Compared with the conventional commercial cannula, this prosthesis has precise adaptability, allowing satisfactory phonation, a Case 2. b Case 3
80
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect
Fig. 3. Cervical CT scan of Case 1 showing a tumor mass measuring 5 x 5cm (arrows) at the site of the previous operation. The tumor mass was infiltrating and compressing the trachea
Case Reports Case 1 A 55 year old male underwent palliative resection of the left lobe of the thyroid for papillary carcinoma of the thyroid elsewhere in May, 1981. In August, 1985, he began to experience dysphagia and in July, 1986, an endoscopic examination of the cervical esophagus revealed a recurrence of thyroid carcinoma within the esophageal lumen. The patient was referred to us in September, 1986. On admission, the patient's general condition was good. The upper GI series showed an exophytic lesion, 5 cm in diameter, in the cervical esophagus. Fiberscopic laryngoscopy showed a submucosal elevation with abnormal mucosal erythema in the trachea. Cervical CT scan also showed a tumor mass measuring 5 x 5 cm at the site of the previous operation which was infiltrating and compressing the trachea (Fig. 3). Resection of the recurrent tumor was performed in October, 1986 with partial resection of the cervical esophagus, including the 2.5 x 3 cm interluminar tumor, combined with a three ring sleeve resection of the trachea. In the upper mediastinum, massive metastasis was noted in the pretracheal and left paratracheal lymph nodes, which were completely dissected. The esophageal defect was transversely sutured while the tracheal defect was closed by an end to end anastomosis. As impaired blood supply to the trachea was anticipated because of the extensive upper mediastinal dissection, a tracheostomy was performed 1 cm caudal to the anastomotic site. Histopathological examination revealed papillary carcinoma arising from the lower part of the left thyroid
Fig. 4. Local findings after the operation in Case 1 showing a large external tracheocutaneous fistula measuring 27 x 14 mm lobe, infiltrating both the tracheal and esophageal mucosae. Postoperatively, an infection caused dehiscence of the tracheal anastomosis, finally resulting in a large external tracheocutaneous fistula measuring 27 x 14ram (Fig. 4). Since the upper portion of the right thyroid lobe remained, a euthyroid state was maintained without thyroid hormone supplementation. The serum calcium level returned to normal after a three month treatment with calcium and 1-hydroxy cholcalciferol. A prosthesis was made and the patient was able to return to his previous life style, including business work, because of the improvement in phonation due to the prosthesis. At the present time, three years and six months following surgery, there is no sign of local recurrence or distant metastasis. Case 2 A 54 year old male presented in 1978 with a tumor in the right side of the neck. In 1979, a biopsy was performed and a diagnosis of thyroid cancer was made elsewhere, although no treatment was initiated. In
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect June, 1982, the patient visited our clinic with symptoms of hemoptysis and hoarseness of one month's duration. On July 7, 1982, a total thyroidectomy with a sleeve resection of three tracheal rings and bilateral modified neck dissections were performed for thyroid cancer infiltrating the trachea. Macroscopic examination of the resected specimen showed a main tumor located in the middle and lower part of the left lobe of the thyroid invading the trachea and through to the lumen at the level of the second and third tracheal rings. Histopathological examination demonstrated tracheal infiltration of papillary carcinoma. The surgical wound healed in one stage without any complication and was followed by an uneventful recovery. In April, 1986, the patient again complained of hemoptysis and fiberscopic laryngoscopy showed an abnormal area of mucosal erythema with a polypoid elevation about 2 cm below the epiglottis, probably at the site of the previous end to end anastomosis. The bilateral vocal cords moved normally. Cervical CT scan demonstrated tumorous infiltration into the tracheal lumen. Under a diagnosis of intratracheal recurrence of papillary carcinoma, a partial resection of a two ring portion of the trachea was performed. At this reoperation, tracheal mobilization was difficult due to fibrous adhesions and there was a risk of further recurrence in the future, so that a one stagetracheal anastomosis was not performed. Instead, the skin incision was sutured to the edge of the tracheal defect to form a permanent external tracheal fistula approximately 28 x 12 mm in size. Postoperatively, the patient was followed with no signs of tumor recurrence. Adequate phonation was possible using a specifically devised silicone prosthesis (Fig. 2a). Two years and nine months after the reoperation, the external tracheal fistula was closed under local anesthesia. The subsequent course has been uneventful, without local recurrence or remote metastasis. Case 3 A 50 year old female underwent a right thyroid lobectomy for carcinoma of the thyroid elsewhere in 1975. In 1976, lymph nodes harboring metastatic lesions were removed in the left side of the neck. In 1983, tumor recurrence occurred again in the neck and was removed with a diagnosis of follicular carcinoma being made. In March 1988, a tumor again recurred in the neck and the patient was referred to us. A chest X-ray showed multiple nodular metastatic lesions in the bilateral lung fields. Fiberscopic laryngoscopy showed a tumor protruding into the tracheal lumen about 6 cm below the epiglottis with hemorrhage from the mucosal surface. Cervical CT scan also demonstrated tumor infiltration into the tracheal lumen.
81 In April, 1988, an operation was performed. The recurrent tumor was removed including the left side of the trachea where invasion occurred and, anticipating 1-131 therapy for the distant metastasis, the remaining right normal lobe of the" thyroid was removed. Resection of the trachea involved ten rings, resulting in a tracheal defect of 46 x 14 mm and, since a primary closure was impossible, a tracheo-cutaneous fistula was constructed. In the resected specimen, a tumor measuring 20 x 18mm, protruding into the tracheal lumen was found producing the histological diagnosis of follicular carcinoma of the thyroid. Six months after surgery, an 1-131 scintigraphy demonstrated metastasis to the lung and pelvis. Radiation therapy using 1-131 and chemotherapy were performed. During the course of treatment, the prosthesis (Fig. 2b) was useful not only for phonation in good quality, but also for the prevention of contamination of the rooms by isotope leakage from the tracheal incision site during 1-131 isotope test and treatment.
Discussion
Since the thyroid is directly attached to the trachea, poorly differentiated carcinoma of the thyroid occasionaly infiltrates the trachea, causing intratracheal bleeding and/or tracheal stenosis, and occurs in males usually over the age of 40 and in females over the age of 50.1 Infiltration of the trachea by differentiated thyroid cancer is surgically treated with a variety of techniques including local abrasion, cautery, resection of the cartilagenous layer sparing the mucosa, resection of all tracheal layers of a limited area (a "window" resection) and a sleeve resection, depending on the spread and depth of involvement. In cases in which the infiltration reaches the mucosa, a window resection or sleeve resection is required to achieve radical resection. Aggressive tracheal resection has recently been adopted, particularly in Japan. 1-7 Various methods of airway reconstruction and tracheoplasty have been devised. As a result, the resectable range has been enlarged and cases with indications for direct end-to-end anastomosis have increased with resection of even ten tracheal rings being reported. 3,8,9 However, in cases of reoperation for recurrent carcinoma of the thyroid with marked proliferative and infiltrative potencies and cases of immobility of the trachea due to firm adhesions caused by a previous operation, as well as those cases which require simultaneous esophageal resection and those with circulatory disturbances of the trachea caused by wide paratracheal dissection for marked involvement of lymphnodes by metastatic lesions, a one-stage reconstruction of the trachea is frequently impossible.
82 Under these circumustances, a large tracheal defect remains, causing difficulty for the patients in functions such as phonation and expectoration. As no commercially-available speech cannulae fit adequately, attempts to produce various tracheal substitutes have been made, but do not achieve the air tight seal necessary for adequate phonation. Trials to make a prosthesis using dental materials have already been reported, 1°-13 however, a prosthesis applied to the external tracheo-cutaneous fistula requires the following properties. 1) A tight fit to the external fistula site to prevent an intratracheal air leakage. 2) Since the neck is a rather mobile portion of the body, the prosthesis should not restrict neck motion. 3) Application and removal of the prosthesis by the patient can easily be done and the prosthesis should be easily washable. 4) Adherence of airway secretions to the prosthesis should be minimal. 5) No cutaneous hypersensitivity to the material should be experienced and the material used in the prosthesis should be harmless to patients. 6) The price is not too expensive. In order to meet these requirements, we produced a prosthesis for intratracheal insertion using a material originally used for jaw and facial reconstruction (SILASTIC MDX-4210, Dow Corning, USA). In this prosthesis, the internal portion, which is inserted intratracheally, and the external portion, which is tightly attached to the skin of the neck, fitted the fistula. The internal portion serves as a substitute for the anterior tracheal wall and prevents dislodgemerit, whereas the external portion increases the area of contact and prevents air leakage. In its application to the three cases we reported herein, the advantages of this prototype prosthesis consisted of 1) satisfactory phonation without breathing problems and with a marked prolongation of the duration of maximum phonation, 2) minimal discomfort and little interference with neck motion because of adequate elasticity of the material and 3) ease of application, removal and washing by the patient. Our patients have been quite satisfied with the performance of this appliance.
K. Ito et al.: Silicone Prosthesis for a Tracheal Defect Our prosthesis is useful not only as a permanent device, but also for temporary use, as in case 2, prior to closure of the tracheocutaneous fistula. It also prevents the leakage of isotopic materials from the tracheal opening during diagnostic nuclear medicine tests and radioisotope therapy.
References
1. Fujimoto Y, Obara T, Kodama T, Ito Y, Yashiro T, Yamashita T, Nozaki M, Suzuki K (1986) Aggressive surgical approach for locally invasive papillary carcinoma of the thyroid in patients over forty-five years of age. Surgery 100:1098-1107 2. Djalian M, Beahrs OH, Devine KD, Weiland LH, DeSanto LW (1974) Intraluminal involvement of the larynx and trachea by thyroid cancer. Am J Surg 128:500-504 3. Ishihara T, Yamazaki S, Kobayashi K, Inoue H, Fukai S, Ito K, Mimura T (1982) Resection-of the trachea infiltrated by thyroid carcinoma. Ann Surg 195:496-500 4. Grillo HC (1965) Circumferential resection and reconstruction of the mediastinal and cervical trachea. Ann Surg 162:374-388 5. Ebihara S, Saito H, Yoshida H0 Ono I, Konno T, Oyamada H, Terui S (1979) A new technique for reconstruction of the cervical trachea for the treatment of thyroid cancer with tracheal invasion. Jpn J Clin Oncol 9:247-254 6. Gadiner LJ, Sasaki CT, Hermansen K, Suger J, Geha AS (1981) Tracheal obstruction by recurrent thyroid carcinoma. Otolaryngol Head and Neck. Surg 89:965-968 7. William EN, Paul JP, Hooshang S (1976) Prosthetic reconstruction of the trachea and carina. J Thorac Cardiovasc Surg 72:525-538
8. Dedo HH, Fishman NH (1969) Laryngeal release and sleeve resection for tracheal stenosis. Ann Otol Rhinol Laryngol 78: 285-296 9. Glillo HC (1973) Reconstruction of the trachea. Thorax 28:667679 10. John B, Thomas AC, David NF (1979) Maxillofacial rehabilitation. St. Louis: CV Mosby Company pp 503-540 11. Herbert S, Alfred SK, Jean K (1969) Tracheostomy prostheses. J Prosthent Dent 22:84-87 12. Kasai N, Uchida M, Kamata N, Kato T, Noguchi A (1982) Surgical treatment for advanced or locally recurrent thyroid cancer. (in Japanese) Shujutsu 36:1563-1570 13. Sasaki J (1986) The 9th clinical conference-Recurrence and metastasis of well-differentiated thyroid cancer. Endocrine Surgery (in Japanese) (J Jpn Assoc Endocrine Surg) 3: 306-324
