Acta Oto-Laryngologica. 2013; 133: 1317–1321

ORIGINAL ARTICLE

Secondary insertion of Provox2 using an endotracheal tube

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KIYOAKI TSUKAHARA, KAZUHIRO NAKAMURA, RAY MOTOHASHI, MINORU ENDO, HIROKI SATO & MAMORU SUZUKI Department of Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan

Abstract Conclusion: A procedure with no exploratory puncture using an endotracheal tube, sharp-tipped trocar, flexible fiberscope, and flexible guidewire is useful for inserting the Provox2 prosthesis. Objectives: The purpose of the present study was to examine the necessity of exploratory puncture in consideration of operating time, complications, and voice rehabilitation. Methods: Insertion of the Provox2 was conducted using an endotracheal tube, sharp-tipped trocar, flexible fiberscope, and flexible guidewire under general anesthesia. This was performed in conjunction with exploratory puncture in the first 7 patients, and without exploratory puncture in the following 15 patients. Results: Operating time was 10 min in the group with exploratory puncture and 6 min in the group without exploratory puncture. Although a shorter size had to be substituted in one patient without exploratory puncture on the day following the procedure due to difficulty with eating, no complications due to the procedure were observed in any patients. Speech production was possible in all patients on the following day.

Keywords: Tracheoesophageal shunt, exploratory puncture, voice rehabilitation, voice prosthesis

Introduction Tracheoesophageal fistula formation is a method used for voice rehabilitation following total laryngectomy. The Provox2, a voice prosthesis used for this purpose, can be left in place for long periods of time [1]. In Holland, primary insertion is the main procedure, whereas secondary insertion, in which insertion is not conducted directly after total laryngectomy, is more common in Japan. Hilgers et al. [1] have reported on secondary insertion using a rigid esophagoscope, sharp-tipped trocar, and flexible guidewire. However, the effects of postoperative cicatricial rigidity of the neck and radiotherapy can make insertion using a rigid esophagoscope difficult in some cases and a procedure using an endotracheal tube has been reported [2–4]. We initially used the method reported by Suda et al. [4], but then started using a modified procedure in which insertion is conducted without exploratory insertion, as we had determined exploratory insertion

before trocar insertion to be unnecessary. The objective of the present study was to retrospectively examine whether insertion of Provox2 using an endotracheal tube was useful even for patients with a history of radiotherapy and whether differences existed between performance and nonperformance of exploratory insertion with regard to operating time and complications. Material and methods Subjects in the present study were selected from 23 patients who had undergone secondary insertion of Provox2 at Tokyo Medical University, Hachioji Medical Center from April 2008 to September 2012. We eliminated 1 patient who had undergone neck skin reconstruction using the pectoralis major muscle and selected the remaining 22 (19 men, 3 women) as subjects. Cases, including disease treatments, are shown in Table I. The mean age was 67 years (range 57–80 years). The underlying pathology was

Correspondence: Kiyoaki Tsukahara, Tokyo Medical University Hachioji Medical Center, 163 Tatemachi, Hachioji, Tokyo 193-0998, Japan. Tel: +81 42 665 5611. Fax: +81 42 665 5639. E-mail: [email protected]

(Received 28 May 2013; accepted 4 July 2013) ISSN 0001-6489 print/ISSN 1651-2251 online  2013 Informa Healthcare DOI: 10.3109/00016489.2013.824610

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Table I. Case details. Case no.

Age (years)

Sex

Disease

Operation procedures

Radiotherapy

Exploratory puncture

Operation time (min)

1

63

Male

HPC

TPL + JR

48 Gy

+

12

2

70

Male

HPC

TPL + JR



+

10

3

77

Male

LC

TL

60 Gy

+

20

4

64

Male

HPC

TPL + JR

50 Gy + CDDP

+

17

5

61

Male

HPC, EC

TPL + JR



+

8

6

62

Male

LC

TL



+

11

7

64

Male

HPC, EC

TPL + SR + JR



+

26

8

73

Male

HPC

TPL + JR





9

9

70

Male

HPC

TPL + JR

50 Gy



12

10

63

Male

HPC

TPL + JR

50 Gy + CDDP



17

11

69

Male

LC

TL

60 Gy + TPF



10

12

68

Male

HPC

TPL + JR

50 Gy + CDDP



7

13

76

Female

TC

TPL + JR





6

14

57

Male

HPC

TPL + JR





7

15

65

Male

HPC

TPL + JR





8

16

68

Female

HPC

TPL + JR





6

17

72

Male

HPC

TPL + JR





5

18

57

Male

HPC

TPL + JR

50 Gy + CDDP



15

19

64

Male

LC

TL

50 Gy + CDDP



13

20

59

Male

LC

TL

50 Gy + CDDP



8

21

65

Male

LC

TL





9

22

80

Female

HPC

TPLE + JR





7

CDDP, Cisplatin; EC, esophageal carcinoma; HPC, hypopharyngeal carcinoma; JR, free jejunum reconstruction; LC, laryngeal carcinoma; SR, stomach roll reconstruction; TC, thyroid carcinoma; TPF, Docetaxel, Cisplatin, 5-fluorouracil; TPL, total pharyngolaryngectomy.

hypopharyngeal cancer in 13 cases, hypopharyngeal cancer and esophageal cancer in 2 cases, laryngeal cancer in 6 cases, and thyroid cancer in 1 case. The procedure used to treat these diseases was total laryngectomy in 6 cases, pharyngolaryngectomy with free jejunal autograft reconstruction in 15 cases, and pharyngolaryngectomy with stomach roll reconstruction in 1 case. Three patients were treated using radiotherapy alone, six were treated with radiotherapy combined with cisplatin, and one was treated with radiotherapy in combination with docetaxel, 5-fluorouracil, and cisplatin. General anesthesia was used for all patients. Surgery was carried out by repeatedly removing the ventilation tube, conducting the surgical procedure for 1–2 min in a state of apnea, and then reinserting the ventilation tube under the instruction of the anesthesiologist to achieve reventilation. Transorally, the endotracheal tube was inserted (Figure 1) and the tube was checked by palpation at the tracheostoma (Figure 2). An endotracheal tube of size 6.5–8.0 was used, depending on the patient.

Figure 1. The endotracheal tube inserted transorally.

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Secondary insertion of Provox2 using an endotracheal tube

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indicating the possibility of no difference. As the result of Wilcoxon’s rank-sum test was p = 0.501, no significant difference was present. In the estimation of the difference in proportions of patients in groups A and B with and without radiotherapy using the bootstrap method, the 95% CI for the d value included the zero value, indicating the possibility of no difference. The mean operating time was 15 min (range 8– 26 min) for group A and 9 min (range 5–15 min) for group B. In estimating the difference using the bootstrap method, the 95% CI for the d value did not include a zero value, so a difference was assumed to be present. The result of Wilcoxon’s rank-sum test was p = 0.023, indicating a significant difference. Figure 2. The tube is checked by palpation at the tracheostoma. Dotted lines represent the course of the endotracheal tube.

A flexible fiberscope was inserted into the endotracheal tube and the end of the tube was confirmed by visually checking the light of the fiberscope via the tracheostoma. For the first seven patients, using the same method reported by Suda et al. [4], exploratory puncture was conducted using a 22G needle with an angle of curvature similar to that of the trocar and the trocar was then inserted (Figure 3). However, the fineness of the exploratory puncture needle made visual confirmation using the fiberscope difficult and caused worsening of the field of view at the time of main puncture due to hemorrhage caused by the exploratory puncture. As a result, for the next 15 patients, puncture was conducted using the trocar without exploratory puncture. After checking the trocar using the flexible fiberscope, we followed the basic method described by Hilgers et al. [1]. This involved attaching the guidewire to the Provox2, inserting transorally and pulling out at the tracheostoma. A 12.5 mm Provox2 was inserted for all patients. The procedure was completed by confirming placement of the Provox2. In statistical analysis, differences were estimated by the bootstrap method and evaluated using Wilcoxon’s rank-sum test.

History of radiotherapy Ten patients had a history of radiotherapy (group C) and 12 did not (group D). Estimating the difference in the age distributions of these two groups using the bootstrap method showed that the 95% CI for the d value included a value of zero, indicating the possibility of no difference. The result of Wilcoxon’s ranksum test was p = 0.372, indicating no significant difference. In estimating differences in the proportions of patients in groups C and D with and without exploratory puncture using the bootstrap method, the 95% CI for the d value included a value of zero, indicating the possibility of no difference. The mean operating time was 13 min (range 7– 20 min) in group C and 9 min (range 5–26 min) in group D. In estimating the difference using the bootstrap method, the 95% CI for the d value did not

Results Results are shown in Table I. Exploratory puncture In an estimation of the difference in age distribution between the 7 patients with exploratory puncture (group A) and the 15 patients without (group B) using the bootstrap method, the 95% confidence interval (CI) for the d value included a zero value,

Figure 3. Exploratory puncture is conducted using a 22G needle with an angle of curvature similar to that of the trocar (upper). The trocar is then inserted (lower).

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include a value of zero, so a difference was assumed to be present. The result of Wilcoxon’s rank-sum test was p = 0.015, indicating a significant difference. Complications

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No complications such as postoperative hemorrhage, shunt leakage or infection were seen in any patient. In case 16, a size mismatch with Provox2 caused difficulty in eating, so the prosthesis was changed to the 6 mm size under general anesthesia on the day following the operation. Discussion Provox2 is one of the most widely used vocal rehabilitation devices. While primary insertion has the advantage of permitting the patient to produce speech immediately postoperatively, serious complications such as cervical cellulitis, mediastinitis, leakage of saliva, retropharyngeal abscess, and carotid hemorrhage have been reported [5,6]. In Japan, secondary insertion is very common. As we sometimes encounter cases following total laryngectomy in which esophageal speech is possible or in which the patient does not desire vocal rehabilitation, we have been practising secondary insertion. Although procedures for insertion under local anesthesia have been reported [7,8], if the overall physical condition is stable, there is less pain for the patient if the procedure is carried out under general anesthesia. As a result, we carry out insertion under general anesthesia in our department. While the basic procedure using a rigid esophagoscope [1] is an excellent method of insertion, cases are sometimes encountered in which secondary insertion is difficult due to scarring of the neck following surgery or radiotherapy. The endotracheal tube, on the other hand, is soft and flexible and available in different sizes, making it easy to use in various types of patients. Until now, among cases in which the endotracheal tube has been used in secondary insertion, the tube has been cut [2,3]. As the procedure described in the paper by Suda et al. [4] (in Japanese) involves no modification of the endotracheal tube and allows easy insertion of the trocar, we have adopted this approach. While we noted a significant difference in operating time in the present cases, we felt it was feasible to apply this procedure in all patients, including those with a history of radiotherapy. However, consideration must be given to three problems. First, the endotracheal tube is easily displaced when the trocar is being inserted. This problem may be solved by holding the neck skin and tube with the left hand and inserting the trocar with the

right. The second problem is with exploratory puncture. As the exploratory puncture needle is very fine, visual confirmation with a fiberscope is difficult. In addition, repeatedly touching the membranous portion of the trachea can cause hemorrhage or tissue edema. Also, repeatedly conducting actions in the area around the shunt is likely to raise the risk of complications such as infection or leakage. For these reasons, we ceased carrying out exploratory puncture and subsequently identified a significant reduction in operating time. As no concomitant increase in complications was observed, we considered our decision to be correct. The third problem is the resistance encountered when inserting the trocar. At 4 mm, the trocar is thick and there is strong resistance on insertion, so the insertion is performed with hesitation until the operator becomes accustomed to it. The secret to success in inserting the trocar in one attempt is being aware of the feeling of the tube in the left hand and making use of the light transmitted from the fiberscope. If a shunt can be formed in a single puncture (no exploratory puncture) using an endotracheal tube, sharp-tipped trocar, flexible fiberscope, and flexible guidewire, postoperative complications are unlikely. We aim to continue study of this approach in the future using a greater number of cases. When Provox2 is inserted using an endotracheal tube and special trocar for this purpose, exploratory puncture is unnecessary, allowing the prosthesis to be inserted through a single puncture with a very low risk of complications. This will be a useful procedure even in patients with a history of radiotherapy. Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. References [1] Hilgers FJ. 2003. Surgical procedure. Primary prosthetic voice rehabilitation. In A practical guide to post-laryngectomy rehabilitation including the Provox system. 4th edn. Amsterdam: The Netherlands Cancer Institute. p 14–18. [2] Maniglia AJ. Vocal rehabilitation after total laryngectomy: a flexible fiberoptic endoscopic technique for tracheoesophageal fistula. Laryngoscope 1982;92:1437–9. [3] Cannon CR. Using an endotracheal tube in difficult secondary tracheoesophageal puncture: a novel technique. Otolaryngol Head Neck Surg 2001;125:117–19. [4] Suda Y, Haruta A, Komatsubara S, Nakazima T, Shimizu J, Naono H, et al. Tracheoesophageal puncture with tracheal tube and flexible endoscope. Nippon Jibiinkouka Gakkai Kaiho 2004;107:1033–7. [5] Andrews JC, Mickel RA, Hanson DG, Monahan GP, Ward PH. Major complications following tracheoesophageal puncture for voice rehabilitation. Laryngoscope 1987;97: 562–7.

Secondary insertion of Provox2 using an endotracheal tube

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[6] Spiro JD, Spiro RH. Retropharyngeal abscess and carotid hemorrhage following tracheoesophageal puncture and voice prosthesis insertion: a case report. Otolaryngol Head Neck Surg 1990;102:162–3. [7] Iwai H, Yukawa H, Miyamoto S, Adachi M, Horiguchi A, Tomoda K, et al. Secondary shunt procedure for laryngeal

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patients in an outpatient clinic. Acta Otolaryngol 2002;122: 661–4. [8] Ng RW, Lam P, Wong BY. Insertion of Provox2 voice prosthesis using the anterograde technique immediately after the secondary tracheoesophageal puncture. J Laryngol Otol 2005;119:988–90.

Secondary insertion of Provox(®)2 using an endotracheal tube.

A procedure with no exploratory puncture using an endotracheal tube, sharp-tipped trocar, flexible fiberscope, and flexible guidewire is useful for in...
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