OBJECTIVE: The aim of the current study was to evaluate the functional outcomes of stapler pharyngeal closure after total laryngectomy by the incidence of PCT and assessment of swallowing after surgery. In addition, the study aimed to evaluate the oncological outcomes in terms of patients\' survival rates.
METHODS: This randomized clinical trial was conducted on 58 patients with advanced laryngeal carcinoma who underwent total laryngectomy. Patients were randomly assigned to two groups according to the method of pharyngeal repair after laryngectomy: manual closure group (n = 28), and stapler group (n = 30). Functional and oncological outcomes were assessed and compared.
RESULTS: The incidence of pharyngocutaneous fistula was significantly less in the stapler group. Additionally, operative time was significantly shorter and swallowing function was better in the stapler group compared to the manual group. There was no statistically significant difference between groups regarding survival rates.
CONCLUSIONS: The stapler is a reliable method for pharyngeal closure after total laryngectomy if the limits of its indications regarding the primary tumor are considered. Stapler closure decreases the incidence of PCF and decreases the surgical time. Good swallowing outcomes are achieved without compromising the oncological outcomes.

OBJECTIVE: The aim of this prospective study was to investigate the role of procalcitonin as an early diagnostic marker of pharyngocutaneous fistula (PCF) in a cohort of head and neck patients treated with total laryngectomy for squamous cell carcinoma.
METHODS: This prospective study was conducted on a sample of patients enrolled from January 2019 to March 2022. All patients were subjected to a \"protocol\" of blood chemistry investigations, scheduled as follows: complete blood count with formula, ESR dosage, CPR, and PCT. PCT was also dosed by salivary sampling and a pharyngo-cutaneous swab in patients who presented with PCF. The dosage scheme was systematically repeated: the day before the intervention (t0); the 5th day postoperative (t1); the 20th day postoperative (t2); and at time X, the day of the eventual appearance of the pharyngocutaneous fistula.
RESULTS: A total of 36 patients met the inclusion criteria. The patients enrolled in the study were subsequently divided into two groups: 27 patients underwent total laryngectomy (TL) for laryngeal cancer without postoperative complications, and 9 patients were undergoing TL with postoperative PCF. Using the Cochran\'s Q test, statistical significance was found for PCT among T0, T1, Tx, and T2 (p-value < 0.001) between the PCF and non-PCF groups. The Z test demonstrated that there is a difference in PCT levels at T1 and T2 and that this difference is statistically significant (p < 0.001).
CONCLUSIONS: PCT could be considered an early marker of complications in open laryngeal surgery. According to our results, it could be useful in the precocious detection of pharyngocutaneous fistulas and in the management of antibiotic therapy.

BACKGROUND: Total laryngectomy (TL) is a surgical procedure commonly performed on patients with advanced laryngeal or hypopharyngeal carcinoma. One of the most common postoperative complications following TL is the development of a pharyngocutaneous fistula (PCF), characterized by a communication between the neopharynx and the skin. PCF can lead to extended hospital stays, delayed oral feeding, and compromised quality of life. The use of a myofascial pectoralis major flap (PMMF) as an onlay technique during pharyngeal closure has shown potential in reducing PCF rates in high risk patients for development of PCF such as patients undergoing TL after chemoradiation and low skeletal muscle mass (SMM). Its impact on various functional outcomes, such as shoulder and neck function, swallowing function, and voice quality, remains less explored. This study aims to investigate the effectiveness of PMMF in reducing PCF rates in patients with low SMM and its potential consequences on patient well-being.
METHODS: This multicenter study adopts a randomized clinical trial (RCT) design and is funded by the Dutch Cancer Society. Eligible patients for TL, aged ≥ 18 years, mentally competent, and proficient in Dutch, will be enrolled. One hundred and twenty eight patients with low SMM will be centrally randomized to receive TL with or without PMMF, while those without low SMM will undergo standard TL. Primary outcome measurement involves assessing PCF rates within 30 days post-TL. Secondary objectives include evaluating quality of life, shoulder and neck function, swallowing function, and voice quality using standardized questionnaires and functional tests. Data will be collected through electronic patient records.
CONCLUSIONS: This study\'s significance lies in its exploration of the potential benefits of using PMMF as an onlay technique during pharyngeal closure to reduce PCF rates in TL patients with low SMM. By assessing various functional outcomes, the study aims to provide a comprehensive understanding of the impact of PMMF deployment. The anticipated results will contribute valuable insights into optimizing surgical techniques to enhance patient outcomes and inform future treatment strategies for TL patients.
BACKGROUND: NL8605, registered on 11-05-2020; International Clinical Trials Registry Platform (ICTRP).

BACKGROUND: We aimed to assess the effectiveness of a single-institution protocol of videofluoroscopic swallowing study (VFSS) for the detection of pharyngeal leak (PL) and its usefulness to mitigate evolution into subsequent pharyngocutaneous fistula (PCF) after total (pharyngo-) laryngectomy (TL).
METHODS: This retrospective single-center study was conducted between February 2014 and December 2022. We included all patients who underwent TL and performed a VFSS between Day 7 and Day 14 postoperatively to detect a subclinical PL.
RESULTS: Two-hundred and forty-eight patients met the inclusion criteria. Among the 186 patients (75%) with a negative VFSS, 11 patients (5.9%) developed a secondary PCF after oral intake resumption (false negative of VFSS). Among the 62 patients (25%) with a positive VFSS, the occurrence of a PCF was avoided in 59.7% of cases.
CONCLUSIONS: This study showed a good effectiveness of VFSS in the detection of PL after TL, alongside a usefulness to mitigate evolution into subsequent PCF.

The determination of cytokines in the postoperative drainage (POD) fluid could be a method for early detection of the development of a pharyngocutaneous fistula (PCF).
We conducted a prospective two-center study involving 28 patients. PODs were collected on Day 1 (D1) and Day 2 (D2) postoperatively for determination of a cytokine panel and cytobacteriological examination.
Eleven (39%) patients presented with PCF on average 13 ± 5.5 days after surgery. Patients with PCF had higher IL-10 (121 vs. 40.3, p = 0.04, effect size (ES) = 0.98 [0.16, 1.79]) and TNFα level (21.2 vs. 2.2, p = 0.02, ES = 0.83 [0.03, 1.63]) on D2. An IL-10 threshold of 72 pg/mL on D2 was diagnostic of the occurrence of PCF with a sensibility of 70%, specificity of 88%.
The determination of cytokines in POD fluid on D2 is a reliable tool for predicting the development of a PCF after total laryngectomy.

Closure of the pharyngeal defect after total laryngectomy had been traditionally performed with manual suturing techniques that invert the mucosal edge this technique though effective, yet it is time-consuming. Recently the use of stapling devices to successfully close the pharyngeal defect after total laryngectomy has been advocated to shorten the operative time, especially in the high-risk cancer patients where a prolonged operative time is not preferred. The present study aimed at comparing stapler assisted total laryngectomy to suture closure total laryngectomy in a prospective randomized manner. This is a prospective clinical study conducted on 60 patients undergoing total laryngectomy at Alexandria Main University Hospital, Egypt. Patients with tumor extension to the hypopharynx or base of the tongue were excluded from the study. The surgical time is reduced with shorter hospital stays and no increase in postoperative complications rate. The use of the stapler is technically easy to perform and as equally as effective as the traditional neopharyngeal suturing techniques in patients undergoing total laryngectomy.

OBJECTIVE: Pharyngocutaneous fistula (PCF) formation following open surgical treatment of hypopharyngeal cancer (HPC) is a common and troublesome complication. To date, the postoperative protocol of restarting oral intake is not clear, and vast discrepancies exist in the literature and among institutions. This study aimed to explore the impact of a postoperative protocol of restarting oral intake on PCF formation after open surgical treatment of primary HPC, and its impact on overall survival (OS) and swallowing function based on the functional outcome swallowing scale (FOSS).
METHODS: This was a prospective observational study of 42 patients who received open surgical treatment for primary HPC at Beijing Friendship Hospital between April 2019 and August 2021. This cohort included two groups: patients who restarted oral intake on the 10th postoperative day (Group 1), and those who started on the 20th (Group 2). The Chi-square test and Fisher\'s exact chi-squared test were used for comparing qualitative data among the groups.
RESULTS: Group 1 (n = 27) and Group 2 (n = 15) were comparable in clinical characteristics. PCF occurred in 7 (25.9%) patients in Group 1, while none occurred in Group 2 (P = 0.038). The 2-year OS of all 42 patients was 75.6%; 65.8% and 93.3% for Groups 1 and 2, respectively (P = 0.07). The swallowing function was satisfactory (FOSS Grades 0-III) for 19 (70.4%) patients in Group 1 and 15 (100%) patients in Group 2 (P = 0.035). Laryngeal preservation was achieved in 25 (59.5%) patients, while decannulation was successful in 22 (88.0%) patients.
CONCLUSIONS: Delayed oral feeding significantly reduces PCF after open surgical treatment of primary HPC, and improves the swallowing function outcome without jeopardizing the OS.

Pharyngocutaneous fistula (PCF) is a major morbidity of salvage total laryngectomy (TL). Understanding the factors predicting PCF is fundamental to managing laryngeal cancer. We aim to assess factors associated with PCF following salvage TL in a multicenter, international retrospective cohort study of academic centers in the US and Canada.
In total, 550 patients post-salvage TL were identified (mean [SD; range] age, 64 [10.4; 32-90] years; 465 [85 %] male and 84 [15 %] female) between 2000 and 2014. Rate of PCF was 23 % (n = 127) with median time to PCF of 2.9 weeks. Surgical management of PCF was required in 43 % (n = 54) while 57 % (n = 73) required wound care alone. Rates of PCF differed by primary treatment modality [radiation, 20 % (n = 76); chemoradiation, 27 % (n = 40); not available (n = 6)] and use of vascularized tissue in pharyngeal closure [free/regional flap, 18 % (n = 25); no vascularized tissue/primary closure, 24 % (n = 98); not available (n = 4)]. There was no statistically significant association between PCF and treatment with chemoradiation (HR, 1.32; 95 % CI, 0.91-1.93, p = 0.14) or lack of vascularized tissue reconstruction (HR, 1.41, 95 % CI 0.91-2.18, p = 0.12). Significant association between PCF and advanced stage (T3 or T4), positive margin, close margin (<5mm), lymphovascular invasion and pre-operative tracheostomy were identified on univariable analysis. Positive surgical margin (HR, 1.91; 95 % CI, 1.11 to 3.29) was the only significant association on multivariable analysis.
We highlight positive surgical margin as the only variable significantly associated with increased risk of PCF following salvage TL on multivariable analysis in a large cohort across several major head and neck oncology centers.

OBJECTIVE: Pharyngocutaneous fistula (PCF) is a devastating complication of laryngectomy. Different factors, principally previous irradiation, increases the risk for PCF formation. The current study objectives is to investigate the potential negative effect of re-irradiation on fistula development. Materilas and methods This is a single, referral, medical center retrospective, cohort study, conducted between the years 2011-2021. Electronic medical files, surgical notes, laboratory records and radiation plan (dose and time interval in case of re-irradiation) were examined. Main outcomes and measures Risk and predictors associated with PCF formation. Risk and severity of PCF in the setting of re-irradiation.
RESULTS: Overall, 27 laryngectomized patients were investigated, of whom 21 patients had single radiation (pre or post-operative radiation) and the other 6 patients had two radiation treatments (before and after laryngectomy). The fistula rate was 33.33% (7/21) in the single radiation compared (p = 0.14) to 66.66% (4/6) in the re-irradiation group of patients (including late-onset fistulas). All single radiation PCF were self-limited, whereas, 3 out of 4 fistulas in the re-irradiation group were longstanding or permanent. In the re-irradiation group of patients, a shorter time interval between the first and second radiation treatments was demonstrated among those with fistula formation compared to patients with uneventful laryngectomy (p = 0.08).
CONCLUSIONS: Re-irradiation and especially a brief interval between the radiation treatments is associated with a severe PCF.

OBJECTIVE: The objective of this study was to evaluate, through multivariate analysis, the configuration of nutritional predictors that impact the development pharyngocutaneous fistula (PCF) after total laryngectomy.
METHODS: A retrospective cohort study carried out on 203 consecutive patients with laryngeal squamous cell carcinoma who underwent total laryngectomy with neck dissection between June 2015 and June 2020. Patients with risk factors for PCF formation, other than malnutrition, were excluded to eliminate the potential impact of that risk factors on PCF formation and to make the study group homogenous. Five parameters were evaluated including preoperative serum prealbumin, albumin and transferrin levels, Body Mass Index (BMI) and Malnutrition Screening Tool (MST).
RESULTS: Univariate analysis revealed that preoperative prealbumin, albumin and transferrin levels significantly correlated with PCF development. Multivariate logistic regression analysis revealed that preoperative prealbumin level was the best independent nutritional predictor of PCF (P value <0.001, odd ratio 11.951 [95% CI 3.686-38.749]) followed by preoperative albumin (P value 0.006, odd ratio 3.985 [95% CI 1.485- 10.694]).
CONCLUSIONS: Preoperative prealbumin level is considered the best independent nutritional predictor of PCF. It should be used to evaluate the nutritional status of patients undergoing total laryngectomy and hence their need for nutritional support.