Pharyngocutaneous Fistula Research Articles

Management of Pharyngocutaneous Fistula Post Total Laryngectomy during COVID-19 Pandemic using Type A Botulinum Toxin (Botox A)

Pharyngocutaneous Fistula (PCF) is a well-known and devastating complication post total laryngectomy. With ongoing COVID-19 pandemic resulting in health resource constraints, non-surgical option with Botox A did wonder.

Horizontal pharyngeal closure during total laryngectomy reduces rates of pharyngocutaneous fistula.

Pharyngocutaneous fistula (PCF) is a possible complication following total laryngectomy (TL), with a mean incidence of 17%. We intended to investigate the effect of pharyngeal closure type during TL on the prevention of PCF. We retrospectively reviewed patients that underwent TL with a horizontal pharyngeal closure over a 10-year period. The frequency of PCF clinically, dysphagia, total oral diet, postoperative dilatation of the neopharynx and voice problems were tabulated. Seventy-seven subjects underwent TL due to laryngeal tumor without pharyngeal extension. Of them, 45 underwent a salvage TL. PCF occurred in 1/77 subjects. The rest of the subjects (76/77) did not develop a PCF, neither in the early nor in the late postoperative phase. All subjects (15/77) that underwent implantation of a voice prosthesis were satisfied with their voice. No subject complained about dysphagia. Every subject achieved total oral diet. The horizontal pharyngeal closure is a safe pharyngeal closure technique during TL, reduces PCF rates (< 2%), results in excellent voice rehabilitation and swallowing function, and can also be used during salvage TL instead of a major pectoral flap. This type of closure should be used only in selected patients with laryngeal disease without pharyngeal extension.

Functional Laryngectomy and Quality of Life in Survivors of Head and Neck Cancer With Intractable Aspiration

Late effects of head and neck cancer (HNC) treatment include profound dysphagia, chronic aspiration, and death. Functional laryngectomy (FL) can improve patient survival and quality of life (QoL); however, removing a failing larynx for a noncancer reason is a difficult decision. Data regarding the ability of FL to improve self-perceptions of voice, swallowing, and QOL in survivors of HNC with intractable aspiration are inconclusive. To investigate the association of FL with changes in self-reported perceptions of voice, swallowing, oral intake, QoL, and mood in survivors of HNC experiencing profound dysphagia and intractable aspiration. This cohort study was conducted at a single academic institution and included survivors of HNC with profound swallowing dysfunction and intractable aspiration who underwent FL from July 2016 through March 2022. Of the initial 22 patients enrolled, 2 patients (15%) died of aspiration pneumonia before receiving FL. Data analyses were performed from July 2016 through March 2023. Self-reported measures of voice using the VHI (30-item Voice Handicap Index), swallowing using the EAT-10 (10-item Eating Assessment Tool), functional oral intake scale using the FOIS (Functional Oral Intake Scale), and quality of life using the FACT-H&N (Functional Assessment of Cancer Therapy-Head & Neck) were assessed before FL and at 1, 3, and 6 months after FL. Mood states were evaluated using the POMS (Profile of Mood States, second edition), before FL and at 6 months after FL. The study analyses included 20 patients (mean [SD] age, 72.4 (7.0) years; 19 [95%] males and 1 [5%] female) who underwent FL and had complete data across all time points. Among these, 12 patients (60%) had received chemoradiation for oropharyngeal, 7 (35%) for laryngeal, or 1 (5%) for nasopharyngeal cancer. The mean (SD) time from completion of oncologic treatment to FL was 15.5 (5.5) years. Mean (SD) score on the EAT-10 improved from 33.2 (7.4) to 23.1 (10.8) at 1 month; 12.1 (9.1) at 3 months; and 8.3 (7.4) at 6 months, with a large effect size (η2 = 0.72; 95% CI, 0.54-0.80). Mean (SD) score on the FOIS improved from 2.0 (1.5) to 2.9 (1.7) at 1 month; 4.8 (2.5) at 3 months; and 5.2 (1.7) at 6 months, with a large effect size (η2 = 0.6; 95% CI, 0.38-0.71). Improvement in oral intake was achieved in 19 patients (95%), and feeding tubes were removed in 10 of 16 patients (63%) who were feeding tube-dependent; 6 patients (27%) continued to require supplemental tube feedings. Mean (SD) score on the VHI improved from 63.6 (34.0) to 86.9 (33.7) at 1 month; 71.3 (36.1) at 3 months; and 39.7 (26.9) at 6 months, with a large effect size (η2 = 0.42; 95% CI, 0.19-0.56). Seventeen patients (85%) were able to use a tracheoesophageal voice prosthesis for alaryngeal communication. Mean (SD) score on the FACT-H&N improved from 86.2 (17.8) to 93.6 (18.4) at 1 month; 109.0 (18.4) at 3 months; and 121.0 (16.8) at 6 months, with a large effect size (η2 = 0.64; 95% CI, 0.42-0.74). Mean (SD) score on the POMS improved from 58.9 (13.2) at baseline to 44.5 (9.9) at 6 months, with a large effect size (Cohen d = 1.04; 95% CI, 0.48-1.57). None of the patients experienced major complications of FL; 1 patient (5%) had a postoperative pharyngocutaneous fistula. The findings of this cohort study indicate that FL was associated with marked improvements in self-perception of voice and swallowing, functional oral intake, QoL, and mood state among survivors of HNC. These findings can serve as a framework for FL counseling among HNC survivors experiencing profound dysphagia and intractable aspiration.

Impact of stapler versus manual closure techniques on pharyngocutaneous fistula development post-total laryngectomy: A systematic review and meta-analysis.

Pharyngocutaneous fistula (PCF) is a major complication after total laryngectomy, with significant morbidity and mortality. Whether mechanical stapler closure of the pharynx reduces fistula rates compared to hand-sewn techniques remains unclear. We conducted an updated systematic review and meta-analysis to clarify this question. Five databases were systematically searched from inception through November 2023 for studies comparing stapler versus suture closure for fistula outcomes after laryngectomy. Odds ratios (OR) were pooled using random-effects models and fixed-effects models. Subgroup and sensitivity analyses were performed. Risk of bias was appraised using NHLBI tools. Nine studies with 803 patients were included. Mechanical closure significantly reduced fistula incidence versus suture closure (OR = 0.57, 95% CI 0.34-0.95, p = 0.03). Subgroup analysis found that stapling's protective effect varied by patient age, country/region, linear stapler size and female percentage. Stapling reduced fistula odds by 80% in the Turkey subgroup (OR = 0.20, 95% CI 0.09-0.50) but showed no benefit in other regions. Patients <60 years showed an 84% fistula reduction with stapling (OR = 0.17, 95% CI 0.06-0.45), whereas older subgroups did not. Linear stapler size of 60 mm significantly reduced fistula occurrence while 75 mm did not. There was no evidence that low female percentage mitigated stapling benefits. Mechanical stapler closure after total laryngectomy meaningfully reduces the likelihood of postoperative PCF formation compared to hand-sewn closure, especially for patients younger than 60 years old. The absolute risk reduction supports its utility to prevent this complication.

Latissimus dorsi myocutaneous free flap for the laryngopharyngectomy defect.

Partial or total laryngopharyngectomy defects have traditionally been reconstructed using the radial forearm, anterolateral thigh, or jejunal free flaps. The latissimus dorsi myocutaneous free flap (LDMFF) is an option for high-risk patients with complex laryngopharyngeal ± cutaneous neck defects. Retrospective single-surgeon case series from 2017 to 2022. Outcomes were assessed at both the back donor site and head and neck. Twenty-four patients were identified. Flap survival was 100%. There was 1 (4.2%) pharyngocutaneous fistula and 2 (8.3%) tracheo-esophageal peristomal fistulas. At last follow-up, 17 (71%) were sustaining weight on oral intake, and 7 (29%) were G-tube dependent with 4 of these able to do some type of oral intake. Seven (29.2%) had post-operative stricture/stenosis requiring dilation. There were only minor donor site complications, all managed conservatively. The LDMFF can be a robust reconstructive option, particularly for radiated high-risk patients with complex pharyngeal defects, including skin.

Procalcitonin for Early Detection of Pharyngocutaneous Fistula after Total Laryngectomy: A Pilot Study.

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. 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. 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). 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.

Vitamin D Deficiency in Advanced Laryngeal Cancer and its Association with Pharyngocutaneous Fistula Following Total Laryngectomy.

Nutritional factors in developing some malignancies have been investigated recently. In this study, we evaluated the role of vitamin D in advanced laryngeal cancer and its association with the development of pharyngocutaneous fistula (PCF) following total laryngectomy. A cross-sectional, case-control study was conducted. Fifty-five patients with advanced laryngeal cancer referred for total laryngectomy were included. We also considered 55 healthy individuals after matching age and sex as a control group. Serum levels of 25(OH)D3 were measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. The association of serum 25(OH)D3 with PCF following total laryngectomy was also determined. Vitamin D was significantly lower in patients with advanced laryngeal cancer than in the control group (p < 0.001). Moreover, our results showed that a mean serum concentration of 25(OH)D3 in patients with PCF was significantly lower than in patients without PCF (p < 0.001). Vitamin D deficiency is highly prevalent in advanced laryngeal cancer, most pronounced in those who develop a PFC following total laryngectomy.

Usefulness of Endoluminal Vacuum-Assisted Closure Therapy for Pharyngocutaneous Fistula

Pharyngocutaneous fistula (PCF) is a communication created between the pharynx and skin of the neck associated with flap reconstruction or primary closure of a pharyngeal defect. In patients who underwent laryngectomy and pharyngectomy, salivary accumulation in the deep neck space through the pharyngeal dehiscence can cause life-threatening complications, among which is carotid artery blow-out. Broad-spectrum antibiotics, compressive dressing, and artificial nutrition are usually applied first. Many closing methods have been studied, both surgically (direct repair or using flaps) and non-surgically (negative pressure therapy, hyperbaric oxygen therapy, or botulinum toxin injection). The use of a vacuum-assisted closure system placed endoluminally or externally has been recently reported to treat any leaks in the upper gastrointestinal tract. Here, we report a successfully-treated PCF using the endoluminal vacuum-assisted closure system.

Vascularized Tissue to Reduce Fistula After Salvage Total Laryngectomy: A Network Meta-analysis.

Salvage laryngectomy is more predisposed to complications than primary operations, with pharyngocutaneous fistula (PCF) being among the most challenging to manage. Vascularized flaps are increasingly employed during salvage laryngectomy, with a previous review finding a PCF incidence of 31.2% and 22.2% after primary and flap-assisted closure respectively. We aim to better define the role of vascularized flaps after salvage laryngectomy by performing an updated review comparing the rate of PCF in those undergoing primary or vascularized flap-assisted closure. Pubmed/Medline, CINAHL, and CENTRAL. An updated literature review was conducted of English language literature from 2003 to 2023. A random effects and network meta-analysis of odds ratios (OR) and pooled proportions were conducted. Literature search found 31 studies, including seven from the previous review. Overall random effects pooled PCF rate was 25% (95% CI 0.21; 0.30, I2 = 72%, p = <0.01), whereas incidence in primary closure was 37% (95% CI 0.32; 0.43, I2 = 60%, p = <0.01) and 19% (95% CI 0.12; 0.20, I2 = 47%, p = <0.01) after flap closure. Pooled OR was 0.39 (95% CI 0.28; 0.55, I2 = 36%, p = 0.04) in favor of vascularized tissues. The number needed to treat was 6.5. The rate of PCF was lower after free and pedicled flaps, and on-lay and patch closure compared to primary closure techniques. Network meta-analysis found all combinations of closure techniques and vascularized tissue were superior to primary closure. The updated analysis has demonstrated a widening in the rates of PCF between primary and vascularized flap-assisted closure. Surgeons should strongly consider the use of free or pedicled flaps in any salvage laryngectomy procedure. Laryngoscope, 134:2991-3002, 2024.

Prophylactic pectoralis major flap to compensate for increased risk of pharyngocutaneous fistula in laryngectomy patients with low skeletal muscle mass (PECTORALIS): study protocol for a randomized controlled trial

BackgroundTotal 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.MethodsThis 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.DiscussionThis 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.Trial registrationNL8605, registered on 11-05-2020; International Clinical Trials Registry Platform (ICTRP).

Pharyngeal reconstruction after total laryngectomy with sliding epiglottis: technical aspects with retrospective review.

Several techniques have been employed for defect reconstruction after total laryngectomy, among others sliding epiglottoplasty. As there is a paucity of data on sliding epiglottoplasty after total laryngectomy, this study aimed to present this reconstruction technique in detail with the retrospective analysis of the patients. We retrospectively reviewed single-center medical records of patients who underwent pharyngeal reconstruction after total laryngectomy between 2007-2013, with a follow-up to 2020. The study included patients who had total laryngectomy performed followed by a primary closure or sliding epiglottoplasty. The patients were divided according to the pharyngeal reconstruction technique: sliding epiglottis (n = 38) and primary closure (n = 120). The baseline characteristics of patients, TNM stages, and previous treatment strategies did not differ significantly between the sliding epiglottis and primary closure group. The postoperative complication rates, including the pharyngocutaneous fistulae formation and strictures were comparable between the analyzed groups; however, a slightly higher incidence of pharyngocutaneus fistulae was noted within the patients after sliding epiglottoplasty. Overall 3-year survival of patients who underwent the epiglottoplasty and primary closure group were 73.7% vs. 57.5%, respectively. Sliding epiglottoplasty is considered a safe reconstruction technique. Although slightly better outcomes were noted within the epiglottoplasty group, it is still considered inferior to the primary closure. This technique ought to be considered in meticulously selected patients in whom primary closure is not feasible, epiglottis with nearby structures is spared from disease, and when the distal flaps are less appropriate or contraindicated.

The use of Montgomery salivary bypass tubes and pharyngocutaneous fistula following salvage laryngectomy.

Pharyngocutaneous fistula (PCF) is the most common complication to follow total laryngectomy (TL) and is associated with increases in length of hospital stay and with a need for revision surgery or readmission, as well as with delays in return to oral diet. Patients who require salvage TL (STL) or primary (chemo)radiation therapy are at higher risk for developing PCF. Due to the quality-of-life burden of PCF on patients, limiting this occurrence is crucial. We conducted a retrospective cohort study of patients undergoing STL with placement of Montgomery salivary bypass tube (MSBT)™ for at least 2 weeks duration between 2013 and 2017 at a single institution. Our patients all underwent free flap reconstruction. Our primary outcome of interest was development of PCF. Secondary outcomes included demographics, previous treatment, base of tongue (BOT) involvement, extent of defect, concurrent neck dissection (ND), and margin status. Univariate χ 2 analysis was used to evaluate factors associated with PCF. Forty-four patients underwent STL with Montgomery tube placement and free flap reconstruction. Eight developed PCF (18.2%). The average age was 61.6 years; 36 patients were male (81.8%), whereas eight patients were female (18.2%). There was no association between PCF and previous chemoradiation versus radiation (15.8% vs. 33.3%, P < 0.30), BOT involvement versus not (11.1 vs. 22.2%, P < 0.38), circumferential versus partial defect (18.8% vs. 17.9%, P < 0.94), ND versus none (10% vs. 25%, P < 0.20), or margin status. PCF complicated 18.2% of STL cases at our institution and was not associated with differences in primary treatment modality, presence of concomitant ND, extent of pharyngeal defect, BOT involvement, or positive frozen or permanent surgical margin.

Videofluoroscopic swallowing study to detect pharyngeal leak after total (pharyngo-) laryngectomy: Retrospective assessment of a single-institution protocol.

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). 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. 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. This study showed a good effectiveness of VFSS in the detection of PL after TL, alongside a usefulness to mitigate evolution into subsequent PCF.

Institutional experience with total pharyngectomy reconstruction: Exploring the role of the salivary bypass tube.

There is a lack of consensus regarding the effectiveness of salivary bypass tubes during total pharyngectomy reconstruction to prevent pharyngocutaneous fistula or pharyngoesophageal stricture. Our study examined tubed free flap reconstruction outcomes for total pharyngectomy defects over 11 years at a single tertiary referral center. We compared postoperative fistula and stricture rates between two groups: those with salivary bypass tubes inserted during reconstruction and those without. Among 36 patients, 26 had radial forearm, and 10 had anterolateral thigh free flap reconstruction. 53% received salivary bypass tubes. However, the tubes did not significantly reduce the relative risks of fistula or stricture. Notably, neck dissection during total pharyngectomy was associated with increased fistula incidence. Minor salivary bypass tube-related complications affected 21% of subjects. The role of salivary bypass tubes in total pharyngectomy reconstruction remains uncertain.

Our experience in postoperative management of totallaryngectomy – A case series

Total Laryngectomy (TL) is recommended as a treatment for advanced laryngeal cancers, while salvage totallaryngectomy is performed as a secondary procedure after recurrence following laser surgery, radiation, orchemoradiation. Establishing comprehensive standards of care for patients undergoing total laryngectomy in thepostoperative period has proved challenging. Perioperative care continues to exhibit considerable variability, oftenrelying on anecdotal practices. The objective of this study was to disseminate our knowledge and expertise ona case series of patients who have undergone TL and the challenges we encountered during the postoperativeperiod and to identify postoperative complications risk factors and their management in the perioperative careof total laryngectomy patients. A retrospective analysis of 10 patients who underwent total laryngectomy at RajivGandhi Government General Hospital, Chennai, was included in the study. Four of them were cases of recurrentlaryngeal carcinoma following the initial failure of definitive radiation (RT), either with or without chemotherapy. 4out of 10 patients developed complications. Complications, primarily pharyngocutaneous fistulas were observedin 3 patients, which were managed surgically by flap cover closure. Complications occurred among patientswith risk factors for inadequate wound healing, such as comorbidities like diabetes mellitus and radiation, whichincreased hospital stay, antibiotic duration, and time to initiate oral feeds among reconstructed patients. Thisanalysis contributes insights into postoperative challenges and risk factors associated with complications in TLpatients.

Reconstruction using a free jejunal patch flap in salvage head and neck surgery after radiotherapy

Background Chemoradiotherapy is a standard treatment for functional preservation in patients with advanced head and neck carcinoma. However, chemoradiotherapy increases the risk of postoperative complications. Aims/objectives We report the usefulness of reconstruction using a free jejunal patch flap in treating recurrence or residual head and neck carcinoma after radiotherapy. Furthermore, we investigated the factors for the occurrence of postoperative complications in patients who underwent salvage surgery using a free flap transfer. Material and methods This study included 41 patients with head and neck carcinoma who underwent salvage surgery using a free flap transfer, including 11 patients who underwent reconstruction using a free jejunal patch flap. Prognostic analysis was performed for the development of complications. Results Ten jejunal patch flaps survived without microvascular problems. One patient underwent revision reconstructive surgery because of flap failure. However, no patient had a pharyngocutaneous fistula. Oral intake could be resumed in all patients at a median 14 days postoperatively. Multivariate logistic regression analysis indicated that the use of cutaneous flaps was significantly associated with the development of complications. Conclusions and significance Free jejunal patch flaps can be considered useful for head and neck reconstruction after radiotherapy for early intake resumption and complication prevention.

Hybrid primary puncture in stapler-assisted total laryngectomy.

In Video S1, a new surgical technique for hybrid primary tracheoesophageal (TE) puncture in stapler-assisted total laryngectomy is shown. The video describes the surgical steps of the procedure and illustrates some tips and tricks. The procedure incorporates an upper mini-pharyngotomy to enable retrograde placement of the voice prosthesis (VP), eliminating the need for rigid esophagoscopy. This has made it possible to exploit, without additional risks, the potential of the stapler combined with primary TE puncture and VP placement. In our experience, this hybrid procedure in stapler-assisted total laryngectomy is not related to adverse events such as pharyngocutaneous fistula (PCF), hypertonicity, and functional complications. Therefore, it can be considered a valid technique that allows for easy insertion of a primary voice prosthesis also in case of mechanical sutures.

A Novel and Simple Technique to Reduce the Rate of Pharyngocutaneous Fistula Formation Following a Total Laryngectomy - our Initial Results.

The online version contains supplementary material available at 10.1007/s12070-023-04343-7.

Predictors of multiple dilations and functional outcomes after total laryngectomy and laryngopharyngectomy.

Following total laryngectomy (TL) or laryngopharyngectomy (TLP), patients may develop strictures that require multiple dilations to treat. However, the risk factors associated with dysphagia refractory to a single dilation are unknown. Single-institution retrospective review of patients who underwent at least one stricture dilation after TL/TLP between March 2013 and March 2022. A total of 49 patients underwent stricture dilation after TL/TLP. Thirty-five (71%) underwent multiple dilations. Pharyngocutaneous fistula, primary chemoradiation therapy, and a shorter time interval from TL/TLP to first dilation were independently associated with dysphagia requiring multiple dilations. Patients in the multiple dilations group had a higher rate of limited diet and G-tube dependence compared to patients in the single dilation group. Shorter time interval to stricture formation is a prognostic indicator of the need for multiple dilations following TL/TLP. Patients requiring multiple dilations are at increased risk of persistent dysphagia long-term.

Early detection of pharyngocutaneous fistulae after total laryngectomy by cytokine in drainage: A pilot study (DEFILAC).

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.