The European Larynx Organ Preservation Study [MK-3475-C44].

The European Larynx Organ Preservation Study (ELOS; NCT06137378) is a prospective, randomized, open-label, two-armed parallel group controlled, phase II multicenter larynx organ preservation (LOP) trial in locoregionally advanced (LA) stage III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx (LHSCC) amenable for total laryngectomy (TL) with PD-L1 expression within tumor tissue biopsy, calculated as CPS ≥ 1. Induction chemotherapy (IC) with docetaxel and cisplatin (TP) followed by radiation will be compared to TP plus PD-1 inhibition by pembrolizumab (MK-3475; 200 mg i.v. starting day 1 q3w for 17 cycles). After a short induction early response evaluation (ERE) 21 ± 3 days after the first cycle of IC (IC-1), responders achieving endoscopic estimated tumor surface shrinkage (ETSS) ≥30% will get an additional two cycles of IC followed by intensity-modulated radiotherapy 70-72 Gy (EQD2/α/ß = 10) aiming at LOP. Nonresponders (ETSS < 30% or progressing disease) will receive TL and bilateral neck dissection followed by postoperative radiation or chemoradiation as recommended by the clinic's multidisciplinary tumor board. Pembrolizumab treatment will be continued in the intervention arm regardless of ETSS status after IC-1 in both responders and laryngectomized nonresponders, independent of subsequent decisions on adjuvant therapy after TL. Clinical Trial Registration: clinicaltrials.gov, identifier NCT06137378.

A NSQIP study comparing surgical outcomes between primary and non-primary TEPs after total laryngectomy.

OBJECTIVE: Tracheoesophageal puncture with voice prosthesis (TEP) is considered the gold standard for voice rehabilitation after total laryngectomy; however, there is debate as to whether it should be inserted concurrently with removal of the larynx (primary TEP), or as a separate, additional procedure at a later date (secondary TEP). We utilized the National Surgical Quality Improvement Program Database (NSQIP) to compare postoperative complications, readmission rates, and reoperation rates among individuals who underwent total laryngectomy with or without concurrent TEP placement. METHODS: We conducted a retrospective study using the American College of Surgeons National Surgical Quality Improvement Program database (ACS-NSQIP) from 2012 to 2019. Patients were categorized into primary and non-primary TEP groups using a variation of CPT codes for total laryngectomy, tracheoesophageal prosthesis, and type of reconstruction. Univariate analyses were performed and significance was determined at p < 0.05. RESULTS: A total of 1974 patients who underwent total laryngectomy were identified from the database: 1505 (77.3 %) in the non-primary TEP group and 442 (22.7 %) in the primary TEP group. Patients in the non-primary TEP group were more likely to have an ASA class greater than or equal to three (91.2 % primary vs. 84.6 % non-primary, p < 0.001). Patients in the non-primary TEP group were also more likely to require intraoperative or postoperative blood transfusions within the first 72 h of surgery (20.5 % non-primary vs. 15.3 % primary, p = 0.016). Both groups had similar rates of wound breakdown and dehiscence. There remained no significant difference based on type of reconstruction. CONCLUSIONS: This study suggests that patients receiving primary TEPs are not at a greater risk of developing wound complications such as pharyngocutaneous fistulas in the 30-day postoperative period. This remained true when patients were stratified by type of flap reconstruction. Patients in the non-primary TEP group were more likely to have an ASA category of 3 or greater, which may explain why they experienced higher rates of complications such as blood transfusions intra-operatively or post-operatively.

Novel application of a thyroid gland flap in repairing a mucosal defect to prevent pharyngocutaneous fistula following total laryngectomy: a case report.

Background: Resection of pharyngeal or laryngeal tumors often results in mucosal defects. Which may lead to excessive suture line tension and pharyngocutaneous fistula. The incidence of pharyngocutaneous fistula formation after total laryngectomy is relatively common. In order to reduce the tension of the suture line, a variety of flaps were introduced to repair the defect. Every flap has some defects. For example, the free skin flap may require microvascular anastomosis technology and relatively increase the operation time. The pectoralis major or latissimus dorsi skin flap needs to increase the incision outside the neck region. Therefore, it is very important to design the optimal personalized repair method for specific patients. In this case, in order to minimize the trauma and quickly complete defect repairing, we introduced an innovative application of a pedicled regional flap. To the best of our knowledge, the application of thyroid gland flap (TGF) in this case has not been reported. Meanwhile, it also provides a new option for cervical defect repairing. Case Description: In this case report, a 78-year-old male patient complained of "hoarseness for 3 months and dyspnea for 1 week", and was confirmed as having laryngeal squamous cell carcinoma. He underwent total laryngectomy under general anesthesia. After total laryngectomy, the pharyngeal mucosal defect observed was about 2.0 cm × 2.0 cm. Due to the patient's advanced age and relative weakness, a TGF application from the same incision was used to prevent pharyngocutaneous fistula formation following total laryngectomy. The treatment was successful without any associated complications. Conclusions: In conclusion, a TGF application can be used to repair defects in the neck in selectively suitable cases. The TGF preserving the superior pole vessel can be safely used in mucosal decompression after total laryngectomy.

The Pharyngoesophageal Segment After Total Laryngectomy.

OBJECTIVE: The aim of the present study was to characterize the pharyngoesophageal segment in laryngectomees who rated themselves as functional tracheoesophageal speakers. METHODS: Voice perceptual assessment, high-resolution videomanometry of swallowing and phonation, and high-speed camera recording during phonation provided information about the anatomy and function of the pharyngoesophageal segment. RESULTS: Fourteen patients were included in the study. The voice assessments presented high intra/inter-listener reliability. We found a significant correlation between roughness and poor voice quality, hyperfunction and poor intelligibility, and poor voice quality, long time since the operation, and old age. High-resolution videomanometry during phonation revealed decreasing mean pressures from the distal esophagus to the pharynx and confirmed low resting pressures at the pharyngoesophageal segment and low esophageal peristaltic contraction pressures after laryngectomy in comparison to normal subjects. The neoglottis shape was mainly circular and presented a strong mucosal wave in most of the patients on the high-speed camera recording. CONCLUSIONS: Perceptual voice assessment and high-speed camera recordings provided baseline information about voice characteristics and vibration regularity of the neoglottis. Additionally, the quantitative measures obtained with high-resolution videomanometry may have clinical applicability as reference data in voice rehabilitation after total laryngectomy.