Discontinuation and nonpublication of pediatric otolaryngology clinical trials.

OBJECTIVES: Randomized controlled trial (RCT) discontinuation and nonpublication are potential mechanisms of waste in resources and lead to decreased advancement of medical science and compromised ethical issues in all specialties. However, the prevalence of discontinued or unpublished RCTs regarding common pediatric otolaryngology disorders and interventions remains unclear. STUDY DESIGN: Cross-sectional analysis. METHODS: Retrospective analysis of common pediatric otolaryngology RCTs registered in ClinicalTrials.gov up until November 2, 2018. Data were collected from the registry, and publication status was identified. If a reason for trial discontinuation or nonpublication was not identified through a systematic search, corresponding trialists were contacted through email. RESULTS: After exclusion, 260 RCTs were included for analysis. Analysis found 198 (76%) RCTs were completed, and 62 (24%) trials were discontinued. The most commonly reported reasons for RCT discontinuation were program termination by sponsor or management (7/24; 29.2%), lack of participant enrollment, difficulty recruiting, or slow accrual (7/24; 29.2%). A total of 192 (192/260; 73.8%) published RCTs and 68 (68/260; 26.2%) unpublished RCTs were identified. Twenty-six (26/62; 42%) of the discontinued RCTs reached publication, while 36 (58%) remained unpublished. Regarding the completed RCTs, 166 of 198 (83.8%) completed trials reached publication, while 32 (32/198; 16.2%) remained unpublished after trial completion. CONCLUSIONS: Approximately 1 in 4 of included RCTs were discontinued or did not reach publication. Findings suggest further guidance is needed for RCTs regarding common pediatric otolaryngology disorders and interventions. LEVEL OF EVIDENCE: NA.

Innovations in Airway Surgery.

The management of pediatric airway stenosis has evolved considerably over time. At the outset, dilation was the mainstay of management. In the 1900s, open surgery in the form of cricoid expansion procedures or resection procedures was the primary treatment with subsequent development of the slide tracheoplasty. Now in the twenty-first century, advances in endoscopic management, balloon dilation, and stenting, along with the advent of external scaffolds and tissue replacement continue to advance pediatric airway surgery.

Oncologic and functional outcomes of pretreatment tracheotomy in advanced laryngeal squamous cell carcinoma: A multi-institutional analysis.

OBJECTIVES: Describe the influence of pretreatment tracheotomy and treatment modality (surgical versus non-surgical) on oncologic and functional outcomes. MATERIALS AND METHODS: Retrospective study of previously untreated advanced-stage laryngeal squamous cell carcinoma patients at two academic tertiary care institutions from 1995 to 2014. RESULTS: Primary outcomes evaluated were disease-free survival, disease-specific survival, and overall survival of pretreatment tracheotomy versus no pretreatment tracheotomy cohorts. Functional status, measured by tracheotomy decannulation and gastrostomy tube placement/removal, was assessed. Of the 226 patients, 31.4% underwent pretreatment tracheotomy. Five-year disease-specific survival was 72.9%, and overall survival was 48.8% for entire cohort. There was a statistically significant decrease in overall survival (p = .03) and disease-free survival (p = .02) for the pretreatment tracheotomy group compared to no pretreatment tracheotomy, which was largely explained by primary tumor stage. Pretreatment tracheotomy was associated with gastrostomy tube placement and was an independent predictor of worse odds of gastrostomy tube removal. Disease stage, distant metastasis, and age independently conferred worse odds of gastrostomy tube removal. CONCLUSION: Patients undergoing pretreatment tracheotomy for primary T4 laryngeal cancer had decreased overall survival compared to patients without pretreatment tracheotomy. There was no difference in local recurrence rates based on tracheotomy status. Organ preservation with chemotherapy and radiation did not result in better functional outcomes than surgery in the pretreatment tracheotomy group as nearly half of patients treated with organ preservation remained tracheotomy dependent. Based on this data, pretreatment tracheotomy may impact oncologic and functional outcomes in advanced disease, and it should be a consideration in an informed decision-making process.

PET-CT and the detection of the asymptomatic recurrence or second primary lesions in the treated head and neck cancer patient.

OBJECTIVES/HYPOTHESIS: The role of follow-up and the detection of recurrent or new primary disease in cancer management remains to be defined. Specifically, the effectiveness and impact on survival of imaging studies that detects disease before it is symptomatic or noted on exam is unknown. STUDY DESIGN: Retrospective chart review. METHODS: A retrospective review was performed on a series of head and neck cancer patients (n = 123), at a single institution from February 18, 2004 to July 9, 2007, who had undergone nonstaging 18F-fluorodeoxyglucose positron emission tomography-computing tomography (FDG PET-CT) scans as an integral part of the patient's follow-up after definitive treatment. Each scan (n = 308) was evaluated by a board-certified nuclear medicine physician, and final scan readings from each patient's medical record were reviewed for this study. RESULTS: Of the 123 patients in the study, 24 (20%) were noted to have asymptomatic lesions (either recurrent or new primaries) indicated on PET/CT (8% of surveillance scans) at an average interval of 35.7 weeks posttreatment. Asymptomatic lesions were detected most frequently at distant sites, with 50% being thoracic, but also included were primary (9%), regional (9%), and other distant (32%) sites. At last follow-up of the 24 patients in whom an asymptomatic lesion was detected, 14 patients have died of disease; 10 patients remain alive, four with disease; and one patient had a subsequent recurrence treated and is currently disease-free. CONCLUSION: PET-CT scanning is an effective tool for detecting asymptomatic disease in patients previously treated for head and neck cancer. Unfortunately, even with early detection of recurrent disease, the mortality rate remains high.