A Practical Approach for the Verification and Determination of Site- and Trimester-Specific Reference Intervals for Thyroid Function Tests in Pregnancy

Thyroid, Ahead of Print.


http://bit.ly/2DSC8JM

Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility

Abstract

Background

Single-sided deafness (SSD) and asymmetric hearing loss (AHL) have recently been proposed as a new indication for cochlear implantation. There is still no recommended treatment for these hearing deficits, and most options considered rely on the transfer of sound from the poor ear to the better ear, using Contralateral Routing of the Signal (CROS) hearing aids or bone conduction (BC) devices. In contrast, cochlear implantation allows the poor ear to be stimulated and binaural hearing abilities to be partially restored. Indeed, most recently published studies have reported an improvement in the spatial localisation of an incoming sound and better speech recognition in noisy environments after cochlear implantation in SSD/AHL subjects. It also provides consistent relief of tinnitus when associated. These encouraging hearing outcomes raise the question of the cost-utility of this expensive treatment in an extended indication.

Methods

The final endpoint of this national multicentre study is to determine the incremental cost-utility ratio (ICUR) of cochlear implantation in comparison to the current standard of care in France through simple observation, using a randomised controlled trial. Firstly, the study comprises a prospective and descriptive part, where 150 SSD/AHL subjects try CROS hearing aids and a BC device for three weeks each. Secondly, the choice is made between CROS hearing aids, BC implanted device and cochlear implantation. Hearing outcomes and quality of life measurements are described after 6 months for the subjects who chose CROS, BC or declined any option. The subjects who opt for cochlear implantation are randomised between one group where the cochlear implant is inserted without delay and one group of simple initial observation. Hearing outcomes and quality of life measurements are compared after 6 months.

Discussion

The present study was designed to assess the efficiency of cochlear implantation in SSD/AHL. A favourable cost-utility ratio in this extended indication would strengthen the promising clinical results and justify a reimbursement by the health insurance. The efficiency of other options (CROS, BC) will also be described.

Trial registration

This research has been registered in ClinicalTrials.gov (http://www.clinicaltrials.gov/), the 29th July 2014 under the n°NCT02204618.

http://bit.ly/2UGSSsW

Cochlear implantation as a treatment for single-sided deafness and asymmetric hearing loss: a randomized controlled evaluation of cost-utility

Single-sided deafness (SSD) and asymmetric hearing loss (AHL) have recently been proposed as a new indication for cochlear implantation. There is still no recommended treatment for these hearing deficits, and ...

http://bit.ly/2UHSWZt

A deep convolutional neural network for the diagnosis of thyroid nodules on ultrasound

Abstract

Background

We designed a deep convolutional neural network (CNN) to diagnose thyroid malignancy on ultrasound (US) and compared the diagnostic performance of CNN with that of experienced radiologists.

Methods

Between May 2012 and February 2015, 589 thyroid nodules in 519 patients were diagnosed as benign or malignant by surgical excision. Experienced radiologists retrospectively reviewed the US of the thyroid nodules in a test set. CNNs were trained and tested using retrospective data of 439 and 150 US images, respectively. Diagnostic performances were compared between the two groups.

Results

Of the 589 thyroid nodules, 396 were malignant and 193 were benign. The area under the curve (AUC) for diagnosing thyroid malignancy was 0.805‐0.860 for radiologists. The AUCs for diagnosing thyroid malignancy for the three CNNs were 0.845, 0.835, and 0.850. There was no significant difference in AUC between radiologists and CNNs.

Conclusions

CNNs showed comparable diagnostic performance compared to experienced radiologists in differentiating thyroid malignancy on US.

http://bit.ly/2BdGWI7

Treatment of oral cancers during pregnancy: a case-based discussion

Malignancies occur in approximately 1:1000 pregnancies; the most common being breast (46%) and hematological (18%) malignancies. Oral cancers account for only 2% of all cancers in pregnant women, and there are...

http://bit.ly/2UGyacY

Pressure induced tissue resection in the larynx: A preliminary canine study

Objectives

The application of laser (light amplification by stimulated emission of radiation) energy in the larynx relies on thermal injury. The impact of this injury on adjacent tissue can be undesirable. Attempts have been made to limit the extent and range of injury to adjacent tissue. The O‐Pel Surgical System (Precise Light Surgical, Inc., Campbell, CA), a new technology, utilizes kinetic energy through Pressure Induced Tissue Resection (PITR) (Precise Light Surgical, Inc.) to cut tissue, theoretically eliminating injury to adjacent tissue. The purpose of this study was to evaluate the PSL in canine vocal folds.

Methods

Four dogs underwent PITR incisions (4 mJ pulses at 200 Hz) on their vocal folds, through mucosa into the muscle. The animals were sacrificed at days 0, 3, 7, and 21 days postsurgery. The larynges were harvested and histology was performed with hematoxylin and eosin, Masson trichrome, and Verhoeff‐van Gieson.

Results

At day 0, focal denudation of the epithelium and coagulation necrosis in the lamina propria and adjacent connective tissue are noted. On days 3 and 7, an inflammatory infiltrate of neutrophils is seen within the lamina propria and surrounding connective tissue with minimal edema and early deposition of collagen. At day 21, the mucosa is completely regenerated with the area of previous PITR into the muscle replaced with thick bundles of collagen.

Conclusion

The unique PITR characteristics offer a potentially unique cutting technology for laryngeal microsurgery. The current canine study suggests appropriate and rapid healing. With refinements of the tip size of the probe and adjustment of energy, PITR will likely be an appropriate alternate to traditional lasers in laryngeal surgery.

Level of Evidence

NA. Laryngoscope, 2019

http://bit.ly/2SsWMZg

Toripalimab or Placebo With Paclitaxel and Cisplatin in Esophageal Squamous Cell Carcinoma

Condition:   Advanced or Metastatic Esophageal Squamous Cell Cancer Without Previous Systemic Chemotherapy
Intervention:   Biological: JS001
Sponsor:   Shanghai Junshi Bioscience Co., Ltd.
Recruiting

http://bit.ly/2I3HMx5

TreatmENT of AnastomotiC Leakage After Esophagectomy

Conditions:   Esophageal Cancer;   Esophageal Neoplasms
Intervention:   Other: Intervantions for anastomotic leakage after esophagectomy
Sponsors:   Radboud University;   Dutch Upper-GI Cancer Audit group (DUCA);   Oesophago-Gastric Anastomosis Audit (OGAA)
Not yet recruiting

http://bit.ly/2t5qNQw

Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer

Condition:   Oropharynx Squamous Cell Carcinoma
Interventions:   Drug: Nivolumab;   Drug: Carboplatin;   Drug: Paclitaxel;   Radiation: Radiation Therapy
Sponsors:   University of Michigan Rogel Cancer Center;   Bristol-Myers Squibb
Not yet recruiting

http://bit.ly/2HPI6iB

TPST-1120 as Monotherapy and in Combination With (Nivolumab, Docetaxel or Cetuximab) in Subjects With Advanced Cancers

Conditions:   Hepatocellular Carcinoma;   Metastatic Castration Resistant Prostate Cancer;   Renal Cell Carcinoma;   Non-small Cell Lung Cancer;   Colorectal Cancer;   Squamous Cell Carcinoma of Head and Neck;   Triple-Negative Breast Cancer;   Urothelial Carcinoma;   Cholangiocarcinoma;   GastroEsophageal Cancer;   Pancreatic Cancer;   Sarcoma
Interventions:   Drug: Part 1 TPST-1120;   Drug: Part 2a TPST-1120 + nivolumab;   Drug: Part 2b TPST-1120 + docetaxel;   Drug: Part 2c TPST-1120 + cetuximab;   Drug: Part 3 TPST-1120;   Drug: Part 4a TPST-1120 + nivolumab;   Drug: Part 4b TPST-1120 + docetaxel;   Drug: Part 4c TPST-1120 + cetuximab
Sponsor:   Tempest Therapeutics
Not yet recruiting

http://bit.ly/2G8dbMR

Safety and Efficacy of KY1044 and Atezolizumab in Advanced Cancer

Conditions:   Squamous Cell Carcinoma of Head and Neck;   Non-small Cell Lung Cancer;   Hepatocellular Carcinoma;   Esophageal Cancer;   Gastric Cancer;   Melanoma;   Renal Cell Carcinoma;   Pancreatic Cancer;   Cervical Cancer;   Triple Negative Breast Cancer;   Advanced Cancer
Interventions:   Drug: KY1044;   Drug: KY1044 and atezolizumab
Sponsor:   Kymab Limited
Recruiting

http://bit.ly/2D7Dm2g

Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.

Condition:   Tonsil Cancer
Intervention:   Radiation: Radiotherapy
Sponsor:   Lund University Hospital
Recruiting

http://bit.ly/2GeoFi7

PD-L1 ImagiNg to prediCt Durvalumab Treatment Response in HNSCC

Condition:   Head and Neck Cancer
Interventions:   Diagnostic Test: PD-L1 imaging;   Drug: Durvalumab
Sponsors:   Radboud University;   AstraZeneca
Not yet recruiting

http://bit.ly/2D9Ywwy

Treatment of oral cancers during pregnancy: a case-based discussion

Abstract

Background

Malignancies occur in approximately 1:1000 pregnancies; the most common being breast (46%) and hematological (18%) malignancies. Oral cancers account for only 2% of all cancers in pregnant women, and there are no standard guidelines for the treatment of oral cancer during pregnancy.

Methods

Between 2007 and 2014, our department managed 1109 patients with oral cancers; four (0.4%) had tongue carcinomas during pregnancy. These cases were retrospectively reviewed.

Results

The four women were aged 29–39 (median 32.5) years. Two underwent partial glossectomy at 39 and 40 weeks' gestation, respectively, one received radiotherapy at 17 weeks' gestation, and one underwent supraomohyoid neck dissection and hemi-glossectomy with a forearm flap reconstruction.

Conclusion

In addition to tumor factors, the wishes of the patient and her family, gestational age, and fetal and maternal conditions are important factors in deciding on a treatment protocol. Moreover, treatment decisions require multidisciplinary approach.

http://bit.ly/2MNDgRY

The protective role of ferulic acid against cisplatin-induced ototoxicity

Publication date: Available online 4 February 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Eu-Ri Jo, Cha Kyung Youn, Yonghyun Jun, Sung Il Cho

Abstract

Objectives

While cisplatin is an effective chemotherapeutic agent, it can cause irreversible hearing loss. Ototoxicity leads to dose reduction during the cisplatin chemotherapy and results in inadequate treatment of malignant tumors. This study aimed to investigate the protective effects of ferulic acid on cisplatin-induced ototoxicity.

Methods

House Ear Institute-Organ of Corti 1 (HEI-OC1) cells were exposed to 30 μM of cisplatin for 24 h with or without pretreatment with ferulic acid. Cell viability was determined using the WST assay. Apoptotic cells were identified using TUNEL assay. Western blot analysis was performed to examine the change in expression of cleaved caspase, cleaved poly-ADP-ribose polymerase (PARP), nuclear factor erythroid 2-related factor 2 (Nrf2), and catalase. Intracellular reactive oxygen species (ROS) were determined by flow cytometry. Real-time PCR analyses were performed to examine the mRNA levels of antioxidant enzymes including glutamate-cysteine ligase catalytic subunit (Gclc), glutathione peroxidase 2 (Gpx2), catalase, and superoxide dismutase 2 (SOD2). Phalloidin staining of the organ of Corti was performed to determine hair cell survival or degeneration.

Results

Pretreatment with ferulic acid before cisplatin exposure significantly increased cell viability, levels of antioxidant enzymes, and hair cell survival. In addition, pretreatment with ferulic acid significantly reduced apoptotic cells, levels of cleaved caspase, levels of cleaved PARP, and intracellular ROS production.

Conclusion

Our results demonstrated that ferulic acid inhibited cisplatin-induced cytotoxicity by preventing ROS formation and inducing the production of endogenous antioxidants and indicated that ferulic acid might be used as a protective agent against cisplatin-induced ototoxicity.

http://bit.ly/2DRpf2B

Patient injuries in pediatric otorhinolaryngology

Publication date: Available online 3 February 2019

Source: International Journal of Pediatric Otorhinolaryngology

Author(s): Johanna Nokso-Koivisto, Karin Blomgren, Leena-Maija Aaltonen, Lasse Lehtonen, Päivi Helmiö

Abstract

Objectives

Patient injuries in children can have lifelong effects on the patient and a marked impact on the whole family. The aim of this study was to identify the errors and incidents leading to patient injuries in pediatric otorhinolaryngology (ORL) by evaluating accepted patient injury claims.

Methods

The records of all accepted patient injury claims in ORL between 2001 and 2011 were searched from the nationwide Patient Insurance Centre registry. Pediatric injuries were reviewed and evaluated in detail, and factors contributing to injury were identified.

Results

In the 10-year study period, 17 (7.6%) of the 223 patient injuries occurred in children, and of these, 15 (88%) were considered operative care. The median age of the patients was 8 years (range 3 to 16 years). All operations were performed as daytime elective surgery and by a fully trained specialist in 93% of the cases. One-half of the cases were routine surgeries for common ORL diseases. The most common incidences were incomplete surgery, retained gauze or foreign body, injury to adjacent anatomic structure, and insufficient charts or instructions (each occurred in 3 cases). The most frequent consequence was burn (n=4). One child died because of post-tonsillectomy hemorrhage.

Conclusions

Patient injuries in pediatric ORL are strongly related to surgery. Most injuries occurred after routine operations by a fully trained specialist. Clinicians should be aware of the most likely scenarios resulting in claims.

http://bit.ly/2MMoWcg