The optimal treatment for gastroesophageal junction adenocarcinoma (GEJA) remains controversial. We evaluated the treatment patterns and outcomes of patients with locally advanced GEJA according to the histological type.
Objective Our objective is to evaluate the safety in patients with cochlear implants (CIs) and auditory brainstem implants (ABI) undergoing 1.5 Tesla (T) magnetic resonance imaging (MRI). Secondly, we want to raise awareness on CI and MRI safety, and advocate for continued improvement and advancement to minimize morbidity for our CI patients. Methods Retrospective case series from 2006 to 2018 at a single tertiary academic center. Data was collected on patients with CI or auditory brainstem implants undergoing MRI. Outcomes collected include demographic data, age at time of MRI, MRI characteristics, complications, CI manufacturer, and image quality. Results Eighteen patients with CI or ABI collectively underwent a total of 62 MRI scans. Five of 15 (33%) CI patients with magnet had complications: five total of 24 MRI scans (21%). Two patients had magnet removal prior to 29 MRI scans without complications. Four of five MRI‐related complications were equipped with a U.S. Food and Drug Administration‐approved head wrap. Three of five required a trip to the operating room to explore and reposition the CI magnet; two could not complete MRI secondary to pain. Of the complications, two were Cochlear (Sydney, Australia), two Advanced Bionics (Valencia, CA), and one MED‐EL (Innsbruck, Austria). Synchrony model (MED‐EL) had 0 of seven complications, with a total of 19 MRI scans, which features a freely rotating and self‐aligning magnet. Conclusion Our series offers a diverse number of CI manufacturers and is in accordance with other literature that CI MRI‐related adverse events are occurring at an unacceptable frequency. We can promote CI MRI safety through our institutions' MRI CI patient protocols, raise awareness that diagnostic MRI benefits must outweigh CI‐related complications, and advocate for continued industry technological innovation. Level of Evidence 4 Laryngoscope , 129:482–489, 2019
The aim of our study was to assess feasibility of using a 1.3mm semi-rigid interventional salivary endoscope for middle ear endoscopy and as a route for trans-tympanic delivery of medication in human cadaveric temporal bones.Five temporal bones harvested from human cadavers were examined. A 1.3mm diameter 0 degree. Marchal interventional sialendoscope equipped with an interventional channel (0.4 mm) and an irrigation/suction channel was used. Middle ear endoscopy was performed via endoscopic guided postero-inferior and antero-superior myringotomies. The round window niche (RWN) was easily identified, and a guide wire was placed within the RWN. Also, the Eustachian tube orifice was identified and cannulated with a guide wire.Access to the RWN was obtained via a postero-inferior myringotomy in all five temporal bones (100%). A guide wire could be navigated to the RWN without difficulty in all patients. The opening to the ET was visualized and could be cannulated with a guide wire in all patients where it was attempted (N=3).The 1.3 mm interventional sialendoscope allowed adequate visualization of the ET, middle ear space, and the RWN with interventional capabilities in a cadaveric model. Our result validates the feasibility of its use for trans-tympanic drug delivery. However, the proposed indication for the use of the sialendoscope needs to be evaluated in a clinical setting. Additional cadaveric and human studies are necessary to further investigate additional applications for its use in the field of otolaryngology.
Abstract Objective: This study aimed to assess the feasibility of using a 1.3 mm, semi-rigid, interventional salivary endoscope for middle-ear endoscopy, and as a trans-tympanic route for delivery of medication, in human cadaveric temporal bones. Study design: Human cadaveric study. Methods: Five temporal bones harvested from human cadavers were examined. A 1.3 mm, interventional sialendoscope was used to make endoscopy-assisted myringotomy incisions in the postero-inferior quadrant ( n = 5) and the antero-inferior quadrant ( n = 3). Results: Middle-ear examination was successful in all specimens ( n = 5). Access to the round window niche and adequate visualisation of the round window were achieved in all five temporal bones (100 per cent). A guide wire could be navigated to the round window niche without difficulty. Other structures identified in all specimens included the incudostapedial joint, stapedius tendon, pyramidal eminence and facial nerve via an extended myringotomy incision. The anterior middle-ear space was also successfully examined through an endoscope-guided anterior myringotomy. The opening to the eustachian tube was visualised and cannulated with a guide wire in all preparations in which this was attempted ( n = 3). Conclusions: The 1.3 mm, interventional sialendoscope allowed adequate visualisation of the eustachian tube, middle-ear space and round window niche, with interventional capabilities, in a cadaveric model. Our result validates the feasibility of its use for trans-tympanic drug delivery.
Nanoparticles are currently being investigated in a number of human clinical trials. As information on how nanoparticles function in humans is difficult to obtain, animal studies that can be correlative to human behavior are needed to provide guidance for human clinical trials. Here, we report correlative studies on animals and humans for CRLX101, a 20- to 30-nm-diameter, multifunctional, polymeric nanoparticle containing camptothecin (CPT). CRLX101 is currently in phase 2 clinical trials, and human data from several of the clinical investigations are compared with results from multispecies animal studies. The pharmacokinetics of polymer-conjugated CPT (indicative of the CRLX101 nanoparticles) in mice, rats, dogs, and humans reveal that the area under the curve scales linearly with milligrams of CPT per square meter for all species. Plasma concentrations of unconjugated CPT released from CRLX101 in animals and humans are consistent with each other after accounting for differences in serum albumin binding of CPT. Urinary excretion of polymer-conjugated CPT occurs primarily within the initial 24 h after dosing in animals and humans. The urinary excretion dynamics of polymer-conjugated and unconjugated CPT appear similar between animals and humans. CRLX101 accumulates into solid tumors and releases CPT over a period of several days to give inhibition of its target in animal xenograft models of cancer and in the tumors of humans. Taken in total, the evidence provided from animal models on the CRLX101 mechanism of action suggests that the behavior of CRLX101 in animals is translatable to humans.
Acute gastrointestinal (GI) graft-vs-host disease (aGVHD) is the most complication of hematopoietic stem cell transplant (HSCT) in patients with hematologic malignancy. Limited data exists on endoscopic evaluation of GVHD in post-HSCT patients with differing GI symptoms. Further, the diagnostic value of gross endoscopic findings as well as the safety of endoscopy in this commonly thrombocytopenic and neutropenic patient population remains unclear.To understand the diagnostic value of symptoms and gross endoscopic findings as well as safety of endoscopy in aGVHD patients.We analyzed 195 endoscopies performed at City of Hope in patients who underwent allogeneic HSCT less than 100 d prior for hematologic malignancy and were subsequently evaluated for aGVHD via endoscopy. The yield, sensitivity, and specificity of diagnosing aGVHD were calculated for upper and lower endoscopy, various GI tract locations, and presenting symptoms.Combined esophagogastroduodenoscopy (EGD) and flexible sigmoidoscopy (FS) demonstrated a greater diagnostic yield for aGVHD (83.1%) compared to EGD (66.7%) or FS (77.2%) alone with any presenting symptom. The upper and lower GI tract demonstrated similar yields regardless of whether patients presented with diarrhea (95.7% vs 99.1%) or nausea/vomiting (97.5% vs 96.8%). Normal-appearing mucosa was generally as specific (91.3%) as abnormal mucosa (58.7%-97.8%) for the presence of aGVHD. Adverse events such as bleeding (1.0%), infection (1.0%), and perforation (0.5%) only occurred in a small proportion of patients, with no significant differences in those with underlying thrombocytopenia (P = 1.000) and neutropenia (P = 0.425).Combined EGD and FS with biopsies of normal and inflamed mucosa demonstrated the greatest diagnostic yield regardless of presenting symptom and appears to be safe in this population of patients.
