Steroid initiation timing and outcome of coronavirus disease 2019 patients: A multicenter, retrospective, observational study.

Objectives: Dexamethasone's (DEXA) beneficial effect on survival when administered to critically ill patients with coronavirus disease 2019 (COVID-19) has been documented in randomized trials and meta-analyses. Here, we conducted this study to clarify the association between time from COVID-19 onset to steroid initiation and mortality and to examine the factors underlying these results.Methods: This was a multicenter, retrospective, observational study of patients enrolled in the Japanese COVID-19 Registry from January 1, 2020, to April 30, 2021. Demographic and clinical factors were extracted from patient records. Patients diagnosed with COVID-19 using polymerase chain reaction, loop-mediated isothermal amplification, or antigen tests were included. Patients aged <18 years, pregnant, with a history of chronic obstructive pulmonary disease or steroid or immunosuppressive drug use, transferred to another hospital, or with an unknown symptom onset were excluded.Results and Conclusion: The analysis included 3692 patients (men, 64.1%; median age, 68 years). Unadjusted comparisons of mortality groups showed significant differences in demographic and clinical characteristics; patients with early dexamethasone initiation had more risk factors for severe disease and significantly higher mortality than did patients with delayed initiation (13.3% vs 7.9%, p < .001). No significant differences were found in intubation rates or duration, length of hospitalization, or time from intubation to death. Multivariate analyses showed significant differences from symptom onset to steroid administration, with an adjusted odds ratio of 0.7 (p = .05) for patients who received steroids for ≥8 days. Early steroid administration to COVID-19 patients was associated with increased mortality, suggesting a subset with early severe disease and high mortality and/or adverse effects of early steroid administration.

Dengue Fever Complicated with Hemophagocytic Lymphohistiocytosis: A Case Report of Resolution with Steroid-Sparing Supportive Care.

Dengue fever (DF) can be complicated by hemophagocytic lymphohistiocytosis (HLH). Steroid administration is markedly effective for this hematologic complication, and for other viral infections. We present a rare case of DF-associated HLH that improved with steroid-sparing supportive care. A 47-year-old Japanese male with diabetes mellitus and no history of DF traveled to the Philippines 10 days before his hospitalization. Three days before emergency admission, he experienced fever and joint pain and was referred to our hospital for suspected DF, after blood tests indicated liver damage and thrombocytopenia. Erythema of the extremities and trunk appeared on day 2, and the next day neutrophils were 550 cells/µL, platelets 29,000 cells/µL, ferritin 9840 ng/mL, and fibrinogen 141 mg/dL. Bone marrow aspirate revealed hemophagocytic lymphohistiocytosis, and he was diagnosed with HLH. On day 4, the symptoms and findings improved; only supportive care without steroids was continued. He tested positive for dengue virus antigen on admission. He was discharged on day 9 of hospitalization in good general condition with no vascular leakage or bleeding and recovery of blood cells. Although steroid administration is markedly effective in cases of DF complicated by HLH, this case suggests that such cases can resolve with steroid-sparing supportive care.

Hyponatremia due to adrenal insufficiency after a Mamushi bite: a case report.

BACKGROUND: Mamushi bites are the most common venomous snake bites in Japan, with known complications including rhabdomyolysis and acute kidney injury; however, adrenal insufficiency as a result of snake bites has not been previously reported. We report a case of empty sella with transient adrenal insufficiency during hospitalization for a Mamushi bite. CASE PRESENTATION: An 84-year-old man was admitted to our hospital with a Mamushi bite on the right fifth finger. Serum sodium (Na) level remained in the normal range. On the ninth day of admission, he developed hyponatremia, with a serum Na level of 114 mEq/L and serum cortisol level of 4.0 µg/dL (reference value 4.5-21.1 µg/dL). His serum Na level was restored within the normal range after administration of corticosteroids with 3% NaCl solution. Both rapid adrenocorticotrophin and corticotropin-releasing hormone loading tests showed low cortisol response. Based on the results of the hormone loading tests, a diagnosis of pituitary adrenal insufficiency was made. Contrast-enhanced pituitary magnetic resonance imaging (MRI) showed primary empty sella. After discontinuation of corticosteroids, the hyponatremia did not recur, and the patient was discharged on the 24th day of hospitalization. After discharge, the patient visited an outpatient clinic, but hyponatremia recurrence was not observed. CONCLUSIONS: This is the first report of hyponatremia due to pituitary adrenal insufficiency during hospitalization for a Mamushi bite in a patient with empty sella. When hyponatremia occurs during hospitalization for a Mamushi bite, cortisol measurement, hormone loading test, and head MRI should be performed to search for pituitary lesions because of the possibility of adrenal insufficiency caused by snake venom.

Assessment of predictive factors associated with the technical difficulty of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma: Japanese multicenter retrospective study.

OBJECTIVES: Endoscopic submucosal dissection (ESD) for superficial esophageal squamous cell carcinoma (ESCC) is performed for the treatment of lesions with varied backgrounds and factors. However, the predictive factors associated with the technical difficulty of ESD remain unknown in patients with varied lesions. Therefore, this study aimed to identify the predictive factors associated with the technical difficulty of ESD for ESCC using a retrospective cohort. METHODS: This multicenter, retrospective study was conducted in 10 hospitals in Japan. Consecutive patients who underwent esophageal ESD between January 2013 and December 2019 were enrolled. Lesions of subepithelial tumors, adenocarcinoma, and adenoma were excluded. Difficult lesions were defined as ESD requiring a long procedure time (≥120 min), perforation development, piecemeal resection, or discontinued ESD. In the present study, the clinical factors were assessed to identify the technical difficulty of ESD using univariate and multivariate analyses. RESULTS: Among 1708 lesions treated with esophageal ESD, eight subepithelial tumors, 44 adenocarcinomas, and two adenomas were excluded. Finally, 1505 patients with 1654 lesions were analyzed, and 217 patients with 217 lesions (13.1%) were classified as patients with difficult lesions. In multivariate analysis, the predictive factors associated with the technical difficulty of ESD were as follows: tumors with varices, tumors with diverticulum, antiplatelet use (discontinued), circumference of tumor (≥1/2), preoperative tumor size ≥30 mm, trainee, and nonhigh-volume center. CONCLUSION: This multicenter retrospective study identified the predictive factors associated with the technical difficulty of ESD for ESCC with varied backgrounds and factors.

Long-Term Outcomes of Endoscopic Submucosal Dissection for Early Remnant Gastric Cancer: A Retrospective Multicenter Study.

INTRODUCTION: Favorable long-term outcomes of endoscopic submucosal dissection (ESD) for early remnant gastric cancer (ERGC) have been reported in single-center studies from advanced institutions. However, no studies have examined the long-term outcomes using a multicenter database. This study aimed to investigate the long-term outcomes of the aforementioned approach using a large multicenter database. METHODS: This retrospective multicenter cohort study included 242 cases with 256 lesions that underwent ESD for ERGC between April 2009 and March 2019 across 12 centers. We investigated the long-term outcomes of these patients with the Kaplan-Meier method, and the relationship between curability, additional treatment, or hospital category, and the survival time was evaluated using the log-rank test. RESULTS: During the median follow-up period of 48.4 months, the 5-year overall survival rate was 81.3%, and the 5-year gastric cancer-specific survival rate was 98.1%. The survival time of patients of endoscopic curability (eCura) C-2 without additional surgery was significantly shorter than the corresponding of patients of eCura A/B/C-1 and eCura C-2 with additional surgery. There was no significant difference in either overall survival or gastric cancer-specific survival rate between the high-volume and non-high-volume hospitals. CONCLUSION: The gastric cancer-specific survival of ESD for ERGC using a multicenter database was favorable. ESD for ERGC is widely applicable regardless of the hospital case volume. Management in accordance with the latest guidelines will lead to long-term survival.

Association between Adverse Reactions to the First and Second Doses of COVID-19 Vaccine.

This study investigated the frequency of adverse reactions to COVID-19 vaccines in Japan and the impact of first-dose adverse reactions on second-dose adverse reactions. Individuals who received an mRNA COVID-19 vaccine at our center in March or April 2021 were included. Data were collected using questionnaires. The main factors were age (<40, 40−59, and >60 years), sex, underlying disease, and first-dose adverse reaction. The primary outcomes were incidence of local and systemic adverse reactions (ARs) attributable to the vaccine. Logistic regression was used to calculate odds ratios (ORs) and 95% confidence intervals (CIs). Among 671 participants, 90% experienced local or systemic ARs. An AR to the first dose was associated with a significantly increased risk of an AR to the second dose (OR: 49.63, 95% CI: 21.96−112.16). ARs were less common among men than among women (OR: 0.36, 95% CI: 0.17−0.76). Local ARs were less common among those aged 60 years or older (OR: 0.35, 95% CI: 0.18−0.66), whereas systemic ARs were more common among those aged under 40 years. Information on ARs to the first dose is important for healthcare providers and recipients when making vaccination decisions.

A Ruptured Left Gastric Artery Aneurysm That Neoplasticized during the Course of Coronavirus Disease 2019: A Case Report.

Coronavirus disease 2019 (COVID-19) is an acute respiratory syndrome caused by SARS-CoV-2 and is known to cause respiratory and systemic symptoms. A SARS-CoV-2 infection is involved in aneurysm formation, enlargement, and rupture in medium-sized vessels, such as the cerebral and coronary arteries and the aorta. In contrast, its involvement in forming aneurysms in medium-sized vessels other than the cerebral and coronary arteries has not been reported. An 84-year-old Japanese man with COVID-19 was admitted to our hospital. The treatment course was favorable, and the COVID-19 treatment was completed by the 10th day. On day 14, pancreatic enzymes increased mildly. An abdominal computed tomography revealed a ruptured left gastric aneurysm after spontaneous hemostasis. Arterial embolization was performed. In this patient, a new left gastric aneurysm was suspected of having formed and ruptured during the course of the COVID-19 treatment. To the best of our knowledge, this is the first report of abdominal visceral aneurysm formation caused by COVID-19 in a medium-sized vessel, and it is necessary to remember that aneurysms can be formed at any site when treating this syndrome.

Giant infected hepatic cyst causing exclusion pancreatitis: A case report.

BACKGROUND: An infected hepatic cyst causes clinical symptoms, such as fever and abdominal pain. A cyst with a diameter > 10 cm increases the likelihood of exclusion symptoms in adjacent organs. Herein, we report a case of pancreatitis caused by an infected hepatic cyst. CASE SUMMARY: The patient was an 88-year-old woman with a history of polycystic liver disease and a cyst > 10 cm in diameter. She was referred to our hospital for upper abdominal pain that persisted for four days before consultation. She had a fever of 37.4ºC, and a blood test showed a C-reactive protein level of 23 mg/dL. An infected hepatic cyst was diagnosed by abdominal ultrasonography, computed tomography, and magnetic resonance imaging. Antibacterial therapy and percutaneous cyst puncture did not elicit sufficient therapeutic effects. As the cyst growth continued, laparoscopic hepatic cyst fenestration was performed on hospitalization day 20. Thereafter, symptoms improved, and she was discharged on hospital day 31. CONCLUSION: To our knowledge, this is the second case report of pancreatitis associated with hepatic cyst growth. Percutaneous cyst puncture and drainage or surgical therapy can be considered if a slight improvement with antibiotic therapy alone or exclusion of surrounding organs is observed. Further, attention is needed to avoid potential recurrence.

The risk scoring system for assessing the technical difficulty of endoscopic submucosal dissection in cases of remnant gastric cancer after distal gastrectomy.

BACKGROUND: Endoscopic submucosal dissection (ESD) for remnant gastric cancer (RGC) after distal gastrectomy (DG) is considered technically challenging due to the narrow working space, and severe fibrosis and staples from the previous surgery. Technical difficulties of ESD for RGC after DG have not been thoroughly investigated. This study aimed to develop and validate a risk-scoring system for assessing the technical difficulty of ESD for RGC after DG in a large multicenter cohort. METHODS: We investigated patients who underwent ESD for RGC after DG in 10 institutions between April 2008 and March 2018. A difficult case was defined as ESD lasting ≥ 120 min, involving piecemeal resection, or the occurrence of perforation during the procedure. A risk-scoring system for the technical difficulty of the procedure was developed based on multiple logistic regression analyses, and its performance was internally validated using bootstrapping. RESULTS: A total of 197 consecutive patients with 201 lesions were analyzed. There were 90 and 111 difficult and non-difficult cases, respectively. The scoring model consisted of four independent risk factors and points of risk scores were assigned for each as follows: tumor size > 20 mm: 2 points; anastomosis site: 2 points; suture line: 1 point; and non-expert endoscopist: 2 points. The C-statistics of the scoring system for technical difficulty was 0.72. CONCLUSIONS: We developed a validated risk-scoring model for predicting the technical difficulty of ESD for RGC after DG that can contribute to its safer and more reliable performance.

Concerns and Anxieties of Patients During Hospitalization for COVID-19.

Objective The objective of this study was to evaluate the concerns and anxieties of hospitalized coronavirus disease (COVID-19) patients. Methods A questionnaire was distributed to patients on discharge. The responses were analyzed once they were returned by mail. Results Responses were received from 27 of 39 patients (average age, 50 ± 17 years). Among the participants, 16 were male (59.3%), 19 were symptomatic (70.4%), and two required a ventilator (7.4%). Anxiety about symptom exacerbation was reported by 36.0% of participants. Quarantine-associated stress was experienced by 60.0% of participants, and 72.0% of participants supported the change in federal policy that allows asymptomatic patients and patients with mild conditions to isolate themselves at a hotel or their home. Following discharge, 44.0% of participants experienced anxieties regarding their lives after discharge, and 56.0% were anxious regarding discrimination and rumors. During hospitalization, 68.0% of participants re-evaluated their attitude toward health, 44.0% regretted the preventative measures they took before contracting COVID-19, and 44.0% felt guilty for becoming infected. Conclusions Participants experienced various kinds of stress related to hospitalization for COVID-19. There was a trend of people being more concerned about their relationships than their own health. Therefore, as asymptomatic participants and participants with mild symptoms also experienced psychological stresses, it is also necessary to consider the psychological and social effects of the disease.

Changes in patients' outlook, behaviors, and attitudes toward COVID-19 after hospitalization and their experiences of discrimination and harassment.

OBJECTIVE: This study aims to examine changes in patients' perspectives and outlooks regarding the disease and their health after hospitalization for COVID-19 and investigate their discrimination and harassment experiences. This prospective observational study surveyed discharged patients who had been admitted to Hyogo Prefectural Tamba Medical Center in Japan for COVID-19. Patient characteristics, changes in outlook and behaviors after discharge, and incidents of discrimination and harassment were examined. The study was conducted in two waves: March-June 2020 and July-September 2020. RESULTS: Responses were obtained from 27 patients aged 50 ± 17 years, including 16 men (59.3%). We found most patients feared infection before hospitalization (88.5%) and had taken some preventive measures (96.3%), however after discharge, all (100%) practiced social distancing and infection prevention. Twenty patients (80%) considered changing their lifestyles, and 19 (79.2%) decided to use sick leave when they felt ill; these trends were more prominent during the second wave. Six patients (23.1%) reported experiencing discrimination or harassment after discharge. While most patients with COVID-19 had a strong fear of infection before hospitalization, their views about health and health behaviors changed after hospitalization.

Humidifier Use and Prone Positioning in a Patient with Severe COVID-19 Pneumonia and Endotracheal Tube Impaction Due to Highly Viscous Sputum.

COVID-19 can lead to severe pneumonia, requiring mechanical ventilation. While increased sputum secretion could cause airway obstruction during mechanical ventilation, there are few reported cases in the literature. We report a case of a 65-year-old man with diabetes and severe COVID-19 pneumonia requiring mechanical ventilation and treated with hydroxychloroquine, azithromycin, nafamostat, and prone positioning. Initially, mechanical ventilation consisted of a heat moisture exchanger, endotracheal tube aspiration, and subglottic secretion drainage using a closed suction system. However, endotracheal tube impaction by highly viscous sputum occurred during this mechanical ventilation system. Replacing the endotracheal tube, the use of a humidifier instead of a heat moisture exchanger, and prone positioning contributed to the patient being weaned off mechanical ventilation. Although anti-aerosol measures are important for severe COVID-19 pneumonia, attention should be given to potential endotracheal tube impaction during mechanical ventilation.

Clinical Factors of Delayed Perforation after Endoscopic Submucosal Dissection for Gastric Neoplasms.

BACKGROUND: Delayed perforation is a rare but severe complication of endoscopic submucosal dissection (ESD) for early gastric neoplasm (EGN). The aim of this study was to clarify clinical factors related to delayed perforation after ESD. METHODS: A total of 1158 consecutive patients with 1199 EGNs underwent ESD at our hospital between January 2000 and December 2015. Univariate analysis was used to identify clinicopathological factors related to delayed perforation. Moreover, duration of cautery needed for hemostasis was measured by comparison between perforated and nonperforated points in patients with delayed perforation. RESULTS: Delayed perforation occurred in 5 of 1158 consecutive patients with 1199 EGNs who underwent ESD (0.42%). All cases were diagnosed within 24 h after ESD and recovered with conservative management. On univariate analysis, location in the upper stomach was the factor most significantly associated with delayed perforation (P < 0.01). Duration of cautery needed for hemostasis was significantly longer at perforated points (9 s) than at nonperforated points (3.5 s) in five patients. CONCLUSIONS: Location in the upper stomach was the risk factor most prominently associated with delayed perforation after ESD for EGNs. In addition, delayed perforation appears associated with excessive electrocautery for hemostasis.

Intractable hiccups caused by esophageal diverticular candidiasis in an immunocompetent adult: a case report.

INTRODUCTION: Various causes of intractable hiccups have been reported; however, to the best of our knowledge, there are no previous reports of either intractable hiccups due to esophageal candidiasis in an immunocompetent adult or improvement following antifungal therapy. CASE PRESENTATION: An 87-year-old man presented with intractable hiccups. Although the patient was immunocompetent, he used proton pump inhibitors. An esophagogastroduodenos-copy revealed several white deposits throughout the esophagus and extensive white deposits in the midesophageal diverticulum. A mucosal culture showed candidiasis, which was suspected to be the cause of the intractable hiccups. After oral fluconazole had been prescribed, the candidiasis resolved and the hiccups improved. Therefore, we concluded that esophageal diverticular candidiasis was the cause of his intractable hiccups. CONCLUSION: Physicians should consider esophageal candidiasis as one of the differential diagnoses for intractable hiccups, even in immunocompetent adults.

Multicenter phase II study of FOLFIRI plus bevacizumab after discontinuation of oxaliplatin-based regimen for advanced or recurrent colorectal cancer (CR0802).

BACKGROUND: To investigate the efficacy and safety of FOLFIRI plus bevacizumab regimen with irinotecan (180 mg/m(2)) in patients with advanced or recurrent colorectal cancer who were of the wild-type or heterozygous group for UGT1A1*28 and *6 polymorphisms and discontinued to oxaliplatin-based regimen, prospectively. METHODS: The study population consisted of patients who had discontinued oxaliplatin-based regimen for any reason. The primary endpoint was the response rate. FOLFIRI and bevacizumab regimen [irinotecan: 180 mg/m(2), 5-fluorouracil infusion: 2400 mg/m(2), 5-fluorouracil bolus: 400 mg/m(2), levofolinate calcium: 200 mg/m(2), bevacizumab: 5 mg/kg] was repeated every 2 weeks for up to 24 cycles. RESULTS: Ninety-four patients were enrolled; 93 patients were evaluated on safety, 94 patients on efficacy. The response rate was 10.1% (95% confidence interval (CI): 4.7-18.3%). The median time to treatment failure, progression-free survival, and overall survival were 4.1 months (95% CI: 2.8-4.8 months), 5.4 months (95% CI: 4.1-6.2 months), and 14.5 months (95% CI: 11.8-17.0 months), respectively. The treatment-related death was 1.1%, and the early death ≤30 days after the last study treatment was 1.1%. The incidence of grade 3 or higher adverse events was 60.2% for neutropenia, 23.7% for leukopenia, 9.7% for diarrhea, 6.5% for anorexia, and 5.4% for fatigue. All these adverse events and other adverse events were controllable. CONCLUSIONS: FOLFIRI plus bevacizumab regimen with an initial irinotecan dose of 180 mg/m(2) exhibited an adequate antitumor effect and was confirmed to be manageable and tolerable in Japanese patients with advanced or recurrent colorectal cancer, who had discontinued oxaliplatin-based regimen. TRIAL REGISTRATION: UMIN000001817 .

Polypoid leiomyosarcoma of the esophagus treated by endoscopic submucosal dissection.

We report a rare case of polypoid leiomyosarcoma of the esophagus that was treated by endoscopic submucosal dissection (ESD). A 63-year-old man with complaints of progressive dysphagia was referred to Hyogo Cancer Center for treatment of esophageal tumor. Esophagoscopy revealed a polypoid tumor 25 mm in diameter on the left side of the upper esophagus. Despite several biopsy specimens, the diagnosis could not be confirmed. Computed tomography showed a protruded, homogeneously enhancing mass in the upper esophagus, but no lymph node enlargement or metastasis. After 1.5 months, the esophagogram showed a filling defect 47 mm in diameter in the upper esophagus. Given this rapid tumor growth, en bloc resection was done by ESD for therapeutic diagnosis. After this treatment, the tumor seemed to grow larger, showing a short stalk and occupying the esophageal lumen. Histopathologically, the tumor comprised pleomorphic spindle cells with mitosis. Tumor invasion involved the lumina propria mucosae and contact with the muscularis mucosae, but not involving the submucosa. Immunohistochemical examination showed positive staining for smooth muscle actin and HHF35, but negative for desmin, caldesmon, CD34, c-kit, DOG1, ALK, S-100 protein and cytokeratin. These histopathological findings were compatible with a diagnosis of esophageal leiomyosarcoma derived from the muscularis mucosae.

A novel serum metabolomics-based diagnostic approach to pancreatic cancer.

BACKGROUND: To improve the prognosis of patients with pancreatic cancer, more accurate serum diagnostic methods are required. We used serum metabolomics as a diagnostic method for pancreatic cancer. METHODS: Sera from patients with pancreatic cancer, healthy volunteers, and chronic pancreatitis were collected at multiple institutions. The pancreatic cancer and healthy volunteers were randomly allocated to the training or the validation set. All of the chronic pancreatitis cases were included in the validation set. In each study, the subjects' serum metabolites were analyzed by gas chromatography mass spectrometry (GC/MS) and a data processing system using an in-house library. The diagnostic model constructed via multiple logistic regression analysis in the training set study was evaluated on the basis of its sensitivity and specificity, and the results were confirmed by the validation set study. RESULTS: In the training set study, which included 43 patients with pancreatic cancer and 42 healthy volunteers, the model possessed high sensitivity (86.0%) and specificity (88.1%) for pancreatic cancer. The use of the model was confirmed in the validation set study, which included 42 pancreatic cancer, 41 healthy volunteers, and 23 chronic pancreatitis; that is, it displayed high sensitivity (71.4%) and specificity (78.1%); and furthermore, it displayed higher sensitivity (77.8%) in resectable pancreatic cancer and lower false-positive rate (17.4%) in chronic pancreatitis than conventional markers. CONCLUSIONS: Our model possessed higher accuracy than conventional tumor markers at detecting the resectable patients with pancreatic cancer in cohort including patients with chronic pancreatitis. IMPACT: It is a promising method for improving the prognosis of pancreatic cancer via its early detection and accurate discrimination from chronic pancreatitis.

Phase I study of photodynamic therapy using talaporfin sodium and diode laser for local failure after chemoradiotherapy for esophageal cancer.

BACKGROUND: Photodynamic therapy (PDT) is a less invasive and effective salvage treatment for local failure after chemoradiotherapy (CRT) for esophageal cancer, however it causes a high rate of skin phototoxicity and requires a long sun shade period. Talaporfin sodium is a rapidly cleared photosensitizer that is expected to have less phototoxicity. This study was undertaken to clarify the optimum laser fluence rate of PDT using talaporfin sodium and a diode laser for patients with local failure after CRT or radiotherapy (RT) for esophageal cancer. METHODS: This phase I, laser dose escalation study used a fixed dose (40 mg/m²) of intravenous talaporfin sodium administered 4 to 6 hours before irradiation in patients with local failure limited to T2 after CRT or RT (≥ 50 Gy). The primary endpoint was to assess the dose limiting toxicity (DLT) of PDT, and the secondary endpoints were to evaluate the adverse events and toxicity related to PDT. The starting fluence of the 664 nm diode laser was 50 J/cm², with an escalation plan to 75 J/cm² and 100 J/cm². RESULTS: 9 patients with local failure after CRT or RT for ESCC were enrolled and treated in groups of 3 individuals to the third fluence level. No DLT was observed at any fluence level. Phototoxicity was not observed, but one subject had grade 1 fever, three had grade 1 esophageal pain, and 1 had grade 1 dysphagia. Five of 9 patients (55.6%) achieved a complete response after PDT. CONCLUSIONS: PDT using talaporfin sodium and a diode laser was safe for local failure after RT in patients with esophageal cancer. The recommended fluence for the following phase II study is 100 J/cm².