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Background and Aims Although endoscopic submucosal dissection (ESD) has been applied for superficial pharyngeal cancer, no prospective trials have been reported. To investigate the efficacy and safety of ESD for superficial pharyngeal cancer, we conducted a prospective phase II trial. Methods Fifty-four patients with 73 lesions were enrolled from September 2010 to August 2014, and ESD was performed. The primary endpoint was the complete resection rate. Secondary endpoints were safety, recurrence-free survival, overall survival, and incidence of metachronous pharyngeal cancer. Results Fifty-four patients had stage 0-III cancer: stage 0, n = 22; stage I, n = 14; stage II, n = 17; and stage III, n = 1. The en bloc resection rate was 100%, and the complete resection rate was 79.5% (58/73 lesions; 95% confidence interval, 68%-88%). No serious adverse events related to ESD were encountered. Four patients required nasogastric intubation and feeding. No patients required percutaneous endoscopic gastrostomy and tracheotomy. Swallowing, speech, and airway functions were preserved in all patients. One of the 54 patients died of an unrelated illness. Median follow-up was 27 months (range 6-55 months). Local cervical lymph node metastasis was observed in 1 patient, and the case was salvaged successfully with lymph node dissection. The 3-year overall and recurrence-free survival rates were 97.7% and 98.1%, respectively. Cumulative development of multiple cancers of the pharynx at 3 years was 18.4%. Conclusions ESD appears to be a safe and effective minimally invasive treatment in patients with superficial pharyngeal cancer. (Clinical trial registration number: UMIN000003623.) [ABSTRACT FROM AUTHOR]

Background: Perforation is a common complication of endoscopic submucosal dissection (ESD), but little is known about the relevant risk factors. Objective: To investigate the risk factors for perforation. Design: Retrospective study. Setting: A cancer referral center. Patients: A total of 1795 early gastric tumors in 1500 patients treated by ESD from July 2002 to December 2010 were included in the analysis. Main Outcome Measurements: The associations between the incidence of perforation and patient and lesion characteristics were investigated. Results: Perforation during ESD occurred in 50 lesions (2.8%). Univariate analysis identified tumor location (upper, middle, or lower stomach), tumor diameter (≤20 or >20 mm), and treatment period (lesions treated in the first or second period) as predictors of perforation. Multivariate analysis identified tumor location (upper stomach), tumor diameter (>20 mm), and treatment period (first half) as independent risk factors for perforation. The odds ratios were 2.4 (95% CI, 1.3-4.7; P = .006) for lesions in the upper stomach and 1.9 (95% CI, 1.0-3.5; P = .04) for lesions larger than 20 mm. Perforation risks were 5.4% for lesions in the upper stomach and 4.4% for lesions larger than 20 mm. Three patients required emergency surgery, but the rest of the patients were successfully treated with endoscopic clipping. There was no perforation-related mortality. Limitations: Single-center, retrospective study design. Conclusions: Lesions in the upper stomach and lesions larger than 20 mm were independent risk factors for perforation during ESD. Patients should be made aware of the estimated high risks of these lesions before undergoing ESD. [Copyright &y& Elsevier]

Background: Colonoscopy is one of the most reliable methods for detection of colorectal neoplasms, but conventional colonoscopy can miss some lesions. Objective: To evaluate the efficacy of autofluorescence imaging (AFI) with a transparent hood (TH) for detection of colorectal neoplasms. Design: A 2 × 2 factorial designed, prospective, randomized, controlled trial. Setting: This study was conducted at the Osaka Medical Center for Cancer and Cardiovascular Diseases, a tertiary cancer center. Patients: A total of 561 patients. Interventions: Patients were allocated to 1 of 4 groups: (1) white light imaging (WLI) alone—colonoscopy using WLI without a TH; (2) WLI+TH—colonoscopy using WLI with a TH; (3) AFI alone—colonoscopy using AFI without a TH; and (4) AFI+TH—colonoscopy using AFI with a TH. Eight colonoscopists used each allocated method. Main Outcome Measurement: The difference in neoplasm detection rate (number of detected neoplasms per patient) between the WLI alone and AFI+TH groups. Results: Neoplasm detection rate (95% confidence interval) in the AFI+TH group was significantly higher than in the WLI alone group (1.96 [1.50-2.43] vs 1.19 [0.93-1.44]; P = .023, Tukey-Kramer multiple comparison test). Relative detection ratios (95% confidence interval) for polypoid neoplasms based on Poisson regression model were significantly increased by mounting a TH (1.69 [1.34-2.12], P < .001), and relative detection ratios for flat neoplasms were significantly increased by AFI observation (1.83 [1.24-2.71], P = .002). Limitations: Open trial performed in single cancer referral center. Conclusion: AFI colonoscopy with a TH detected significantly more colorectal neoplasms than did conventional WLI colonoscopy without a TH. (Clinical trial registration number: UMIN000001473.) [Copyright &y& Elsevier]

Background: After endoscopic submucosal dissection (ESD) for early gastric cancer (EGC), delayed bleeding occurs in 1.7% to 38% of cases. Routine coagulation of all nonbleeding visible vessels (NBVVs) in post-ESD ulcers is currently performed as standard practice, but it cannot eliminate bleeding. An endoscopic Doppler US (DOP-US) probe system has possible benefits for the prediction of recurrent bleeding in peptic ulcer hemorrhage. Objective: To establish optimum use and evaluate feasibility of DOP-US for post-ESD ulcers. Design: Case series study. Setting: Cancer referral center. Patients: Eight patients with mucosal EGC larger than 2 cm without ulceration or scarring and 2 patients with EGC less than 3 cm with scarring. Interventions: We searched for a positive DOP-US signal (DOP-US+), which was defined as pulsatile sound at a depth of 1.5 mm, and NBVVs or areas with DOP-US+ were coagulated with hemostatic forceps. A multibending, double-channel videoendoscope that was fitted with a transparent hood was used. Main Outcome Measurements: Detectability of DOP-US signals in post-ESD ulcers. Results: One of 13 oozing bleeding sites, 24 (18%) of 136 NBVVs, and 7 areas without any bleeding stigmata had DOP-US+ and were coagulated until the signal became silent. One hundred twelve NBVVs (82%) and 8 adherent clots without DOP-US signals were left untreated. No delayed bleeding was experienced at 30 days. Median time required for Doppler examination was 34 minutes, but it improved to 18 and 19 minutes in patients 9 and 10, respectively. Conclusions: DOP-US might be helpful in the endoscopic management of post-ESD ulcers in EGC. Our setting and maneuver warrant further investigation to clarify whether DOP-US can reduce delayed bleeding and avoid unnecessary coagulation for NBVVs in post-ESD ulcers. [ABSTRACT FROM AUTHOR]

Background: EMR is now a widely accepted option for the treatment for superficial esophageal cancer (SEC). However, studies of medium-term to long-term outcomes are scarce. Objective: To evaluate outcomes in patients with SEC who are undergoing medium-term to long-term follow-up after endoscopic oblique aspiration mucosectomy (EOAM). Design: A single-center retrospective study. Setting: Kitasato University East Hospital, Sagamihara, Kanagawa, Japan. Patients and Interventions: From November 1999 to October 2005, 85 patients with SEC underwent EOAM. All tumors were macroscopically classified as the superficial type on the basis of preoperative endoscopic and EUS findings. Patients were followed-up, with an endoscopy every 6 months. Main Outcome Measurements: Therapeutic efficacy, complications, and follow-up results. Results: The rate of complete resection was 82.5% (70/85). In patients who underwent an incomplete resection, argon plasma coagulation and heat probe coagulation were, in addition, performed. The median longest diameter of the resected specimens was 25 mm. The median time required for a resection was 27 minutes. There was no perforation. Bleeding after an EOAM occurred in 1 patient (1.2%). Esophageal stenosis developed in 8 patients (9.4%). All strictures were managed by endoscopic balloon dilation, and symptoms improved. The median follow-up period after EMR was 36 months (range 6-72 months). Local recurrence occurred in 5 patients (5.9%); the nonrecurrence rate was 96.4% at 1 year, 95.0% at 2 years, and 93.4% at 3 years. As additional treatment, argon plasma coagulation was performed in 4 patients, and endoscopic mucosal dissection was conducted in 1 patient. Conclusions: EOAM is a safe, easy, and effective procedure for the treatment of SEC that can be completed within a short time. The rate of local recurrence is low on medium-term to long-term follow-up. [Copyright &y& Elsevier]

Esophagectomy is the standard treatment for stage I esophageal squamous cell carcinoma (ESCC). We conducted a single-arm prospective study to confirm the efficacy and safety of selective chemoradiotherapy (CRT) based on findings from endoscopic resection (ER). We performed a prospective study of patients with T1b (SM1–2) N0M0 thoracic ESCC from December 2006 through July 2012; 176 patients underwent ER. Based on the findings from ER, patients received the following: no additional treatment for patients with pT1a tumors with a negative resection margin and no lymphovascular invasion (group A); prophylactic CRT with 41.4 Gy delivered to locoregional lymph nodes for patients with pT1b tumors with a negative resection margin or pT1a tumors with lymphovascular invasion (group B); or definitive CRT (50.4 Gy) with a 9-Gy boost to the primary site for patients with a positive vertical resection margin (group C). Chemotherapy comprised 5-fluorouracil and cisplatin. The primary end point was 3-year overall survival in group B, and the key secondary end point was 3-year overall survival for all patients. If lower limits of 90% confidence intervals for the primary and key secondary end points exceeded the 80% threshold, the efficacy of combined ER and selective CRT was confirmed. Based on the results from pathology analysis, 74, 87, and 15 patients were categorized into groups A, B, and C, respectively. The 3-year overall survival rates were 90.7% for group B (90% confidence interval, 84.0%–94.7%) and 92.6% in all patients (90% confidence interval, 88.5%–95.2%). In a prospective study of patients with T1b (SM1–2) N0M0 thoracic ESCC, we confirmed the efficacy of the combination of ER and selective CRT. Efficacy is comparable to that of surgery, and the combination of ER and selective CRT should be considered as a minimally invasive treatment option. UMIN-Clinical Trials Registry no.: UMIN000000553. [ABSTRACT FROM AUTHOR]