Suprapapillary placement of plastic versus metal stents for malignant biliary hilar obstructions: a multicenter, randomized trial.

BACKGROUND AND AIMS: The efficacy of the suprapapillary placement of inside plastic stents (iPSs) for unresectable malignant hilar biliary obstructions (MHOs) is unknown compared with that of uncovered inside metal stents (iMSs). This randomized controlled trial was designed to evaluate the outcomes of endoscopic placement of these stents for unresectable MHOs. METHODS: This open-label, randomized study was conducted at 12 Japanese institutions. The enrolled patients with unresectable MHOs were allocated to iPS and iMS groups. The primary outcome was defined as the time to recurrent biliary obstruction in patients for whom the intervention was both technically and clinically successful. RESULTS: Among 87 enrollments, 38 patients in the iPS group and 46 patients in the iMS group were analyzed. Technical success rates were 100% (38 of 38) and 96.6% (44 of 46), respectively (P = 1.00). After transferring 1 unsuccessful iMS-group patient to the iPS group (since iPSs were deployed), the clinical success rates were 90.0% (35 of 39) for the iPS group and 88.9% (40 of 45) for the iMS group from a per-protocol analysis (P = 1.00). Among the patients with clinical success, the median times to recurrent biliary obstruction were 250 (95% confidence interval, 85-415) and 361 (95% confidence interval, 107-615) days (log-rank test, P = .34). No differences were detected in rates of adverse events. CONCLUSIONS: This Phase II randomized trial did not show any statistically significant difference in stent patency between suprapapillary plastic versus metal stents. Considering the potential advantages of plastic stents for malignant hilar obstruction, these findings suggest that suprapapillary plastic stents could be a viable alternative to metal stents for this condition.

Muscular metastasis of superficial esophageal squamous cell carcinoma: a rare case of recurrence after endoscopic submucosal dissection with additional chemoradiotherapy.

Esophageal cancer after endoscopic treatment may recur depending on the risk. We present a case of a rare T1b esophageal cancer after endoscopic treatment plus chemoradiotherapy (CRT) that recurred with metastasis of the dorsal muscles. A 70-year-old man was referred for treatment of early-stage esophageal carcinoma. Endoscopic submucosal dissection (ESD) was performed and histopathology showed a poorly differentiated squamous cell carcinoma with invasion to the submucosal layer (sm2) with INFc-type invasion and positive venous invasion. After subsequent CRT, the patient was monitored every 6 months, using computed tomography (CT) and endoscopy. Fifteen months after the treatment, contrast CT revealed a spherical mass with 9 cm ring enhancement within the right erector spinae, that had squamous cell carcinoma confirmed by CT-guided biopsy. Radiation and systemic chemotherapy were initiated for the metastasis of the esophageal carcinoma. However, he died of respiratory failure due to rapid pleural effusion 26 months after ESD. Pathological autopsy showed diffuse squamous cell carcinoma invasion of the cystic wall, forming a lumbar mass, and absence of cancer cell remnants or recurrences in the esophagus. This case report emphasizes the need for systemic observation of superficial esophageal cancer after treatment with a high risk of recurrence.

Impact of COVID-19 on the endoscopy department since the early phase of the pandemic in 2020: A questionnaire study among patients with canceled examinations at a single Japanese institution.

INTRODUCTION: In early 2020, the Japanese government declared a nationwide state of emergency for the COVID-19 pandemic. We investigated the impact of the emergency declaration on endoscopy adherence and conducted a follow-up study of patients with canceled examinations at a tertiary endoscopy facility in Japan in 2020. METHODS: We compared the number of endoscopies performed, and cancelations at the endoscopy unit between 2019 and 2020 and used the Bayesian structural time series (BSTS) model to estimate the decrease in the number of endoscopies in 2020. We administered a questionnaire to those who had not undergone a scheduled endoscopy. RESULTS: Of 14 146 and 13 338 scheduled examinations, 1233 (8.7%) and 1403 (10.5%) were canceled in 2019 and 2020, respectively. During both years, age < 50 years, age > 80 years, upper endoscopy, and experience of endoscopy in the past 5 years were significantly associated with cancelations. In 2020, cancelations in the 14th-26th week of the year, including the period of state of emergency, increased significantly, and more women canceled. Of the 409 questionnaire-respondents, 174 (42.5%) indicated that COVID-19 had influenced their cancelation, and 315 (77.0%) had not undergone similar endoscopic examinations since then. The BSTS model predicted a decrease of 957 (95% CI -1213 to -708, P = .003) examinations. CONCLUSION: In 2020, despite low numbers of COVID-19 cases in the study site, the number of endoscopies decreased, and cancelation increased. Further research is needed on the future impact of a decrease in the number of endoscopies during a COVID-19 pandemic.

Assigning a different endoscopist for each annual follow-up may contribute to improved gastric cancer detection rates.

Background and study aims Esophagogastroduodenoscopy (EGD) is an effective and important diagnostic tool to detect gastric cancer (GC). Although previous studies show that examiner, patient, and instrumental factors influence the detection of GC, we analyzed whether assigning a different examiner to surveillance EGD would improve the detection of GC compared to assigning the same examiner as in the previous endoscopy. Patients and methods We retrospectively reviewed patients who underwent two or more consecutive surveillance EGDs at a single center between 2017 and 2019. We identified factors associated with GC detection using multivariable regression analysis and propensity-score matching. Results Among 7794 patients, 99 GC lesions in 93 patients were detected by surveillance EGD (detection rate; 1.2 %), with a mean surveillance interval of 11.2 months. Among the detected 99 lesions, 87 (87.9 %) were curatively treated with endoscopy. There were no differences in the clinicopathologic characteristics of GC detected by the same or different endoscopists. GC detection in the group examined by different endoscopists was more statistically significant than in the group examined by the same endoscopist, even after propensity-score matching (1.6 % and 0.7 %; P  < 0.05). Endoscopic experience and other factors were not statistically significant between the two groups. Conclusions In surveillance EGD, having a different endoscopist for each exam may improve GC detection rates, regardless of the endoscopist's experience.

Needle tract seeding after endoscopic ultrasound-guided tissue acquisition of pancreatic tumors: A nationwide survey in Japan.

OBJECTIVES: Endoscopic ultrasound-guided tissue acquisition (EUS-TA) plays a crucial role in the diagnosis of pancreatic tumors. The present study aimed to investigate the current status of needle tract seeding (NTS) after EUS-TA of pancreatic tumors based on a nationwide survey in Japan. METHODS: Patients who underwent surgical resection of primary pancreatic tumors after EUS-TA performed between April 2010 and March 2018 were surveyed. The incidence rates of NTS were determined, and compared in patients with pancreatic ductal adenocarcinomas (PDACs) and other tumors, and in patients who underwent transgastric and transduodenal EUS-TA of PDACs. The detailed features and prognosis of patients with NTS were also assessed. RESULTS: A total of 12,109 patients underwent surgical resection of primary pancreatic tumors after EUS-TA. The overall incidence rate of NTS was 0.330%, and the NTS rate was significantly higher in patients with PDAC than in those with other tumors (0.409% vs. 0.071%, P=0.004). NTS was observed in 0.857% of patients who underwent transgastric EUS-TA, but in none of those who underwent transduodenal EUS-TA. Of the patients with NTS of PDACs, the median time from EUS-TA to occurrence of NTS and median patient survival were 19.3 and 44.7 months, respectively, with 97.4% of NTS located in the gastric wall and 65.8% of NTS resected. The patient survival was significantly longer in patients who underwent NTS resection than in those without NTS resection (P=0.037). CONCLUSIONS: NTS appeared only after transgastric not after transduodenal EUS-TA. Careful follow-up provides an opportunity to remove localized NTS lesions by gastrectomy.

Novel anchoring device for endoscopic ultrasound-guided gallbladder drainage: Secondary publication.

BACKGROUND: Recently, endoscopic ultrasound-guided gallbladder drainage has attracted much attention. However, the risk management of adverse events and techniques to avoid them are not yet mature. Difficulty dilating the fistula with a dilator or placing a stent for drainage often prolongs the procedure time, which increases the risk of peritonitis or the procedure failure rate. Therefore, the result of the procedure will be unstable, and one cause is the lack of adhesion between the gallbladder and the digestive tract walls. METHODS: We developed an anchor to fix the stomach and gallbladder walls prior to endoscopic ultrasound-guided gallbladder drainage in four live pigs using the anchor. RESULTS: The stomach and gallbladder walls were fixed in three pigs, and technical success was achieved in all three pigs. In two pigs that were dissected 17 and 34 days post-procedure, respectively, fixation occurred in one pig. In the other pig, anchoring of the gallbladder and stomach walls did not occur because the wings of the anchor in the gallbladder were damaged. CONCLUSIONS: Although issues remain regarding efficacy and safety, we plan to make improvements in this novel device and aim for clinical application.

The risks and characteristics of the delayed bleeding after endoscopic submucosal dissection for early gastric carcinoma in cases with anticoagulants.

BACKGROUND: Endoscopic submucosal dissection (ESD) is a minimally invasive treatment for early gastric carcinoma. Vitamin K antagonists and direct oral anticoagulants (DOAC) were reported to increase the risk of delayed bleeding after ESD. However, the evaluation of ESD cases taking anticoagulants is scarce. We analyzed the risk and characteristics of delayed bleeding after gastric ESD in patients on anticoagulants. METHODS: We performed a retrospective observational study at a single center. Consecutive patients who underwent ESD for early gastric carcinoma and took anticoagulants, including warfarin, rivaroxaban, dabigatran, apixaban, and edoxaban, between January 2012 and December 2018, were analyzed. We also calculated delayed bleeding rates for those without anticoagulants. RESULTS: Of 1855 eligible patients who underwent gastric ESDs, 143 took anticoagulants. Delayed bleeding occurred in 30 (21.0%) cases taking anticoagulants, with 15 (19.5%) cases in the DOAC group [rivaroxaban, seven cases (21.2%); dabigatran, four cases (20.0%); apixaban, four cases (23.5%); and edoxaban, zero cases (0%)] and 15 cases (22.7%) in the warfarin group. Furthermore, 43/344 (12.5%) patients taking antiplatelets and 76/1368 (5.6%) patients without antithrombic drugs experienced delayed bleeding. Multivariable logistic analysis revealed post-heart valve replacement (OR, 6.56; 95% CI, 1.75-24.7; p < .05) as a risk for delayed bleeding in warfarin-taking patients, while no statistically significant factor was found in DOAC-taking patients. CONCLUSIONS: Anticoagulants were associated with a high incidence of severe delayed bleeding. Careful attention should be paid to patients on anticoagulants after gastric ESD, especially those on warfarin after heart valve replacement.

The sub-classification of type B2 vessels according to the magnifying endoscopic classification of the Japan Esophageal Society.

OBJECTIVES: Guidelines for magnified endoscopic diagnosis of esophageal squamous cell carcinoma (SCC) have been proposed by the Japan Esophageal Society. Type B1, B2, and B3 reflect increasing tumor invasion depths (within mucosal epithelium or into lamina propria mucosa [T1a-EP/LPM], into muscularis mucosa or superficial invasion into submucosa [T1a-MM/T1b-SM1], and into submucosa [T1b-SM2], respectively). The diagnostic accuracy of type B1 and B3 is high, but accuracy of type B2 is low. We aimed to improve the diagnostic accuracy of type B2. METHODS: We retrospectively reviewed 248 SCC lesions treated with endoscopic submucosal dissection between January 2012 and July 2018 and identified the B2 lesions. The maximum diameter of the area presenting B2 was measured and evaluated in relation to tumor invasion, for which receiver-operating characteristic (ROC) curves were generated. The optimal area size for distinguishing T1a-EP/LPM from T1a-MM or deeper invasion was determined. RESULTS: There were 78 lesions with B2, of which 26 (33%) were T1a-MM or T1b-SM1 SCCs. ROC curve analysis indicated that the optimal cut-off for the target area showing B2 was 4 mm. The invasion depth (EP/LPM: MM/SM1: SM2) of B2 observed in an area with a diameter <4 mm (B2-Narrow) and those with diameter ≥4 mm (B2-Broad) was 46:11:1 and 1:15:4, respectively. To predict T1a-MM or deeper invasion, B2-Broad had a sensitivity, specificity, positive predictive value, and negative predictive value of 61%, 98%, 95%, and 79%, respectively. CONCLUSION: The diagnostic accuracy of type B2 was improved by evaluating the area of type B2.

Secondary aortoenteric fistula possibly associated with continuous physical stimulation: a case report and review of the literature.

BACKGROUND: Secondary aortoenteric fistula is a rare but fatal complication after reconstructive surgery for an aortic aneurysm characterized by abdominal pain, fever, hematochezia, and hematemesis, and the mortality rate is high. It has been suggested that it arises due to either continuous physical stimulation or prosthesis infection during primary surgery. We describe an aortoenteric fistula following reconstructive surgery for an abdominal aortic aneurysm together with postmortem pathological findings. CASE PRESENTATION: A 59-year-old Japanese man who had undergone reconstructive surgery for an abdominal aortic aneurysm 20 months earlier presented with the chief complaint of hematochezia and malaise. Esophagogastroduodenoscopy and total colonoscopy revealed only colon diverticula with no bleeding. Contrast-enhanced computed tomography revealed gas within the aneurysm sac and adhesion between the replaced aortic graft and intestinal tract, suggesting a graft infection. After 18 days of antibiotic treatment, he suddenly went into a state of shock, with massive fresh bloody stool and hematemesis, followed by cardiac arrest. An autopsy revealed communication between the artery and the ileum through an ulcerative fistula at the suture line between the left aortic graft branch and the left common iliac artery. Pathological analysis revealed tight adherence between the arterial and intestinal walls, but no marked sign of infection around the fistula, suggesting that the fistula had arisen due to physical stimuli. CONCLUSIONS: Pathological analysis suggested that the present secondary aortoenteric fistula arose due to physical stimuli. This reaffirms the importance of keeping reconstructed aortas isolated from the intestine after abdominal aortic aneurysm surgery.

Preoperative endoscopic ultrasonography-guided tattooing of the pancreas with a minuscule amount of marking solution using a newly designed injector.

BACKGROUND AND AIM: Recent studies have reported the usefulness of preoperative endoscopic ultrasonography-guided fiducial tattooing (EUS-tattooing) of the pancreas. However, problems of proper procedure, including markers and amounts, have not been resolved. The aim of the present study was to evaluate the feasibility of EUS-tattooing with a minuscule amount of marking solution using a new injector. METHODS: Six consecutive patients who underwent EUS-tattooing between June 2013 and April 2015 at our center were retrospectively analyzed (mean age, 60.7 years; males, 4). A 25-gauge needle was inserted into the surface of the pancreas near the tumor with EUS guidance. Then, 0.02 mL marking solution was injected three to five times (maximal total amount was defined as 0.1 mL). The marking solution used in this study was a compound of aqueous solution of sodium hyaluronate and India ink with proportions of 4 to 1. The newly developed injector for precise injection of minuscule amount of solution was used. RESULTS: All six patients were successfully injected with the intended amount of marking solution. The tattoo mark was easily detected during surgery and localized in a small area in five patients. In one patient, however, the tattoo mark was not detected during surgery. There were no adverse events, including bleeding, perforation, and acute pancreatitis, by EUS-tattooing. CONCLUSIONS: EUS-tattooing with a minuscule amount of marking solution using the newly developed injector was feasible and seemed useful and relatively safe. Further studies are warranted to confirm the safety and efficacy of EUS-tattooing.