Risk scoring system for the preprocedural prediction of the clinical failure of peroral endoscopic myotomy: a multicenter case-control study.

BACKGROUND: Peroral endoscopic myotomy (POEM) is effective for the management of achalasia and its variants; however, it can be ineffective in some patients. We aimed to develop and validate a risk scoring system to predict the clinical failure of POEM preoperatively. METHODS: Consecutive patients who underwent POEM in 14 high volume centers between 2010 and 2020 were enrolled in this study. Clinical failure was defined as an Eckardt score of ≥ 4 or retreatment. A risk scoring system to predict the short-term clinical failure of POEM was developed using multivariable logistic regression and internally validated using bootstrapping and decision curve analysis. RESULTS: Of the 2740 study patients, 112 (4.1 %) experienced clinical failure 6 months after POEM. Risk scores were assigned for three preoperative factors as follows: preoperative Eckardt score (1 point), manometric diagnosis (-4 points for type II achalasia), and a history of prior treatments (1 point for pneumatic dilation or 12 points for surgical/endoscopic myotomy). The discriminative capacity (concordance statistics 0.68, 95 %CI 0.62-0.72) and calibration (slope 1.15, 95 %CI 0.87-1.40) were shown. Decision curve analysis demonstrated its clinical usefulness. Patients were categorized into low (0-8 points; estimated risk of clinical failure < 5 %) and high risk (9-22 points; ≥ 5 %) groups. The proportions of clinical failure for the categories were stratified according to the mid-term outcomes (log-rank test, P < 0.001). CONCLUSIONS: This risk scoring system can predict the clinical failure of POEM preoperatively and provide useful information when making treatment decisions.

Risks of refractory chest pain after peroral endoscopic myotomy in achalasia-related esophageal motility disorders: short-term results from a multicenter study in Japan.

BACKGROUND AND AIMS: The etiology of chest pain in achalasia-related esophageal motility disorders and the frequency and risk factors of persistent chest pain after peroral endoscopic myotomy (POEM) remain unclear. METHODS: A multicenter cohort study including 14 hospitals was conducted to elucidate the characteristics of patients with chest pain and the efficacy of POEM. RESULTS: Consecutive cases of achalasia-related esophageal motility disorders included 2294 (64.2%) and 1280 (35.8%) patients with and without chest pain, respectively. Among the 2107 patients with chest pain who underwent POEM, we observed complete remission in 1464 patients (69.5%) and nonremission in 643 patients (30.5%), including a partial response in 619 patients (29.4%) and resistance in 24 patients (1.1%). Multivariate analysis revealed that advanced age (odds ratio [OR], .28), male sex (OR, .70), prior treatment (OR, 1.39), and sigmoid type (OR, .65) were related to the prevalence of chest pain. Long disease duration (OR, .69) and esophageal dilation (OR, .79) were related to decreased severity. POEM improved patients' quality of life that was hindered by chest pain. Early onset (OR, 1.45), advanced age (OR, .58), male sex (OR, .79), prior treatment (OR, 1.37), and posterior myotomy (OR, 1.42) were associated with nonremission after POEM; high-resolution manometry (HRM) findings and myotomy length showed no statistical significance on pain etiology and persistence after POEM. CONCLUSIONS: The prevalence and severity of chest pain were dependent on age, sex, disease duration, prior treatment, and esophageal morphology rather than HRM findings. The efficacy of POEM is satisfactory; however, residual pain was often observed. Excessively long myotomy can be avoided, and anterior myotomy may be recommended.

Risk factors and long-term course of gastroesophageal reflux disease after peroral endoscopic myotomy: A large-scale multicenter cohort study in Japan.

BACKGROUND : Gastroesophageal reflux disease (GERD) and reflux esophagitis remain problems after peroral endoscopic myotomy (POEM). This study aimed to elucidate the risk factors and long-term course of reflux esophagitis and symptomatic GERD after POEM. METHODS : This multicenter cohort study involved 14 high volume centers. Overall, 2905 patients with achalasia-related esophageal motility disorders treated with POEM were analyzed for reflux esophagitis, severe reflux esophagitis (Los Angeles classification C or D), and symptomatic GERD. RESULTS : Reflux esophagitis was diagnosed in 1886 patients (64.9 %). Age ≥ 65 years (risk ratio [RR] 0.85), male sex (RR 1.11), posterior myotomy (RR 1.12), esophageal myotomy > 10 cm (RR 1.12), and gastric myotomy > 2 cm (RR 1.17) were independently associated with reflux esophagitis. Severe reflux esophagitis was diagnosed in 219 patients (7.5 %). Age ≥ 65 years (RR 1.72), previous treatments (RR 2.21), Eckardt score ≥ 7 (RR 0.68), sigmoid-type achalasia (RR 1.40), and esophageal myotomy > 10 cm (RR 1.59) were factors associated with severe reflux esophagitis. Proton pump inhibitors (PPIs) were more effective for reflux esophagitis at 5-year follow-up (P = 0.03) than after 1 year (P = 0.08). Symptomatic GERD was present in 458 patients (15.9 %). Symptom duration ≥ 10 years (RR 1.28), achalasia diagnosis (RR 0.68), integrated relaxation pressure ≥ 26 (RR 0.60), and posterior myotomy (RR 0.80) were associated with symptomatic GERD. The incidence of symptomatic GERD was lower at 5-year follow-up compared with that after 1 year (P = 0.04), particularly in PPI users (P < 0.001). CONCLUSIONS : The incidence of severe reflux esophagitis was low after POEM, but excessive myotomy for older patients with previous treatments should be avoided. Early phase symptomatic GERD is non-acid reflux dependent and the natural course is favorable, basically supporting conservative treatment.

Linked Color Imaging (LCI) Emphasizes the Color Changes in the Gastric Mucosa After Helicobacter pylori Eradication.

BACKGROUND: Diffuse redness is a characteristic endoscopic finding that indicates current infection of Helicobacter pylori, which is reduced after successful eradication. Linked color imaging (LCI) has been reported to improve the visibility of diffuse redness compared to white light imaging (WLI); however, quantitative evaluation has not been reported. AIMS: This study aimed to objectively evaluate the color change of the gastric mucosa after H. pylori eradication. METHODS: Images of the greater curvature of the antrum and corpus were captured, and the sites were biopsied during esophagogastroduodenoscopy (EGD) before and 1 year after eradication. The region of interest (ROI) was set around the biopsied area on the images. The color difference (ΔE) before and after eradication was calculated using the CIE L*a*b* color space. The association between the histological evaluation and the color value of the corresponding ROI was determined. RESULTS: At the antrum, there was no significant color change with either mode. At the corpus, the a* value, which reflected redness, decreased significantly after eradication with both modes (WLI: 41.2 to 36.0, LCI: 37.5 to 25.5); the b* value, reflecting yellowish, decreased with WLI, but increased significantly with LCI (WLI: 44.6 to 41.6, LCI: 23.9 to 29.2). The ΔE was significantly larger with LCI than with WLI (16.5 vs. 8.6). The a* values at the corpus were generally associated with histological neutrophil infiltration. CONCLUSIONS: Quantitative evaluation revealed that LCI emphasizes the change in color of the gastric mucosa due to the reduction in diffuse redness.

Efficacy of peroral endoscopic myotomy for esophageal motility disorders after gastric surgery: Japan Achalasia Multicenter Study.

OBJECTIVES: Patients with esophageal motility disorders (EMDs) including achalasia after gastric surgery have not been thoroughly characterized. Furthermore, the efficacy of peroral endoscopic myotomy (POEM) in this population should be clarified. METHODS: In this retrospective multicenter study of 3707 patients with EMDs, 31 patients (0.8%) had a history of gastric surgery. Patient characteristics and POEM efficacy were compared between patients with and without previous gastric surgery. RESULTS: In patients with EMD after gastric surgery, age at EMD diagnosis was higher (72.0 years), male sex was predominant (90.3%), and the American Society of Anesthesiologists physical status score was higher (≥II, 48.4%). High-resolution manometry (HRM) findings did not reveal significant differences. In patients who underwent gastric surgery, atrophic gastritis was common (80.6%), and gastric cancer was the primary surgical indication (32.3%). Distal gastrectomy was performed in 28 patients (90.3%). POEM was effective (3.3% adverse events; 100% treatment success). The incidence rates of reflux esophagitis (RE) and symptomatic gastroesophageal reflux disease (GERD) were 60.0% and 16.7%, respectively, without significant intergroup differences, and severe RE was not observed in the long-term follow-up. Extended gastric myotomy was a risk factor for RE. CONCLUSION: Patients with gastric surgery often present severe disease manifestations; the surgical indication is mainly gastric cancer. HRM findings can be similarly used for diagnosis in patients with and without gastric surgery. POEM maintains safety and efficacy with acceptable RE and symptomatic GERD rates. To prevent RE, extended myotomy should be avoided.

Impact of the COVID-19 pandemic on high-resolution manometry and peroral endoscopic myotomy for esophageal motility disorder in Japan.

AIM: To elucidate the impact of the coronavirus disease 2019 (COVID-19) on the practice of high-resolution manometry (HRM) and peroral endoscopic myotomy (POEM) in Japan. METHODS: We utilized a large-scale database involving 14 high-volume centers in Japan to investigate changes in the numbers of HRM and POEM procedures performed and outcomes of POEM between 2019 and 2020. A questionnaire survey was also conducted to analyze pandemic-associated changes in the HRM and POEM protocols. RESULTS: Compared to that in 2019, the number of HRM and POEM procedures decreased by 17.2% (1587-1314) and 20.9% (630-498), respectively. These declines were prominent during the state of emergency from April to May 2020, particularly in pandemic areas. HRM and POEM in nonpandemic areas were relatively unaffected. From 2019 to 2020, there was a 0.4% (254-248) decrease in POEM cases within the prefecture, but the number outside the prefecture decreased by 33.6% (372-247). During the pandemic, the safety and efficacy of POEM were maintained. The implementation of personal protective equipment (PPE) measures varied among facilities, and PPE for POEM was relatively insufficient compared to that for HRM. CONCLUSION: The COVID-19 pandemic influenced HRM and POEM practices in Japan. It is necessary to establish a sufficient system for HRM and POEM in each hospital as well as countrywide to overcome the effects of the pandemic.

Esophageal carcinoma in achalasia patients managed with endoscopic submucosal dissection and peroral endoscopic myotomy: Japan Achalasia Multicenter Study.

OBJECTIVES: Indications for peroral endoscopic myotomy (POEM) and endoscopic submucosal dissection (ESD) in patients with achalasia concomitant with esophageal carcinoma (EC) are unclear. This study aimed to clarify the role of POEM in cases of achalasia concomitant with EC and to elucidate the indications for ESD and efficient surveillance for EC. METHODS: We conducted a multicenter cohort study at 14 hospitals in Japan, including 3707 cases of achalasia-related esophageal motility disorders (EMDs). Factors contributing to EC risk, the characteristics of EC, and clinical outcomes of POEM/ESD were analyzed. RESULTS: In patients undergoing POEM, screening and surveillance endoscopy throughout a 1-year period resulted in diagnosis of 72.1% new EC cases. Of 62 patients with 123 ECs, 40.3% had multiple or metachronous lesions within 37.5 months. EC was predominantly observed in the middle thoracic esophagus (58.5%) and posteriorly (73.2%). POEM had comparable safety and efficacy in cases of concomitant EC even after ESD. Endoscopic en bloc resection was performed in 95.8% and 89.3% of ECs diagnosed before and after POEM, respectively (P = 0.351); however, ESD on the POEM-line was impaired by fibrosis. Multivariate analysis revealed risk factors for EC, including regular alcohol consumption, a history of smoking, advanced age, and extended disease duration. Alcohol intake and smoking had a synergistic effect on EC development. CONCLUSIONS: Screening and surveillance of POEM help in detecting EC. ESD is feasible in achalasia, although on the POEM-line is challenging. Surveillance endoscopy for EC is recommended for cases with specific risks and a history of ECs.

Differences in upper esophageal sphincter function and clinical characteristics among the three subtypes of Japanese patients with esophageal achalasia.

BACKGROUND: The rarity of esophageal achalasia has resulted in little being known about the characteristics of its three subtypes. The upper esophageal sphincter is considered one key factor to prevent aspiration pneumonia, a serious complication of esophageal achalasia. This study aimed to reveal the subtype characteristics of esophageal achalasia and how the upper esophageal sphincter functions and relates to other clinical parameters of the disease. METHODS: We retrospectively investigated the clinical records of patients diagnosed with esophageal achalasia. All participants underwent esophagogastroduodenoscopy and then, within 2 weeks, high-resolution manometry. Gastrointestinal symptoms were assessed using a previously validated self-reported questionnaire. RESULTS: A total of 110 patients with esophageal achalasia were enrolled: 50 with type I, 40 with type II, and 20 with type III. Mean age at diagnosis was 54.5, 50.4, and 66.1 years for types I, II, and III, respectively. Mean resting upper esophageal sphincter pressure was 28.0, 51.8, and 43.6 mmHg for patients with types I, II, and III, respectively (p < 0.01). Patients with type III esophageal achalasia more frequently reported stomachache than those with type I (p = 0.03). A negative correlation between resting upper esophageal sphincter pressure and age was observed in all subtypes. CONCLUSIONS: A negative correlation was confirmed between resting upper esophageal sphincter pressure and age in all subtypes of esophageal achalasia. Type III patients were older at diagnosis, type II patients showed higher upper esophageal sphincter pressure, and type I patients showed a lower upper esophageal sphincter pressure at the early life stage.

Gastric Adenoma: A High Incidence Rate of Developing Carcinoma and Risk of Metachronous Gastric Cancer according to Long-Term Follow-Up.

INTRODUCTION: Gastric adenomas are histologically defined as benign epithelial tumors. While some of them remain adenomas for a long time, others progress to carcinomas. However, long-term outcomes of such cases are not entirely clear. Here, we explored the risk factors and incidence of developing carcinoma from gastric adenoma as well as metachronous gastric cancer. METHODS: This study was conducted at a facility that adopted a follow-up strategy for gastric adenoma. Lesions histologically diagnosed as gastric intestinal-type adenomas between January 2004 and December 2016 were analyzed. Clinicopathological data were collected from patients' medical records, and histological changes from adenoma to carcinoma during endoscopic follow-up and risk factors of cancer development were evaluated. RESULTS: This study involved 409 lesions from 376 patients. The analysis of the development of gastric cancer from adenoma and metachronous gastric cancer was ultimately performed for 282 lesions from 258 patients and 269 lesions from 246 patients, respectively, due to different follow-up periods. The 5-year rate of carcinoma development was 34.0%. Risk factors for carcinoma development upon multivariate analysis were lesion size ≥15 mm and morphological depression. All cases with both factors developed gastric carcinoma, and 50.5% of those with either factor developed carcinoma within 5 years. Gastric adenoma was accompanied by metachronous gastric cancer in 1.5% of the patients annually. The only risk factor for metachronous gastric carcinoma was primary adenoma progressing to carcinoma during the follow-up period. DISCUSSION/CONCLUSION: Given the high rate of carcinoma development in patients with risk factors, resection of gastric adenoma should be considered during the initial examination. Careful observation and follow-up should also be conducted to detect not only changes in the primary adenoma but also the occurrence of metachronous carcinoma, especially in cases of adenoma progressing to carcinoma.

Tolerability and efficacy of the concentration of iodine solution during esophageal chromoendoscopy: a double-blind randomized controlled trial.

BACKGROUND AND AIMS: Esophageal chromoendoscopy with iodine solution is an important diagnostic method for the detection of superficial esophageal cancer. However, the concentration of iodine solution has differed among reports. This study aimed to evaluate patient discomfort with different iodine concentrations. METHODS: We performed a prospective, double-blind, randomized study. We prospectively enrolled and analyzed 77 patients who were at high risk for esophageal carcinoma and scheduled to undergo EGD from March 2018 to January 2019. All patients were divided into 2 groups before the procedure to compare pain measurements: a 1% iodine solution group (group A) and a 2% iodine solution group (group B). The primary endpoint of this study was the difference in pain measurement between 1% and 2% iodine solution chromoendoscopy. Secondary endpoints were safety, detection yield, and color evaluation based on both the endoscopist's survey and color values, as determined using the Commission Internationale de l'Eclairage (CIELAB, Vienna, Austria) color evaluation system, in the iodine-faded and iodine-stained area of each group. RESULTS: Heartburn and retrosternal pain in group A were significantly lower than those in group B (P = .02). Eleven patients reported heartburn and retrosternal pain (group A, 2; group B, 9). Four patients reported pain above the sternal angle and 7 below the sternal angle. There was no significant difference between the 2 groups with regard to detection yield, color evaluation by the endoscopist's assessment, or color values. No patients had any adverse events, and all safely completed this study. CONCLUSIONS: The 2% iodine solution resulted in significantly greater pain than the 1% iodine solution, and the color of the stained esophageal images of each group was the same from this study. Therefore, the 1% iodine solution is recommended for esophageal chromoendoscopy. (Clinical trial registration number: UMIN 000029796.).

Evaluation of the Usefulness and Convenience of the Kyoto Classification of Gastritis in the Endoscopic Diagnosis of the Helicobacter pylori Infection Status.

BACKGROUND/AIMS: The Kyoto Classification of Gastritis was published in 2014. Although this classification is now widely used in Japan, its usefulness and convenience have not been sufficiently evaluated. This study aimed to evaluate the usefulness and convenience of this classification in the endoscopic diagnosis of Helicobacter pylori infection. METHODS: We made a test for the endoscopic diagnosis of H. pylori infection comprising 30 cases who had representative endoscopic features of non-, active, or inactive gastritis. Thirty-eight participants took the test before and after a brief mini-lecture on the Kyoto Classification of Gastritis. Eighteen participants took the test again 3 months later. We investigated the accuracy before, just after, and 3 months after the mini-lecture. RESULTS: The accuracy of endoscopists after the lecture was significantly improved in comparison to before the lecture (77.6 vs. 83.3%). Medical students also showed significantly improved accuracy after the lecture (56.7 vs. 71.7%). Among endoscopists, this improvement was maintained after 3 months. Before the lecture, the accuracy of diagnosing non-gastritis was 90.3%; it tended to be further improved 3 months later (96.5%). A >10% point increase was observed in diagnosing active (72.7-83.3%) and inactive gastritis (73.2-84.3%) at 3 months after the lecture in comparison to before the lecture. CONCLUSION: A brief mini-lecture on the Kyoto Classification of Gastritis improved the accuracy in the endoscopic diagnosis of gastritis, indicating that understanding this classification is useful for the prompt diagnosis of H. pylori infection during esophagogastroduodenoscopy.

Blue laser imaging and linked color imaging improve the color difference value and visibility of colorectal polyps in underwater conditions.

BACKGROUND AND AIM: Underwater endoscopic mucosal resection (UEMR) has become widespread for treating colorectal polyps. However, which observational mode is best suited for determining polyp margins underwater remains unclear. To determine the best mode, we analyzed three imaging modes: white light imaging (WLI), blue laser imaging (BLI) and linked color imaging (LCI). METHODS: Images of consecutive colorectal polyps previously examined by these three modes before UEMR were analyzed according to the degree of underwater turbidity (transparent or cloudy). Color differences between the polyps and their surroundings were calculated using the Commission Internationale d'Eclairage Lab color space in which 3-D color parameters were expressed. Eight evaluators, who were blinded to the histology, scored the visibility from one (undetectable) to four (easily detectable) in both underwater conditions. The color differences and visibility scores were compared. RESULTS: Seventy-three polyps were evaluated. Sixty-one polyps (44 adenomatous, 17 serrated) were observed under transparent conditions, and 12 polyps (seven adenomatous, five serrated) were observed under cloudy conditions. Under transparent conditions, color differences for the BLI (8.5) and LCI (7.9) were significantly higher than that of WLI (5.7; P < 0.001). Visibility scores for BLI (3.6) and LCI (3.4) were also higher than that of WLI (3.1; P < 0.0001). Under cloudy conditions, visibility scores for LCI (2.9) and WLI (2.7) were significantly higher than that of BLI (2.2; P < 0.0001 and P = 0.04, respectively). CONCLUSIONS: BLI and LCI were better observational modes in transparent water; however, BLI was unsuitable for cloudy conditions.

Postoperative bleeding risk after gastric endoscopic submucosal dissection during antithrombotic drug therapy.

BACKGROUND AND AIM: The safety of gastric endoscopic submucosal dissection (ESD) in the antithrombotic drug users remains controversial. METHODS: Patients who underwent gastric ESD at Okayama University Hospital between March 2006 and February 2016 were enrolled. This study investigated the risk of post-ESD bleeding according to the management of the antithrombotic drugs. RESULTS: One thousand twenty lesions (872 patients) were enrolled. In a multivariate analysis, heparin replacement (odds ratio [OR] 5.0, 95% confidence interval [CI] 1.8-14), multiple antithrombotic drug use (OR 2.9, 95% CI 1.1-6.9), a resected specimen of ≥ 33 mm in diameter (OR 2.7, 95% CI 1.5-5.4), Helicobacter pylori negativity (OR 2.2, 95% CI 1.3-3.7), and tumors located in the lower third of the stomach (OR 1.7, 95% CI 1.0-2.9) were significant risk factors for post-ESD bleeding, while the continuation of aspirin or cilostazol was not (OR 2.6, 95% CI 0.72-7.8). The bleeding rate of the continuation group was comparable with that of the all cessation group among single antithrombotic drug users (4.5% vs 4.4%, P = 1.0); however, the rate of the continuation group was significantly higher than that of the all cessation group among multiple antithrombotic drug users (67% vs 15%, P = 0.020). CONCLUSIONS: The risk of post-ESD bleeding differed according to the management of the antithrombotic drugs. The gastric ESD under the cessation or continuation of aspirin or cilostazol monotherapy was acceptable. However, multiple antithrombotic drug use or heparin replacement was associated with a higher risk of post-ESD bleeding.

A Case of Diffuse Esophageal Spasm Treated with Peroral Endoscopic Myotomy.

The indications for peroral endoscopic myotomy (POEM) have been expanded to include diffuse esophageal spasm (DES). A 67-year-old Japanese man presented with a 4-year history of dysphagia. Endoscopy and upper gastrography revealed abnormal peristaltic movements involving interruption of normal peristalsis, and a diverticulum located at the 2 o'clock esophageal position. High-resolution manometry indicated DES. POEM with a long (15 cm) myotomy was performed for the abnormal contractions, which subsequently disappeared along with dysphagia improvement. Our results suggest that esophageal motility disorders accompanying a diverticulum may be eliminated by POEM without treating the diverticulum itself. We speculate that POEM ameliorates esophageal diverticulum by reducing internal esophageal pressure.

The characteristics and outcomes of small bowel adenocarcinoma: a multicentre retrospective observational study.

BACKGROUND: Small bowel adenocarcinoma (SBA) is a rare malignancy that accounts for 1-2% of gastrointestinal tumours. We investigated the clinical characteristics, outcomes, and prognostic factors of primary SBA. METHODS: We retrospectively analysed the characteristics and clinical courses of 205 SBA patients from 11 institutions in Japan between June 2002 and August 2013. RESULTS: The primary tumour was in the duodenum and jejunum/ileum in 149 (72.7%) and 56 (27.3%) patients, respectively. Sixty-four patients (43.0%) with duodenal adenocarcinoma were asymptomatic and most cases were detected by oesophagogastroduodenoscopy (EGD), which was not specifically performed for the detection or surveillance of duodenal tumours. In contrast, 47 patients (83.9%) with jejunoileal carcinoma were symptomatic. The 3-year survival rate for stage 0/I, II, III, and IV cancers was 93.4%, 73.1%, 50.9%, and 15.1%, respectively. Multivariate analysis revealed performance status 3-4, high carcinoembryonic antigen, high lactate dehydrogenase (LDH), low albumin, symptomatic at diagnosis, and stage III/IV disease were independent factors for overall survival (OS). Ten patients (18.5%) with stage IV disease were treated with a combination of resection of primary tumour, local treatment of metastasis, and chemotherapy; this group had a median OS of 36.9 months. CONCLUSIONS: Although most SBA patients were diagnosed with symptomatic, advanced stage disease, some patients with duodenal carcinoma were detected in early stage by EGD. High LDH and symptomatic at diagnosis were identified as novel independent prognostic factors for OS. The prognosis of advanced SBA was poor, but combined modality therapy with local treatment of metastasis might prolong patient survival.

Multicenter Prospective Study on the Safety of Upper Gastrointestinal Endoscopic Procedures in Antithrombotic Drug Users.

BACKGROUND: The Japan Gastroenterological Endoscopy Society updated its guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment in July 2012. However, the safety of endoscopic procedures in antithrombotic drug users has not been fully investigated. AIMS: To evaluate the safety of upper gastrointestinal endoscopic procedures in antithrombotic drug users. METHODS: From September 2013 to September 2015, patients who were taking antithrombotic drugs and who underwent upper gastrointestinal endoscopic procedures were prospectively enrolled at five hospitals. Incidences of bleeding and thrombosis during endoscopic procedures were evaluated. RESULTS: A total of 270 patients [221 for endoscopic mucosal biopsy and 49 for endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) were enrolled. The bleeding rate was 0.9% for endoscopic mucosal biopsy and 22% for EMR/ESD, respectively. The bleeding rate after endoscopic mucosal biopsy was not significantly high, even if antithrombotic drugs were continued (0 vs. 1%, P > 0.99), while it was significantly higher among multiple antithrombotic drug users than single drug users (5.9 vs. 0%, P < 0.05). The bleeding rate after EMR/ESD was also higher among multiple antithrombotic drug users than single drug users, but was not significantly different (33 vs. 14%, P = 0.17). Moreover, there were no differences in bleeding rates according to the cessation or continuance of antithrombotic drugs (20 vs. 25%, P = 0.74). There were no thromboembolisms in all cases. CONCLUSIONS: Upper gastrointestinal endoscopic procedures performed under the new guidelines appear acceptable. However, endoscopic procedures among multiple antithrombotic drug users show a greater potential for bleeding.

Thienopyridine derivatives as risk factors for bleeding following high risk endoscopic treatments: Safe Treatment on Antiplatelets (STRAP) study.

BACKGROUND AND STUDY AIMS: The optimal method of perioperative management of antiplatelet agents during endoscopic procedures that carry a high risk of bleeding is still controversial. The aim of this study was to evaluate the safety of continuing aspirin treatment during these procedures in an Asian population. PATIENTS AND METHODS: A multicenter, prospective, observational cohort study was conducted at six high volume endoscopy centers in Japan. The study included patients at high risk of thromboembolism who were regularly taking antiplatelet agents (e. g. thienopyridine derivatives and aspirin). Enrolled patients continued their aspirin therapy, and underwent endoscopic procedures that had a high risk of bleeding for treatment of lesions in the upper and lower gastrointestinal tracts. The primary end point was the rate of major bleeding complications after endoscopic procedures. RESULTS: The study was terminated in accordance with predetermined safety criteria because 7 of 28 consecutive patients experienced major bleeding complications (25.0 %; 95 % confidence interval 10.7 % - 44.9 %). All major bleeding complications occurred following endoscopic submucosal dissection (ESD; 6 stomach, 1 colon). Univariate analysis showed that postoperative administration of thienopyridine derivatives was the only significant factor associated with postoperative bleeding (P = 0.01). Subanalysis of gastric ESD (23 lesions in 19 patients) confirmed that the administration of thienopyridine derivatives (P = 0.01) and that of multiple agents (P = 0.02) were the significant factors. All bleeding complications (postoperative day 11.2 ±â€Š3.5) occurred after resuming thienopyridine derivative therapy postoperatively (postoperative day 2.3 ±â€Š2.4). CONCLUSION: In Asian patients taking thienopyridine derivatives with aspirin, cautious postoperative care is necessary for those undergoing endoscopic procedures that are associated with a high risk of bleeding, especially gastric ESD. Continuation of aspirin alone during these endoscopic procedures may be acceptable. STUDY REGISTRATION: UMIN000009176.

[A case of renal salt-wasting syndrome during chemotherapy for advanced gastric cancer].

A 66-year-old woman was admitted to our hospital with heartburn and liver dysfunction. She was diagnosed with advanced gastric cancer. After the initiation of chemotherapy with trastuzumab, capecitabine, and cisplatin, she developed hyponatremia and renal failure with renal salt-wasting syndrome (RSWS). She recovered from these conditions after infusion of hypertonic saline. A diagnosis of RSWS should be considered in patients with hyponatremia who receive cisplatin-based chemotherapy.