Associations between Clinicopathological Characteristics and Intraoperative Opioid Requirements during Endoscopic Submucosal Dissection with Monitored Anesthesia Care: A Retrospective Study.

Background and study aims: Endoscopic submucosal dissection is used to treat early gastric neoplasms. Compared with other endoscopic procedures, it requires higher doses of opioids, leading to adverse events during monitored anesthesia care. We investigated the correlations between clinicopathological characteristics and intraprocedural opioid requirements in patients who underwent endoscopic submucosal dissection under monitored anesthesia care. Patients and methods: The medical records of patients who underwent endoscopic submucosal dissection under monitored anesthesia care were retrospectively reviewed. The dependent variable was the total dose of fentanyl administered during the dissection, while independent variables were patient demographics, the American Society of Anesthesiologists physical status classification, preoperative vital sign data, and the pathological characteristics of the neoplasm. Correlations between variables were examined using multiple regression analysis. Results: The study included 743 patients. The median total fentanyl dose was 100 mcg. Younger age (coefficient -1.37; 95% confidence interval [CI] -1.78 to -0.95), male sex (16.12; 95% CI 6.99-25.24), baseline diastolic blood pressure (0.44; 95% CI 0.04-0.85), neoplasm length (1.63; 95% CI 0.90-2.36), and fibrosis (28.59; 95% CI 17.77-39.42) were positively correlated with the total fentanyl dose. Total fentanyl dose was higher in the differentiated (16.37; 95% CI 6.40-26.35) and undifferentiated cancers group (32.53; 95% CI 16.95-48.11) than in the dysplasia group; no significant differences were observed among the others. The mid-anterior wall (22.69; 95% CI 1.25-44.13), mid-posterior wall (29.65; 95% CI 14.39-44.91), mid-greater curvature (28.77; 95% CI 8.56-48.98), and upper groups (30.06; 95% CI 5.01-55.12) had higher total fentanyl doses than the lower group, whereas doses did not significantly differ for the mid-lesser curvature group. Conclusions: We identified variables that influenced opioid requirements during monitored anesthesia care for endoscopic submucosal dissection. These may help predict the needed opioid doses and identify factors affecting intraprocedural opioid requirements.

Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study.

BACKGROUND: Proton-pump inhibitors (PPIs) are the most effective drugs for treating acid-related disorders. However, once-daily dosing with conventional PPIs fail to fully control acid secretion over 24 h. This study aimed to compare the efficacy and safety of HIP1601 (dual delayed-release esomeprazole) and HGP1705 (delayed-release esomeprazole) in patients with erosive esophagitis (EE). METHODS: We enrolled 213 patients with EE randomized in a 1:1 ratio to receive 40 mg HIP1601 (n = 107) or HGP1705 (n = 106) once daily for 4 or 8 weeks. The primary endpoint was the EE healing rate, confirmed by endoscopy up to week 8. GERD-related symptoms and treatment-emergent adverse events were compared between both groups. RESULTS: By week 8, the estimated healing rates of EE were 97.8% and 96.8% in the HIP1601 and HGP1705 groups, respectively, with a 95% confidence interval of -4.7 to 7.2. After 4 or 8 weeks of treatment, the EE healing rate at week 4, complete resolution rate of symptoms, time to sustained resolution of symptoms, and number of rescue medications used were similar in both groups. The proportion of heartburn- and acid regurgitation-free nights by week 4 were higher in the HIP1601 group compared to the HGP1705 group, but the difference did not reach clinical significance (87.7% vs. 85.8%, P = 0.514, 87.5% vs. 85.8%, P = 0.774). The number of adverse events did not differ significantly between the two groups. CONCLUSIONS: The efficacy and safety of HIP1601 40 mg were comparable to those of HGP1705 40 mg for the treatment of EE and symptomatic improvement of GERD. TRIAL REGISTRATION: NCT04080726 ( https://classic. CLINICALTRIALS: gov/ct2/show/NCT04080726 ), registration date: 25/10/2018.

Impact of Coronavirus Disease 2019 on Gastric Cancer Diagnosis and Stage: A Single-Institute Study in South Korea.

PURPOSE: Gastric cancer (GC) is among the most prevalent and fatal cancers worldwide. National cancer screening programs in countries with high incidences of this disease provide medical aid beneficiaries with free-of-charge screening involving upper endoscopy to detect early-stage GC. However, the coronavirus disease 2019 (COVID-19) pandemic has caused major disruptions to routine healthcare access. Thus, this study aimed to assess the impact of COVID-19 on the diagnosis, overall incidence, and stage distribution of GC. MATERIALS AND METHODS: We identified patients in our hospital cancer registry who were diagnosed with GC between January 2018 and December 2021 and compared the cancer stage at diagnosis before and during the COVID-19 pandemic. Subgroup analyses were conducted according to age and sex. The years 2018 and 2019 were defined as the "before COVID" period, and the years 2020 and 2021 as the "during COVID" period. RESULTS: Overall, 10,875 patients were evaluated; 6,535 and 4,340 patients were diagnosed before and during the COVID-19 period, respectively. The number of diagnoses was lower during the COVID-19 pandemic (189 patients/month vs. 264 patients/month) than before it. Notably, the proportion of patients with stages 3 or 4 GC in 2021 was higher among men and patients aged ≥40 years. CONCLUSIONS: During the COVID-19 pandemic, the overall number of GC diagnoses decreased significantly in a single institute. Moreover, GCs were in more advanced stages at the time of diagnosis. Further studies are required to elucidate the relationship between the COVID-19 pandemic and the delay in the detection of GC worldwide.

External Validation of the eCura System for Undifferentiated-Type Early Gastric Cancer with Noncurative Endoscopic Resection.

Background/Aims: The eCura system, a scoring model for stratifying the lymph node metastasis risk after noncurative endoscopic resection for early gastric cancer (EGC), has been internally validated, primarily for differentiated-type EGC. We aimed to externally validate this model for undifferentiated-type EGC. Methods: This multicenter, retrospective cohort study included 634 patients who underwent additional surgery (radical surgery group, n=270) or were followed up without additional treatment (no additional treatment group, n=364) after noncurative endoscopic resection for undifferentiated-type EGC between 2005 and 2015. The lymph node metastasis and survival rates were compared according to the risk categories. Results: For the radical surgery group, the lymph node metastasis rates were 2.6%, 10.9%, and 14.8% for the low-, intermediate-, and high-risk eCura categories, respectively (p for trend=0.003). For the low-, intermediate-, and high-risk categories in the no additional treatment group, the overall survival (92.7%, 68.9%, and 80.0% at 5 years, respectively, p<0.001) and cancer-specific survival rates (99.7%, 94.7%, and 80.0% at 5 years, respectively, p<0.001) differed significantly. In the multivariate analysis, the hazard ratios (95% confidence interval) in the no additional treatment group relative to the radical surgery group were 3.18 (1.41 to 7.17; p=0.005) for overall mortality and 2.60 (0.46 to 14.66; p=0.280) for cancer-specific mortality in the intermediate-to-high risk category. No such differences were noted in the low-risk category. Conclusions: The eCura system can be applied to undifferentiated-type EGC. Close follow-up without additional treatment might be considered for low-risk patients, while additional surgery is recommended for intermediate- and high-risk patients.

Machine Learning Improves the Prediction Rate of Non-Curative Resection of Endoscopic Submucosal Dissection in Patients with Early Gastric Cancer.

Non-curative resection (NCR) of early gastric cancer (EGC) after endoscopic submucosal dissection (ESD) can increase the burden of additional treatment and medical expenses. We aimed to develop a machine-learning (ML)-based NCR prediction model for EGC prior to ESD. We obtained data from 4927 patients with EGC who underwent ESD between January 2006 and February 2020. Ten clinicopathological characteristics were selected using extreme gradient boosting (XGBoost) and were used to develop a ML-based model. Dataset was divided into the training and internal validation sets and verified using an external validation set. Sensitivity, specificity, and area under the receiver operating characteristic curve (AUROC) were evaluated. The performance of each model was compared by using the Delong test. A total of 1100 (22.1%) patients were identified as being treated non-curatively with ESD. Seven ML-based NCR prediction models were developed. The performance of NCR prediction was highest in the XGBoost model (AUROC, 0.851; 95% confidence interval, 0.837-0.864). When we compared the prediction performance by the Delong test, XGBoost (p = 0.02) and support vector machine (p = 0.02) models showed a significantly higher performance among the NCR prediction models. We developed an ML model capable of accurately predicting the NCR of EGC before ESD. This ML model can provide useful information for decision-making regarding the appropriate treatment of EGC before ESD.

A Systematic Review and Meta-analysis of Randomized Control Trials: Combination Treatment With Proton Pump Inhibitor Plus Prokinetic for Gastroesophageal Reflux Disease.

BACKGROUND/AIMS: Prokinetics can be used for treating patients with gastroesophageal reflux disease (GERD), who exhibit suboptimal response to proton pump inhibitor (PPI) treatment. We conducted a systematic review to assess the potential benefits of combination treatment with PPI plus prokinetics in GERD. METHODS: We searched PubMed, the Cochrane Library, and EMBASE for publications regarding randomized controlled trials comparing combination treatment of PPI plus prokinetics to PPI monotherapy with respect to global symptom improvement in GERD (until February 2020). The primary outcome was an absence or global symptom improvement in GERD. Adverse events and quality of life (QoL) scores were evaluated as secondary outcomes using a random effects model. Quality of evidence was rated using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE). RESULTS: This meta-analysis included 16 studies involving 1446 participants (719 in the PPI plus prokinetics group and 727 in the PPI monotherapy group). The PPI plus prokinetics treatment resulted in a significant reduction in global symptoms of GERD regardless of the prokinetic type, refractoriness, and ethnicity. Additionally, treatment with PPI plus prokinetics for at least 4 weeks was found to be more beneficial than PPI monotherapy with respect to global symptom improvement. However, the QoL scores were not improved with PPI plus prokinetics treatment. Adverse events observed in response to PPI plus prokinetics treatment did not differ from those observed with PPI monotherapy. CONCLUSIONS: Combination of prokinetics with PPI treatment is more effective than PPI alone in GERD patients. Further high-quality trials with large sample sizes are needed to verify the effects based on prokinetic type.

Prediction model for bleeding after endoscopic submucosal dissection of gastric neoplasms from a high-volume center.

BACKGROUND AND AIM: Bleeding after endoscopic submucosal dissection (ESD) is a main adverse event. To date, although there have been several studies about risk factors for post-ESD bleeding, there has been few predictive model for post-ESD bleeding with large volume cases. We aimed to design a prediction model for post-ESD bleeding using a classification tree model. METHODS: We analyzed a prospectively established cohort of patients with gastric neoplasms treated with ESD from 2007 to 2016. Baseline characteristics were collected for a total of 5080 patients, and the bleeding risk was estimated using variable statistical methods such as logistic regression, AdaBoost, and random forest. To investigate how bleeding was affected by independent predictors, the classification and regression tree (CART) method was used. The prediction tree developed for the cohort was internally validated. RESULTS: Post-ESD bleeding occurred in 262 of 5080 patients (5.1%). In multivariate logistic regression, ongoing antithrombotic use during the procedure, cancer pathology, and piecemeal resection were significant risk factors for post-ESD bleeding. In the CART model, the decisive variables were ongoing antithrombotic agent use, resected specimen size ≥49 mm, and patient age <62 years. The CART model accuracy was 94.9%, and the cross-validation accuracy was 94.8%. CONCLUSIONS: We developed a simple and easy-to-apply predictive tree model based on three risk factors that could help endoscopists identify patients at a high risk of bleeding. This model will enable clinicians to establish precise management strategies for patients at a high risk of bleeding and to prevent post-ESD bleeding.

Comparison of the Efficacy of Polaprezinc Plus Proton Pump Inhibitor and Rebamipide Plus Proton Pump Inhibitor Treatments for Endoscopic Submucosal Dissection-induced Ulcers.

GOALS: We assessed the efficacy of polaprezinc plus proton pump inhibitor (PPI) treatment for endoscopic submucosal dissection (ESD)-induced ulcer healing compared with rebamipide plus PPI treatment. BACKGROUND: ESD has been widely used as a local treatment option that cures gastric neoplasms. However, it causes large and deep artificial ulcers, and there are no guidelines with regard to the optimal treatment durations and drug regimens for ESD-induced ulcers. Polaprezinc is effective for promoting ulcer healing and helps enhance the quality of ulcer healing. STUDY: Two hundred ten patients with ESD-induced ulcers were randomly allocated to treatment with polaprezinc (150 mg/d) plus pantoprazole (40 mg/d) or treatment with rebamipide (300 mg/d) plus pantoprazole (40 mg/d). We evaluated the ulcer healing rate and condition of the ulcer at 4 weeks after dissection. The χ2 or Fisher exact test and the Student t test were used. RESULTS: The ulcer healing rates at 4 weeks after dissection in the polaprezinc plus pantoprazole treatment group were not inferior compared with those in the rebamipide plus pantoprazole treatment group, both in the intention-to-treat analysis (90.3% and 91.4%, respectively, P=0.523) and per-protocol analysis (89.9% and 91.1%, respectively, P=0.531). The short procedure time was an independent predictive factor for a high ulcer healing rate (odds ratio: 0.975; 95% confidence interval: 0.958-0.993; P=0.006). CONCLUSION: The polaprezinc plus PPI treatment showed noninferiority to rebamipide plus PPI treatment in the ulcer healing rate at 4 weeks after ESD.

Long-Term Outcomes and Prognostic Factors of Superficial Esophageal Cancer in Patients Aged ≥ 65 Years.

BACKGROUND: The number of elderly patients with superficial esophageal cancer (SEC) is increasing. We aimed to evaluate the clinical outcomes and prognostic factors of overall survival (OS) in elderly patients undergoing endoscopic submucosal dissection (ESD) or surgical resection for SEC. METHODS: Between January 2001 and May 2020, 290 patients aged ≥65 years who underwent ESD or surgical resection for SEC were evaluated. Their clinical outcomes and prognosis were assessed, and independent risk factors for OS were identified. RESULTS: The mean patient age (269 men and 21 women) was 70.9 years (range 65-90 years). En bloc, R0, and curative resections were achieved in 94.5%, 90.0%, and 73.4% of the patients, respectively. During the follow-up [mean: 54.6 months (range: 1-210 months)], 79 patients died. The 3-, 5-, and 10-year OS rates were 82.5, 73.1, and 59.7%, respectively. In multivariate analysis, cancer history of the other organs, American Society of Anesthesiologists performance status, and presence of lymphovascular involvement (hazard ratio = 1.852, 1.656, and 1.943, respectively; all P < 0.05) were independent risk factors for poor OS. The high-risk group (≥2 risk factors) showed a significantly lower OS than the low-risk group (≤ 1 risk factor) (P < 0.001). CONCLUSIONS: The three risk factors could be useful in predicting the long-term prognosis of elderly patients with SEC.

Long-Term Outcomes and Prognostic Factors of Endoscopic Submucosal Dissection for Early Gastric Cancer in Patients Aged ≥75 Years.

BACKGROUND AND AIMS: The number of elderly patients with early gastric cancer (EGC) who meet the indications for endoscopic submucosal dissection (ESD) is increasing. We aimed to evaluate the clinical outcomes and prognostic factors of overall survival (OS) in elderly patients undergoing ESD for EGC. METHODS: Between January 2006 and December 2018, 439 patients aged ≥75 years who underwent ESD for EGC were analyzed. The clinical outcomes and prognosis were evaluated, and independent risk factors for OS were identified. RESULTS: The mean patient (302 men, 137 women) age was 78.3 (range 75-92) years. En bloc, R0, and curative resections were achieved in 96.8%, 90.7%, and 75.6%, respectively, without severe adverse events. During the follow-up (median 54.2 (range 4.0-159.6) months), 86 patients died (three of gastric cancer). The 3-, 5-, and 10-year OS was 91.2%, 83.5%, and 54.5%, respectively, and the 3-, 5-, and 10-year cancer related survival rate were 99.7%, 99.1% and 97.5%, respectively. In multivariate analysis, smoking, history of cancer of other organs, NLR > 1.6, Charlson comorbidity index ≥ 3, and presence of lymphovascular invasion (hazard ratio = 3.96, 1.78, 1.83, 1.83, and 2.63, respectively, all p < 0.05) were independent five risk factors for poor OS. The high-risk group (≥3 risk factors) showed a significantly lower OS than the low-risk group (<2 risk factors) (p < 0.001). CONCLUSIONS: The five factors could be useful in predicting the long-term prognosis of elderly ESD patients or deciding the therapeutic approaches in case of non-curative resection.

Efficacy of Endoscopic Vacuum-Assisted Closure Treatment for Postoperative Anastomotic Leak in Gastric Cancer.

Background/Aims: Endoscopic vacuum-assisted closure (EVAC) has been attempted as new nonsurgical treatment for anastomotic leakage. We aimed to evaluate the clinical outcomes of EVAC and compare its efficacy with the self-expandable metallic stent (SEMS) for postgastrectomy leakage. Methods: Between January 2007 and February 2018, 39 patients underwent endoscopic treatment for anastomotic leakage after gastric cancer surgery. Of them, 28 patients were treated with SEMS, seven with EVAC after SEMS failure, and four with EVAC. We retrospectively compared the clinical characteristics and therapeutic outcomes between EVAC (n=11) and SEMS (n=28). Results: The median followup duration was 17 months (interquartile range, 9 to 26 months) in both groups. In comparison of clinical characteristics between two groups, only the median size of the leak was larger in the EVAC group than in the SEMS group (2.1 cm vs 1.0 cm; p<0.001). All EVAC cases healed successfully; however, two cases (7.1%) failed to heal in the SEMS group. Anastomotic stricture occurred one case (9.1%) in EVAC and four cases (14.3%) in SEMS within 1 year after endoscopic treatment. The median treatment duration of EVAC was shorter than that of SEMS (15 days vs 36 days; p<0.001). Median weight loss after therapy was similar in both groups (8.0 kg in EVAC vs 9.0 kg in SEMS; p=0.356). Conclusions: EVAC can be effective endoscopic treatment for postgastrectomy anastomotic leakage. Substantial leakage could be an important clinical factor for considering EVAC as a treatment option. Large randomized controlled trials are needed to confirm the efficacy of EVAC.

A potential simple endoscopic antireflux method, "the Ripple Procedure" to reduce distensibility at the esophagogastric junction in a porcine model.

BACKGROUND AND AIMS: Currently available endoscopic or minimally invasive antireflux modalities are not widely accepted due to high procedure cost or inconsistent results. Therefore, a simpler and less technically demanding method is required. We evaluated the feasibility and efficacy of new endoscopic antireflux method (the Ripple Procedure) using functional lumen imaging probe (FLIP). METHODS: This 5-week survival study included 10 domestic pigs (control, n = 4; experimental [Ripple], n = 6). The procedure includes the following steps: (i) semicircular marking along the lesser curvature of the cardia; (ii) submucosal injection; and (iii) semicircular mucosal incision along the marking. Endoscopic and FLIP evaluations were performed preoperatively and on postoperative days (PODs) 14 and 35. Technical feasibility was evaluated, and FLIP parameters, including the distensibility index (DI) at the esophagogastric junction (EGJ) and histopathological findings, were compared between groups. RESULTS: The median procedure time was 28 (23.5-33.8) min. There was no significant difference in dysphagia score and body weight between groups. On POD 35, the Ripple group showed significantly lower EGJ DI at 30 mL [2.0 (1.3-2.5) vs 4.9 (2.7-5.0), P = 0.037]. The EGJ DI was significantly reduced at 30 mL, compared with that at the baseline level [- 59.0% (- 68.8% to - 32.1%) vs 27.8% (- 26.3% to 83.1%), P = 0.033]. Histologic evaluation revealed submucosal granulation tissues near the mucosal incision site, with increased intervening fibrosis between lower esophageal sphincter fibers in the Ripple group. CONCLUSION: The EGJ DI significantly decreased after the Ripple Procedure; hence, the procedure appears to be feasible and effective in this porcine model.

High CD3 and ICOS and low TIM-3 expression predict favourable survival in resected oesophageal squamous cell carcinoma.

With the increasing oncological potential of immunotherapy, several immune checkpoint modulators are being investigated. The value of immune markers, including programmed cell death ligand-1, programmed cell death-1 (PD-1), inducible co-stimulator (ICOS), lymphocyte activation gene-3, T-cell immunoglobulin, and mucin-dominant containing-3 (TIM-3), is not well known. Using tissue microarrays of 396 patients who underwent surgery for oesophageal squamous cell carcinoma (ESCC), infiltrated T-cell subsets (CD3, CD8, and Foxp3) and checkpoint protein expression were scored. With a median follow-up of 24.8 months, CD3+ TIL subsets (50.0%) had longer median recurrence-free survival (RFS, 55.0 vs 21.4 months) and overall survival (OS, 77.7 vs 35.8 months). Patients with high ICOS expression (46.5%) had longer median RFS (53.9 vs 25.3 months) and OS (88.8 vs 36.9 months). For PD-1, RFS (hazard ratio [HR] 0.67) and OS (HR 0.66) were significantly longer in the high-expression group (45.2%). In the multivariate analysis, high TIM-3 expression (50.8%) had a significant relationship with shorter RFS (HR = 1.52) and OS (HR = 1.60). High CD3+ TIL and T-cell ICOS expression were associated with favourable prognosis, whereas high TIM-3 expression suggested a poor prognosis. Our findings may confer new insights to improve ESCC outcomes beyond the application of PD-1 blockade.

Phase II trial of preoperative sequential chemotherapy followed by chemoradiotherapy for high-risk gastric cancer.

BACKGROUND AND PURPOSE: To evaluate the safety and efficacy of preoperative chemotherapy (CTx) followed by chemoradiotherapy (CCRT) for high-risk gastric cancer (GC). METHODS AND MATERIALS: The inclusion criteria were as follows: (1) Borrmann type 4; (2) large Borrmann type 3 (≥8 cm); (3) single bulky (≥3 cm × 1) or multiple lymph nodes (≥1.5 cm × 3). Patients received two 21-day courses of induction CTx of TS-1 (35 mg/m2, p.o, twice daily on days 1-14), docetaxel (30 mg/m2, i.v., days 1 and 8), and cisplatin (30 mg/m2, i.v., days 1 and 8) followed by CCRT (two courses of TS-1 and cisplatin in combination with 45 Gy radiation). RESULTS: Forty-two patients were enrolled between March 2014 and February 2016, and 39 of these completed sequential CTx and CCRT. Among the 33 patients who underwent R0 resection, the pathologic response rate was 39.4% [no residual carcinoma (n = 5, 15.2%), with 1-10% residual carcinoma (n = 8, 24.2%)]. Overall, 4 patients (12.1%) were pathologic stage 0, 7 (21.2%) were stage I, 10 (30.3%) were stage II, and 12 (36.4%) were stage III. The overall survival rate at 3 years was 77.9% for stages 0 and I, 66.8% for stages II-III, and 33.3% for unresectable cases (P = 0.001). Toxicity was mild to moderate with grade 4 neutropenia (n = 1) and neutropenic fever (n = 1) as the most prominent side-effects. CONCLUSIONS: Sequential CTx and CCRT prior to surgery are feasible and effective for high-risk GC. TRIAL REGISTRATION NUMBER: NCT02495493.

The Clinical Efficacy of a Pure Alginate Formulation (Lamina G) for Controlling Symptoms in Individuals with Reflux Symptoms: A Randomized Clinical Study.

Background/Aims: Bicarbonate-containing alginate formulations are reported to be effective for controlling reflux symptoms. However, the efficacy of Lamina G alginate without gas production has not been reported. The aim is to evaluate the efficacy of a non-bicarbonate alginate in individuals with reflux symptoms without reflux esophagitis. Methods: Participants who had experienced heartburn or regurgitation for 7 consecutive days were randomized to one of the following treatment groups: proton pump inhibitors (PPI) plus alginate (combination) or PPI plus placebo (PPI only). In addition, as a reference group, patients received placebo plus alginate (alginate only). The primary endpoint compared the percentage of patients with complete resolution of symptoms for the final 7 days of the treatment. Secondary endpoints compared changes in symptom score, symptom-free days during the treatment period, the Reflux Disease Questionnaire, Patient Assessment of Upper Gastrointestinal Disorders (PAGI)-Quality of Life and PAGI-Symptoms Severity Index scores, the investigator's assessment of symptoms, and incidence of adverse events. Results: Complete resolution of heartburn or regurgitation was not significantly different between the combination and PPI only groups (58.7% vs 57.5%, p=0.903). The secondary endpoints were not significantly different between the two groups. Complete resolution of heartburn or regurgitation, did not differ between the alginate only reference group and the PPI only group (75.0% vs 57.5%, p=0.146). Conclusions: The addition of non-bicarbonate alginate to PPI was no more effective than PPI alone in controlling reflux symptoms.

Prospective comparative study of endoscopic ultrasonography-guided fine-needle biopsy and unroofing biopsy.

BACKGROUND AND AIM: Adequate tissue acquisition is important in making treatment decisions for patients with upper gastrointestinal subepithelial tumors (SETs). This study aimed to compare the outcomes of endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB) with those of the unroofing biopsy technique. METHODS: This study was a single-center, prospective comparative study conducted at Severance Hospital, Yonsei University College of Medicine. A total of 39 patients with SETs ≥15 mm were enrolled between January 2016 and August 2017. RESULTS: Of the 39 patients, 28 underwent biopsy with both techniques (4 underwent only unroofing and 7 underwent only EUS-FNB). Histological diagnosis was made with EUS-FNB in 64.3% and unroofing biopsy in 78.6% (p = 0.344), and immunohistochemical diagnosis was made with EUS-FNB in 46.4% and unroofing biopsy in 67.9% (p = 0.180). In the subgroup analysis (28 patients), there was no significant difference in diagnostic yield between the 2 methods The mean procedural time with EUS-FNB was shorter than that with unroofing biopsy (p < 0.001). The larger SET (≥ 20 mm) (p = 0.035) and satisfaction of procedure (p = 0.019) were positively associated with successful histological diagnosis by EUS-FNB. CONCLUSIONS: There was no significant difference in the histological diagnostic yield for SETs between the EUS-FNB and unroofing biopsy techniques (CinicalTrials.gov. identifier NCT02646241).

Noninvasive prediction model for diagnosing gastrointestinal stromal tumors using contrast-enhanced harmonic endoscopic ultrasound.

BACKGROUND & AIMS: Subepithelial tumors (SETs) are difficult to diagnose accurately without invasive pathological confirmation. We created a noninvasive prediction model for diagnosing gastrointestinal stromal tumors (GISTs) using contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS). METHODS: We retrospectively reviewed 176 patients who underwent CEH-EUS from October 2011 to August 2017. Seventy patients with a diagnosis of GIST (n = 37) or leiomyoma (n = 33) were included. The long-to-short axis ratio (LSR) and enhancement patterns (vascularity, diffuse enhancement) on CEH-EUS were assessed. Logistic regression and classification and regression tree (CART) analyses were performed. RESULTS: The mean age of all patients was 54.9 ±â€¯13.68 years. The GIST group showed significantly higher rates of positive vascularity (81.1% vs. 15.2%, p < 0.001) and diffuse enhancement (51.4% vs. 15.2%, p = 0.001), and lower LSR (1.30 vs. 1.76, p < 0.001). In multivariate logistic regression, positive vascularity (odds ratio [OR] 27.765, 95% confidence interval [CI] 5.336-144.458) and low LSR (OR 18.940, 95% CI 3.623-99.007) were independent predictors of GIST. A noninvasive prediction model for GISTs was developed using the CART model, by allocating patients according to statistically significant variables. CONCLUSIONS: The LSR and vascularity of SETs on CEH-EUS can be used as parameters for a noninvasive prediction model of GISTs. This model may be helpful in the early identification and treatment of GISTs.

Hemostatic powder application for control of acute upper gastrointestinal bleeding in patients with gastric malignancy.

BACKGROUND AND STUDY AIMS: Despite use of various endoscopic therapies in patients with tumor-related bleeding, various rates of successful immediate hemostasis and short-term rebleeding have been reported. We aimed to evaluate preliminary results of use of the EndoClot polysaccharide hemostatic system (PHS) in patients with acute upper gastrointestinal bleeding (UGIB) from a gastric malignancy. PATIENTS AND METHODS: We retrospectively analyzed data from a prospectively collected database of 12 patients with acute UGIB from a gastric malignancy who had been treated with EndoClot PHS. The EndoClot air compressor was used to propel 2 g of absorbable modified polymer particles onto the bleeding site. We checked successful immediate hemostasis, rebleeding events and mortality within 30 days. RESULTS: Twelve patients were enrolled in the study. The median patient age was 72.5 years (range, 57 - 89). The initial median hemoglobin level was 6.75 g/dL (range, 5.4 - 8.9). The median systolic blood pressure was 114 mmHg (range, 86 - 153). Eleven patients had advanced gastric cancer and one patient had a gastrointestinal stromal tumor. The lower body of the stomach was the most common tumor location (58.3 %), and the median tumor size was 40 mm (range, 15 - 100). Immediate hemostasis was achieved in all patients, and rebleeding developed in 2 of 12 patients (16 %), 3 and 5 days after treatment. There were no significant Endoclot PHS-related adverse events, and there was no all-cause mortality at 30 days after the intervention. CONCLUSIONS: Endoclot PHS represents a new alternative, complementary, and promising therapy for patients with an acute UGIB from a gastric malignancy.

Comparison of long-term clinical outcomes between endoscopic and surgical resection for early-stage adenocarcinoma of the esophagogastric junction.

BACKGROUND: The aim of this study was to analyze long-term clinical and oncologic outcomes in patients with early-stage adenocarcinoma of the esophagogastric junction (AEG) managed with either endoscopic resection (ER) or surgery. METHODS: The inclusion criteria were AEG, meeting classic or expanded indications for ER of early gastric cancer, and complete resection. A total of 66 patients with Siewert type II AEG were included (ER group, n = 38; vs. surgery group, n = 28). RESULTS: The mean age of the ER group was greater than that of the surgery group (mean ± SD, 66.9 ± 9.7 vs. 58.5 ± 10.4 years, respectively; p = 0.001). Compared to the ER group, macroscopically flat or depressed-type lesions were more common (47.4 vs. 89.3%; p = 0.001), and mean lesion size was larger in the surgery group (13.3 ± 8.4 vs. 18.6 ± 11.0 mm; p = 0.039). One intensive care unit admission and subsequent surgery-related death occurred in the surgery group (1/28 vs. 0/38 in the ER group; p = 0.424). During follow-up, recurrence was detected in both groups (4/38 vs. 1/28; p = 0.385). Overall survival and 5-year disease-free survival did not differ between the groups (93.3 vs. 92.9%; p = 0.282 and 88.0 vs. 100.0%; p = 0.066). CONCLUSIONS: Once complete resection is achieved in patients with AEG who met the expanded criteria for endoscopic submucosal dissection of gastric cancer, there was no significant difference in clinical outcomes between ER and surgery.