The effect of biological agent on body composition in patients with Crohn's disease.

BACKGROUND: Crohn's disease (CD) is associated with altered body composition, affecting clinical outcomes. We evaluated the impact of biologics on body composition in CD patients. METHODS: This multicenter longitudinal study across four Korean university hospitals conducted from January 2009 to August 2021 retrospectively reviewed data of CD patients with abdominal computed tomography (CT) before and after the biologic treatment. Skeletal muscle area (SMA), visceral fat area (VFA), and subcutaneous fat area (SFA) of the third lumbar vertebra (L3) on CT were measured. Myopenia was defined as L3 skeletal muscle index (SMI) of < 49 and < 31 cm2/m2 for men and women, respectively. RESULTS: Among 112 participants, 79 (70.5%) had myopenia. In the myopenia group, all body composition parameters were significantly increased after the biologic treatment: SMI (37.68 vs. 39.40 cm2/m2; P < 0.001), VFA (26.12 vs. 54.61 cm2; P < 0.001), SFA (44.29 vs. 82.42 cm2; P < 0.001), while no significant differences were observed in the non-myopenia group. In multivariate analysis, penetrating CD (hazard ratio, 5.40; P = 0.020) was the independent prognostic factor for surgery. Operation-free survival rate tended to decrease in the myopenia group (Log-rank test, P = 0.090). CONCLUSIONS: Biological agents can increase all body composition parameters in CD patients with myopenia. These patients are more likely to experience surgery.

Incidence and adverse clinical events of primary sclerosing cholangitis with ulcerative colitis.

PURPOSE: The aim of this study was to conduct a nationwide population-based study to estimate the incidence of primary sclerosing cholangitis in patients with ulcerative colitis (UC-PSC) and investigate healthcare use, medication use, surgery, cancer, and death as adverse clinical events of UC-PSC. METHODS: We identified incident cases of UC with (UC-PSC) or without PSC (UC-alone) between 2008 and 2018 using health insurance claims data in Korea. Univariate (crude hazard ratio (HR)) and multivariate analyses were performed to compare the risk of adverse clinical events between groups. RESULTS: A total of 14,406 patients with UC using population-based claims data were detected in the cohort. Overall, 3.38% (487/14,406) of patients developed UC-PSC. During a mean follow-up duration of approximately 5.92 years, the incidence of PSC in patients with UC was 185 per 100,000 person-years. The UC-PSC group showed statistically more frequent healthcare use (hospitalization and emergency department visits: HRs, 5.986 and 9.302, respectively; P < .001), higher immunomodulator and biologic use (azathioprine, infliximab, and adalimumab: HRs, 2.061, 3.457, and 3.170, respectively; P < .001), and higher surgery rate (operation for intestinal obstruction, and colectomy: HRs, 9.728 and 2.940, respectively; P < .001) than did the UC-alone group. The UC-PSC group also showed significantly higher colorectal cancer and biliary tract cancer (HRs, 2.799 and 36.343, respectively; P < .001) and mortality (HR, 4.257) rates than did the UC-alone group. CONCLUSION: Patients with UC-PSC have higher risks of colorectal cancer, biliary tract cancer, and death than do patients with UC-alone. Although considered a rare disease, managing this complex and costly disease requires recognition of the impact of increased burden on healthcare services.

Longitudinal trends in direct costs and healthcare utilization ascribable to inflammatory bowel disease in the biologic era: a nationwide, population-based study.

BACKGROUND AND AIM: Biologic-era data regarding the direct cost and healthcare utilization of inflammatory bowel disease at the population level are limited, especially in Asia. Thus, we aimed to investigate the nationwide prevalence, direct cost, and healthcare utilization of inflammatory bowel disease in Korea in a recent 10-year period. METHODS: Using the Korean National Health Insurance claim data from 2008 to 2017, we investigated all prescription medications and their associated direct costs, hospitalizations, and outpatient visits. We also estimated the nationwide prevalence of inflammatory bowel disease using population census data. RESULTS: The estimated inflammatory bowel disease prevalence significantly increased from 108.8/100 000 in 2008 to 140.4/100 000 in 2017. The overall annual costs for inflammatory bowel disease and the healthcare cost per capita increased from $24.5 million (in US dollars) to $105.1 million and from $458.4 to $1456.6 million, respectively (both P < 0.001). Whereas the ratio of outpatient costs increased from 35.3% to 69.4%, that of outpatient days remained steady. The total annual medication cost and proportion rose from $13.3 million to $76.8 million and from 54.2% to 73.3%, respectively, mainly due to the increasing antitumor necrosis factor cost, from $1.5 million to $49.3 million (from 11.1% to 64.1% of the total annual drug cost and from 6.3% to 46.9% of the total annual cost). CONCLUSIONS: We observed increasing trends in the prevalence, direct costs, and healthcare utilization of inflammatory bowel disease in Korea in recent years. The attributable cost was mainly driven by rising expenditures on antitumor necrosis factor medications.

Feasibility of endoscopic resection and impact of endoscopic ultrasound-based surveillance on colorectal subepithelial tumors.

BACKGROUND: Owing to the rising number of screening endoscopies and instrumental advances in endoscopic ultrasound (EUS), colorectal subepithelial tumors (SETs) are being increasingly detected. We aimed to determine the feasibility of endoscopic resection (ER) and the impact of EUS-based surveillance on colorectal SETs. METHODS: The medical records of 984 patients with incidentally detected colorectal SETs between 2010 and 2019 were retrospectively reviewed. Overall, 577 colorectal SETs underwent ER, and 71 colorectal SETs underwent serial colonoscopy for > 12 months. RESULTS: The mean tumor size (± standard deviation) of 577 colorectal SETs for which ER was performed was 7.0 ± 5.7 (median, 55; range, 1-50) mm; 475 tumors were located in the rectum and 102, in the colon. En bloc resection was achieved in 560/577 treated lesions (97.1%), and complete resection was achieved in 516/577 (89.4%). ER-related adverse events occurred in 15/577 (2.6%) patients. SETs originating from the muscularis propria showed a higher risk of ER-related adverse events and perforation than SETs arising from the mucosal or submucosal layer (odds ratio [OR] 19.786, 95% confidence interval [CI] 4.556-85.919; P = 0.002 and OR 141.250, 95% CI 11.596-1720.492; P = 0.046, respectively). Seventy-one patients were followed up after EUS without any treatment for > 12 months, during which three showed progression; eight, regression; and sixty, no changes. CONCLUSIONS: ER for colorectal SETs showed excellent efficacy and safety. Additionally, colorectal SETs without high-risk features in surveillance with colonoscopy showed an excellent prognosis.

Clinical outcomes and risk factors associated with poor prognosis after endoscopic resection of 10-20 mm rectal neuroendocrine tumors: a multicenter, retrospective study of 10-year experience.

BACKGROUND: The efficacy of endoscopic resection for of 10-20 mm rectal neuroendocrine tumor (NET) remains controversial. We aimed to evaluate the clinical outcomes and risk factors associated with poor prognosis after endoscopic resection of 10-20 mm rectal NET and to determine the optimal treatment. METHODS: Patients who underwent endoscopic resection for rectal NET in four tertiary hospitals were enrolled, and data on with the clinical outcomes and risk factors related to poor prognosis were retrospectively analyzed. RESULTS: A total of 105 patients who underwent endoscopic submucosal resection (ESD; n = 65, 61.9%), modified endoscopic mucosal resection (mEMR; n = 31, 29.5%), and conventional EMR (cEMR; n = 9, 8.6%) were enrolled. The mean follow-up period was 41.2 ± 21.9 months. In the morphologic findings, the mean diameter was 11.6 mm (range 10-19); the shape was sessile (50.5%) and mixed type (49.5%), and surface depression was observed in 41.9% of patients. In the histologic findings, 87.6% of patients had G1 and 12.4% G2 tumor grade, and 3.8% of patients had lymphovascular invasion. The overall en bloc and histologically complete (R0) resections were 99.1% and 76.2%, respectively. cEMR was a less-frequently developed R0 resection. In the univariate and multivariate analyses for R0 resection, only surface depression was significantly associated. Regional or distant organs metastasis during follow-up developed in three patients (2.9%) and was significantly associated with female sex, redness, G2 tumor grade, and non-ESD methods. CONCLUSION: Patients who underwent endoscopic resection of 10-20 mm rectal NET had good prognosis; therefore, endoscopic resection can be considered as the first-line treatment, particularly for 10-14 mm rectal NET. However, the risk factors, such as female sex, redness, G2 tumor grade and non-ESD methods, were associated with regional or distant metastases during follow-up. Therefore, patients with these risk factors should be carefully monitored.

Diagnostic performance of endoscopic ultrasonography-guided fine-needle biopsy in upper gastrointestinal subepithelial tumors measuring 2-5 cm in size.

BACKGROUND: Subepithelial tumors (SETs) in the upper gastrointestinal (GI) tract are frequently discovered during upper endoscopy, and their management is determined based on size and histopathological diagnosis. We aimed to evaluate the diagnostic performance of endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB) in upper GI SETs of 2-5 cm in size. METHODS: We included 63 patients who underwent EUS-FNB for upper GI SETs of 2-5 cm in size between January 2013 and February 2020. The diagnostic yield of EUS-FNB, ability of EUS-FNB in discriminating malignant from non-malignant lesions, and histopathological concordance between EUS-FNB specimens and resected specimens were evaluated. RESULTS: Successful acquisition of macroscopic tissue cores was possible in all 63 cases, and the diagnostic yield of EUS-FNB was 92.1% (58/63). The sensitivity, specificity, and accuracy of EUS-FNB in discriminating malignant from non-malignant lesions were 100% (95% confidence interval [CI] 85.3-100%), 87.8% (95% CI 79.9-87.8%), and 92.1% (95% CI 81.8-92.1%), respectively. Of the 26 SETs that were endoscopically or surgically resected after EUS-FNB, the histopathological concordance rate between the EUS-FNB specimens and resected specimens was 100% (24/24), except in two cases of inadequate results with EUS-FNB specimens. CONCLUSION: EUS-FNB provides high diagnostic yield and high capability in discriminating malignant from non-malignant lesions in upper GI SETs of 2-5 cm in size.

Association between mucin phenotype and lesion border detection using acetic acid-indigo carmine chromoendoscopy in early gastric cancers.

BACKGROUND: For successful treatment of early gastric cancers (EGCs), it is crucial to define the horizontal border of the lesion with high accuracy. Acetic acid-indigo carmine (AI) chromoendoscopy has been used to determine the horizontal border in EGCs, but this technique is less potent in certain situations. Mucin phenotype in gastric cancers refers to biological differences in precursor lesions and differences in histopathologic findings, and it might affect AI chromoendoscopy findings. We aimed to investigate the association between mucin phenotype and AI chromoendoscopy findings in EGCs. METHODS: We prospectively evaluated 126 lesions in 126 patients with endoscopically diagnosed EGCs. Conventional endoscopy and AI chromoendoscopy findings of these lesions before treatment were prospectively analyzed. The border distinction between the lesion and surrounding mucosa was classified as distinct or indistinct on conventional endoscopy and AI chromoendoscopy, respectively. Mucin phenotypes were classified as gastric, intestinal, gastrointestinal, or null type by immunohistochemistry. RESULTS: The lesion borders were distinct in 46.8% (59/126) of the lesions assessed using conventional endoscopy and in 73.0% (92/126) of those assessed with AI chromoendoscopy (p < 0.001). The border distinction rate of differentiated-type cancers on AI chromoendoscopy was significantly higher than that on conventional endoscopy (66/71 [93.0%] vs. 34/71 [47.9%], p < 0.001), but the border distinction rate of undifferentiated-type cancers on AI chromoendoscopy was not different from that on conventional endoscopy (26/55 [47.3%] vs. 25/55 [45.5%], p = 0.848). Compared with conventional endoscopy, AI chromoendoscopy identified borders in a significantly higher percentage of gastric, intestinal, and gastrointestinal mucin types; however, there was no difference in AI chromoendoscopy findings according to the mucin phenotype (p = 0.271). CONCLUSION: AI chromoendoscopy was effective in horizontal border delineation in differentiated-type EGCs, but not in undifferentiated-type EGCs. Mucin phenotype had no effect on border distinction using AI chromoendoscopy.

Long-term outcomes of endoscopically resected laterally spreading tumors with a positive histological lateral margin.

BACKGROUND: With advances in diagnostic endoscopy, the incidence of superficial colorectal tumors, including laterally spreading tumors (LSTs), has increased. However, little is known about the long-term results of LSTs with positive lateral margin after endoscopic treatment. This study aimed to evaluate the long-term clinical outcomes and risk factors for local recurrence of LSTs with positive lateral margin after initial endoscopic resection. METHODS: We performed a retrospective analysis of the medical records of 324 patients who had 363 LSTs with positive lateral margin after endoscopic resection at a tertiary academic medical center. The medical records from 2011 to 2015 were analyzed. Local recurrence was confirmed through endoscopic finding and subsequent biopsy analysis. We assessed the local recurrence rate and performed multivariate analyses to identify the factors associated with local recurrence. RESULTS: Follow-up colonoscopy was performed in 176 of 363 LSTs. The local recurrence rate was 6.3% (11/176), with a median (interquartile range [IQR]) follow-up period of 19.8 (12.4-46.5) months. In multivariate analysis, local recurrence was associated with piecemeal resection (odds ratio [OR] 6.62, 95% confidence interval [CI] 1.28-34.33; p = 0.024) and inversely associated with thermal ablation (OR 0.033, 95% CI 0.00-0.45; p = 0.011). At surveillance colonoscopy, histology of the recurrent tumor was adenoma in 10 (90.9%) of 11; these were treated endoscopically. CONCLUSIONS: In this retrospective study, we found that endoscopically resected LSTs with positive lateral margin have a low recurrence rate. Piecemeal resection was associated with higher local recurrence, and thermal ablation was inversely associated with local recurrence. Endoscopic resection with positive lateral margin combined with thermal ablation leads to a low recurrence rate.

Histopathologic discrepancies between endoscopic forceps biopsy and endoscopic resection specimens in superficial esophageal squamous neoplasms.

BACKGROUND AND AIM: Endoscopic forceps biopsy results that reflect the final pathologic results of an entire lesion are essential for making accurate diagnoses and appropriate therapeutic decisions for patients with superficial esophageal squamous neoplasms (SESNs). This study investigated the histopathologic discrepancies between endoscopic forceps biopsy and endoscopic resection specimens to elucidate the factors contributing to such discrepancies. METHODS: This retrospective observational study involved 77 patients (84 lesions) who underwent endoscopic resections for SESNs, between January 2005 and August 2017, at the Pusan National University Hospital. The SESNs were classified as low-grade intraepithelial neoplasms (LGINs), high-grade intraepithelial neoplasms (HGINs), or squamous cell carcinomas (SCCs). Following slide reviews, the histopathologic concordance between endoscopic forceps biopsy and endoscopic resection specimens was assessed, in each case. RESULTS: The histopathologic discrepancy rate between the endoscopic forceps biopsy and endoscopic resection specimens was 34.5% (29/84 lesions). Among the 29 diagnostically discordant lesions, upgrades and downgrades of the histopathologic diagnoses occurred for 27 and 2 lesions, respectively. The predominant discrepancies results in lesion upgrades from HGIN to SCC (n = 21) and from LGIN to SCC (n = 5). The two downgraded cases included one from SCC to HGIN and one from HGIN to LGIN. Multivariate analyses identified two factors that were significantly associated with the histopathologic discrepancies: upper esophageal location (odds ratio, 7.743; 95% confidence interval, 1.031-58.174; P = 0.047) and tumor area per biopsy ≥ 158.6 mm2 /biopsy (odds ratio, 5.933; 95% confidence interval, 1.051-44.483; P = 0.044). CONCLUSION: Histopathologic discrepancies were observed between endoscopic forceps biopsy and endoscopic resection specimens in patients with SESNs. Tumor location and tumor area/biopsy were both significantly associated with the discrepancies.

Long-term outcome of endoscopic submucosal dissection is comparable to that of surgery for early gastric cancer: a propensity-matched analysis.

BACKGROUND: Data concerning the long-term outcomes of endoscopic submucosal dissection (ESD) versus surgery for early gastric cancer (EGC) are limited. We aimed to compare the long-term outcomes of ESD and surgery for patients with EGC. METHODS: Data were reviewed from patients treated by ESD or surgery for EGC in 2005-2010. The primary outcome was overall survival (OS). Secondary outcomes were disease-specific survival (DSS), disease-free survival (DFS), recurrence-free survival (RFS), treatment-related complications, and hospital stay duration. RESULTS: Among 617 patients, 342 underwent ESD and 275 underwent surgery. The 5-year OS rates were similar between the ESD group and the surgery group (96.9% vs 98.1%, P = 0.581). In a propensity-score-matched analysis of 117 pairs, there were no significant differences in the OS rates (96.5% vs 99.1%, P = 0.125) and DSS rates (100% vs 99.1%, P = 0.317) between the ESD group and the surgery group. The ESD group had a significantly lower DFS rate (90.3% vs 98.0%, P = 0.002), a significantly lower RFS rate (95.1% vs 98.0%, P = 0.033), a significantly higher early complication rate (6.7% vs 1.5%, P < 0.001), a significantly lower late complication rate (0% vs 9.1%, P < 0.001), and a significantly shorter median hospital stay (3 days vs 10 days, P < 0.001) than the surgery group. CONCLUSIONS: ESD and surgery have comparable OS rates in patients with EGC. ESD has benefits, including a lower late complication rate and shorter hospital stay. However, RFS and DFS rates might be lower after ESD than after surgery.

Endoscopic submucosal dissection for undifferentiated-type early gastric cancer: short- and long-term outcomes.

BACKGROUND AND AIMS: Application of endoscopic submucosal dissection (ESD) for undifferentiated-type early gastric cancers (EGCs) remains controversial owing to limited data regarding long-term outcomes. We aimed to evaluate the feasibility of ESD for undifferentiated-type EGCs that meet the expanded criteria (EC). METHODS: We performed a retrospective analysis of 66 patients who underwent ESD for undifferentiated-type EGC between January 2005 and December 2014. We evaluated the rates of en bloc, complete, and curative resections along with overall survival (OS), disease-specific survival (DSS), and recurrence-free survival (RFS). RESULTS: Of the 66 patients, the EC group included 38 patients and the beyond-EC group included 28 patients. The overall rates of en bloc, complete, and curative resection of the 66 lesions were 92.4% (61/66), 65.2% (43/66), and 48.5% (32/66), respectively. Of the 34 patients with non-curative resection, 18 underwent additional surgery. Local remnant cancer was detected in 1 patient (1/18, 5.6%), and none of the 18 patients had lymph node metastasis. On multivariate analysis, tumors > 2 cm [odd ratio (OR) 6.183, 95% confidence interval (CI) 1.279-29.880, p = 0.023) and submucosal invasion depth (OR 6.226, 95% CI 1.881-20.606, p = 0.003) were independent predictors of incomplete resection. All 26 patients with more than 1 year of follow-up after curative resection survived without any evidence of local or distant recurrences over a median follow-up period of 36 months. The OS, DSS, and RFS rates of patients with curative ESD were 93.8, 100, and 100%, respectively. CONCLUSIONS: ESD may have favorable long-term outcomes in patients with undifferentiated-type EGC after curative resection.

Endoscopic submucosal dissection for esophagogastric junction tumors: a single-center experience.

BACKGROUND: Surgical resection for esophagogastric junction (EGJ) tumors is more aggressive and worsens the quality of life of the patients and leads to poor prognosis even after surgery compared with tumors in other sites of the stomach. Endoscopic submucosal dissection (ESD) is a widely accepted treatment modality for premalignant lesions and early cancers in the stomach. However, EGJ tumor is one of the most technically difficult lesions to resect by ESD. Therefore, this study aimed to evaluate the therapeutic outcomes of ESD for EGJ epithelial neoplasms and to assess the predictive factors for incomplete resection. METHODS: We conducted a retrospective observational study of 48 patients who underwent ESD for adenomas and early cancers of the EGJ between March 2006 and November 2015 at the Pusan National University Hospital. Therapeutic outcomes of ESD and procedure-related adverse events were analyzed. RESULTS: En bloc resection, complete resection, and curative resection rates were 96, 77, and 71%, respectively. Multivariate analyses showed that the presence of ulceration was an independent predictive factor for incomplete resection (odds ratio 21.3, 95% confidence interval 1.51-298.49; p = 0.023). The procedure-related bleeding, perforation, and stenosis rates were 8, 4, and 0%, respectively; none of the adverse events required surgical intervention. During a median follow-up period of 25 months (range 6-72 months), local recurrence occurred in four patients with incomplete resection. CONCLUSION: ESD is an effective, safe, and feasible treatment for EGJ epithelial neoplasms. However, the complete resection rate decreases for tumors with ulceration.

Prevalence of Malnutrition in Hospitalized Patients: a Multicenter Cross-sectional Study.

BACKGROUND: Malnutrition is associated with many adverse clinical outcomes. The present study aimed to identify the prevalence of malnutrition in hospitalized patients in Korea, evaluate the association between malnutrition and clinical outcomes, and ascertain the risk factors of malnutrition. METHODS: A multicenter cross-sectional study was performed with 300 patients recruited from among the patients admitted in 25 hospitals on January 6, 2014. Nutritional status was assessed by using the Subjective Global Assessment (SGA). Demographic characteristics and underlying diseases were compared according to nutritional status. Logistic regression analysis was performed to identify the risk factors of malnutrition. Clinical outcomes such as rate of admission in intensive care units, length of hospital stay, and survival rate were evaluated. RESULTS: The prevalence of malnutrition in the hospitalized patients was 22.0%. Old age (≥ 70 years), admission for medical treatment or diagnostic work-up, and underlying pulmonary or oncological disease were associated with malnutrition. Old age and admission for medical treatment or diagnostic work-up were identified to be risk factors of malnutrition in the multivariate analysis. Patients with malnutrition had longer hospital stay (SGA A = 7.63 ± 6.03 days, B = 9.02 ± 9.96 days, and C = 12.18 ± 7.24 days, P = 0.018) and lower 90-day survival rate (SGA A = 97.9%, B = 90.7%, and C = 58.3%, P < 0.001). CONCLUSION: Malnutrition was common in hospitalized patients, and resulted in longer hospitalization and associated lower survival rate. The rate of malnutrition tended to be higher when the patient was older than 70 years old or hospitalized for medical treatment or diagnostic work-up compared to elective surgery.

Two staging systems for gastrointestinal stromal tumors in the stomach: which is better?

BACKGROUND: The prognosis of a gastrointestinal stromal tumor (GIST) is influenced by its anatomic site; however, few studies on the prognosis of gastric GISTs have been reported. The aims of this study were to evaluate long-term prognoses of patients who underwent surgical resection for gastric GISTs and to compare the clinical efficacy of two staging systems: the National Institutes of Health (NIH) consensus criteria and the 7th Union for International Cancer Control/American Joint Committee on Cancer (UICC/AJCC) tumor-node-metastasis (TNM) staging system. METHODS: We conducted a retrospective observational study of 145 patients who underwent surgical resection for gastric GISTs between February 2001 and June 2012 at Pusan National University Hospital (Busan, Korea). Recurrence and 5-year recurrence-free survival (RFS) rates were analyzed. RESULTS: During a median follow-up period of 44 months (range, 6-144 months), 11 recurrent lesions were detected in 9 patients (6.4%). On multivariate analysis, tumor size (>5 cm), mitotic count (>5/50 high-power fields), and epithelioid and mixed pathological type were significantly associated with recurrence. The overall 5-year RFS rate was 93.4%. Although no statistically significant differences were detected (C-statistic difference P = 0.886), all metrics showed lower values for the UICC/AJCC TNM staging system than for the NIH consensus criteria, suggesting that the UICC/AJCC TNM staging system may be a better model. CONCLUSIONS: The 5-year RFS rate in patients who underwent curative resection for gastric GISTs was excellent. The UICC/AJCC TNM staging system may be more useful than the NIH consensus criteria for risk categorization of patients with gastric GISTs.

Endoscopic submucosal dissection for papillary adenocarcinoma of the stomach: is it really safe?

BACKGROUND: Papillary adenocarcinoma of the stomach has been treated according to the same endoscopic submucosal dissection (ESD) indication criteria as other differentiated-type adenocarcinomas. We aimed to compare lymph node metastasis (LNM) in patients with early gastric cancer (EGC) with papillary adenocarcinoma (EGC-P) with that in patients with EGC with nonpapillary adenocarcinoma (EGC-NP) and to consider the potential limitation of current ESD indication criteria in the treatment of EGC-P. METHODS: In total, 1583 patients who underwent gastrectomy for EGC from 2005 to 2014 were included. Clinicopathologic characteristics of 56 patients with EGC-P were compared with those of 1527 patients with EGC-NP. The safety of ESD was evaluated, by application of current ESD indication criteria to EGC-P. RESULTS: The frequency of submucosal invasion was significantly higher in EGC-P than in both EGC-NP with differentiated-type histologic appearance and EGC-NP with undifferentiated-type histologic appearance (71.4% vs 50.8% and 37.6%, respectively). In addition, the frequency of LNM in EGC-P was 17.9%, higher than that in both EGC-NP with differentiated-type histologic appearance and EGC-NP with undifferentiated-type histologic appearance (9.7% and 11.1%, respectively). When the current ESD indication criteria were applied to the 56 patients with EGC-P, 17 patients met the current indications. Of these patients, two (11.8%) had LNM and three (17.6%) had lymphovascular invasion (LVI). When LNM and LVI were combined, one of seven patients (16.7%) meeting the absolute ESD indications and three of ten patients (30.0%) meeting the expanded ESD indications would not be cured after ESD. CONCLUSIONS: The use of ESD should be more carefully applied in patients with EGC-P meeting the ESD indication criteria, especially the expanded indication criteria, after pretreatment workup compared with other differentiated-type adenocarcinomas, owing to the higher frequencies of submucosal invasion, LNM, and LVI in EGC-P.

Endoscopic resection for duodenal subepithelial tumors: a single-center experience.

BACKGROUND: Subepithelial tumors (SETs) in the gastrointestinal tract are often incidentally found during endoscopic examinations. Although the utility and safety of endoscopic resection (ER) of SETs in the esophagus and stomach have been described, data about the ER of duodenal SETs remain scant. Therefore, we aimed to investigate the clinical outcomes associated with the ER of duodenal SETs and to assess possible predictive factors for incomplete resection. METHODS: We conducted a retrospective observational study of 62 patients (64 lesions) that underwent ER of duodenal SETs between June 2005 and December 2015 at the Pusan National University Hospital. The therapeutic outcomes from ER and procedure-related complications were analyzed. RESULTS: Endoscopic mucosal resection (EMR) was performed in 38 tumors, EMR with a ligation device (EMR-L) in 18 and endoscopic submucosal dissection (ESD) in 8. The overall en bloc resection and complete ER rates were 96.9 % (62/64) and 100 % (64/64), respectively. The complete pathologic resection rate was 76.6 % (49/64). Multivariate logistic regression analyses determined that the macroscopic type (Yamada type I or II; odds ratio [OR] 6.460, 95 % confidence interval [CI] 1.569-37.458, p = 0.027) and the treatment method (ESD; OR 7.178, 95 % CI 1.291-39.323, p = 0.024) were independently associated with incomplete pathologic resection. The procedure-related bleeding and perforation rates were 6.3 % and 4.7 %, respectively. No recurrences were observed in patients who had undergone complete ER at a median follow-up period of 20 months (range 6-112 months). CONCLUSION: ER is an effective, safe, and feasible treatment for duodenal SETs, especially when the SET is located in the deep mucosal layer and/or the submucosal layer.

Clinicopathologic features of early gastric carcinoma with lymphoid stroma and feasibility of endoscopic submucosal dissection.

BACKGROUND: Gastric carcinoma with lymphoid stroma (GCLS) is a rare disease known to have unique features and a favorable prognosis. This study aimed to determine the clinicopathologic features of early GCLS (EGCLS) and define the feasibility of endoscopic submucosal dissection (ESD) for EGCLS. METHODS: We performed a retrospective analysis of 70 EGCLS patients treated via ESD or surgery and 1626 patients who underwent surgical resection for early non-GCLS (ENGCLS) between January 2007 and December 2014 at Pusan National University Hospital, Busan, Republic of Korea. RESULTS: The mean age of EGCLS patients was 58 years (range 36-77 years); a male predominance (3.7:1) was observed, and 81.4% showed Epstein-Barr virus positivity. Compared with ENGCLS, EGCLS was macroscopically more elevated (34.3 vs. 18.0%, P = 0.003) and located more proximally (upper third: 37.1 vs. 9.7%, P < 0.001). Tumor size was smaller (2.1 ± 1.1 vs. 3.1 ± 2.0 cm, P < 0.001), but submucosal invasion was more frequent (77.1 vs. 44.4%, P < 0.001) and deeper in the EGCLS group. Among the 59 EGCLS patients who were treated surgically, only two (3.4%) showed lymph node metastasis (LNM). Despite submucosal invasion, EGCLS showed a lower LNM rate (4.0 vs. 19.4%, P = 0.007) than ENGCLS, even in patients with SM3 EGCLS (5.3 vs. 24.5%, P = 0.007). There were no recurrences in the available ten patients who underwent ESD alone during a mean follow-up of 37.2 months. CONCLUSIONS: In this study, we observed unique clinicopathologic features with a very low LNM rate in EGCLS. We consider ESD a potentially curative treatment strategy for EGCLS despite deep submucosal invasion, especially in patients with poor performance status and significant comorbidities.

Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study.

This study compared the efficacy of DA-9601 (Dong-A ST Co., Seoul, Korea) and its new formulation, DA-5204 (Dong-A ST Co.), for treating erosive gastritis. This phase III, randomized, multicenter, double-blind, non-inferiority trial randomly assigned 434 patients with endoscopically proven gastric mucosal erosions into two groups: DA-9601 3 times daily or DA-5,204 twice daily for 2 weeks. The final analysis included 421 patients (DA-5204, 209; DA-9601, 212). The primary endpoint (rate of effective gastric erosion healing) and secondary endpoints (cure rate of endoscopic erosion and gastrointestinal [GI] symptom relief) were assessed using endoscopy after the treatment. Drug-related adverse events (AEs), including GI symptoms, were also compared. At week 2, gastric healing rates with DA-5204 and DA-9601 were 42.1% (88/209) and 42.5% (90/212), respectively. The difference between the groups was -0.4% (95% confidence interval, -9.8% to 9.1%), which was above the non-inferiority margin of -14%. The cure rate of gastric erosion in both groups was 37.3%. The improvement rates of GI symptoms with DA-5204 and DA-9601 were 40.4% and 40.8%, respectively. There were no statistically significant differences between the two groups in both secondary endpoints. AEs were reported in 18 (8.4%) patients in the DA-5204 group and 19 (8.8%) in the DA-9601 group. Rates of AE were not different between the two groups. No serious AE or adverse drug reaction (ADR) occurred. These results demonstrate the non-inferiority of DA-5204 compared to DA-9601. DA-5204 is as effective as DA-9601 in the treatment of erosive gastritis. Registered randomized clinical trial at ClinicalTrials.gov (NCT02282670).

Once-Daily OROS Hydromorphone for Management of Cancer Pain: an Open-Label, Multi-Center, Non-Interventional Study.

Extended-release osmotic extended-release oral delivery system (OROS) hydromorphone is a strong synthetic opioid designed to maintain a constant blood concentration by once daily dosing. The objective of this observational study was to investigate the clinical usefulness of OROS hydromorphone in patients with cancer pain of moderate to severe intensity. Patients with cancer pain who required strong opioids were administered with OROS hydromorphone for 4 weeks. We assessed changes in pain intensity using a numerical rating scale (NRS) as well as levels of sleep disturbance, breakthrough pain, end-of-dose failure, patient satisfaction, and overall assessment of drug effectiveness based on investigator evaluation. Of the 648 enrolled patients, 553 patients were included in the full analysis set. The mean pain intensity was significantly decreased from the NRS value of 5.07 ± 1.99 to 2.75 ± 1.94 (mean % change of 42.13 ± 46.53, P < 0.001). The degree of sleep disturbance significantly improved (mean NRS change of 1.61 ± 2.57, P < 0.001), and the incidence of breakthrough pain was significantly decreased (mean NRS change of 1.22 ± 2.30, P < 0.001). The experience of end-of-dose failure also significantly decreased from 4.60 ± 1.75 to 3.93 ± 1.70, P = 0.007). The patient satisfaction rate was 72.7%, and 72.9% of investigators evaluated the study drug as effective. OROS hydromorphone was an effective and tolerable agent for cancer pain management. It effectively lowered pain intensity as well as improved sleep disturbance, breakthrough pain, and end-of-dose failure.