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BACKGROUND/AIMS: Gastric subepithelial tumors (SETs) are often encountered during the upper gastrointestinal endoscopic screening. We assessed the prevalence of gastric SETs and the risk factors for their progression. METHODS: We reviewed the electronic medical records of 30,754 patients who underwent upper gastrointestinal endoscopic screening at our medical center between January 2013 and December 2016. RESULTS: Among the 30,754 patients examined, 599 (1.94%) had gastric SETs. The prevalence increased with age and was 9.56% in patients aged ≥70 years. In total, 262 patients underwent serial endoscopy for more than 6 months. The median age was 68 years (interquartile range [IQR], 61-74), and the number of females was 167 (63.7%). During a median follow-up of 58 months (IQR, 38-75), 22 patients (8.4%) showed significant changes in tumor size. An irregular border (odds ratio, 4.623; 95% confidence interval, 1.093-19.558; p=0.037) was a significant risk factor for progression. Seven patients underwent surgical or endoscopic resections. The pathologies of gastric SETs included leiomyomas (n=3), gastrointestinal stromal tumors (n=2), and lipomas (n=2). CONCLUSIONS: The prevalence of gastric SETs increases with age. Most gastric SETs do not progress during long-term endoscopic examinations, and the risk of an increase in size is low in asymptomatic small SETs without irregular borders.
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Duodenal neuroendocrine tumors (NETs) are subepithelial tumors that are difficult to remove endoscopically, particularly when located just beyond the pylorus. This paper reports a case of a successful endoscopic submucosal dissection (ESD) using open gastric peroral endoscopic myotomy (POEM) for a remnant duodenal NET detected after endoscopic mucosal resection (EMR). A 67-year-old male presented with a 5 mm remnant duodenal NET close to the pylorus after EMR for a duodenal polypoid lesion performed four months earlier. Duodenal ESD was performed under conscious sedation using I-type and IT II knives. The tumor adhered to the fibrotic tissue, and the submucosal cushion was insufficient. Open gastric POEM was performed concurrently during ESD, resulting in the complete resection of the NET. This case suggests that while challenging, open gastric POEM can serve as a valuable technique for endoscopic resection in cases of early gastric cancer or duodenal masses located around the pylorus.
Subject(s)
Duodenal Neoplasms , Endoscopic Mucosal Resection , Esophageal Achalasia , Intestinal Neoplasms , Myotomy , Neuroendocrine Tumors , Pancreatic Neoplasms , Stomach Neoplasms , Male , Humans , Aged , Endoscopic Mucosal Resection/methods , Stomach Neoplasms/surgery , Treatment Outcome , Neuroendocrine Tumors/diagnosis , Neuroendocrine Tumors/surgery , Neuroendocrine Tumors/pathology , Esophageal Sphincter, Lower/pathology , Duodenal Neoplasms/surgery , Duodenal Neoplasms/pathologyABSTRACT
Background/Aims: H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibiting gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA. However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis. Methods: A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set included 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared. Results: According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different. Conclusions: DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, lowdose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756).
Subject(s)
Famotidine , Gastritis , Humans , Famotidine/therapeutic use , Histamine H2 Antagonists/therapeutic use , Gastritis/drug therapy , Proton Pump Inhibitors/therapeutic use , Double-Blind MethodABSTRACT
Background/Aims: : This study aimed to review the indications, methods, cooperation, complications, and outcomes of percutaneous endoscopic gastrostomy (PEG). Methods: : Questionnaires were sent to 200 hospitals, of which 62 returned their questionnaires, with a response rate of approximately 30%. Descriptive statistics were calculated to analyze the responses to the questionnaires. Results: : In 2019, a total of 1,052 PEGs were performed in 1,017 patients at 62 hospitals. The main group who underwent PEG was older adult patients with brain disease, particularly stroke. Nutritional supply was an important purpose of the PEG procedure. "The pull method" was the most commonly used for initial PEG insertion. The complications related to PEG were mostly mild, with leakage being the most common. Patients who underwent PEG procedures were primarily educated regarding the post-procedure management and complications related to PEG. Preoperative meetings were skipped at >50% of the institutions. Regarding the cooperation between the nutrition support team (NST) and the physician performing PEG, few endoscopists answered that they cooperated with NST before and after PEG. Moreover, the rate of NST certification obtained by physicians performing PEG and the frequency of attendance at NST-related conferences were relatively low. Conclusions: : This study shows a similar trend to that found in the previous PEG guidelines. However, it covers new aspects, including team-based work for PEG procedure, nutrition support, and education for patients and guardians. Therefore, each medical institution needs to select an appropriate method considering the medical environment and doctor's abilities.
Subject(s)
Enteral Nutrition , Gastrostomy , Humans , Aged , Enteral Nutrition/methods , Gastrostomy/methods , Gastroscopy/methods , Surveys and Questionnaires , Republic of Korea , Retrospective StudiesABSTRACT
Esophageal actinomycosis is a rare, chronic granulomatous disease caused by Actinomyces species. Endoscopy and biopsy are essential for making a diagnosis. This paper reports a case of esophageal actinomycosis that developed after an endoscopic mucosal resection (EMR) for a subepithelial tumor (SET). A 74-year-old male patient had a 3 cm flat, smooth elevation in the esophagus without symptoms. The SET was partially resected, and histology revealed "nonspecific degenerated mesenchymal tissue". Three months later, the patient exhibited a persistently large ulceration at the EMR site, and a biopsy revealed actinomycosis. CT of the chest and abdomen revealed no abnormal findings. Ampicillin treatment was administered for six months, and the ulceration on the esophageal SET improved.
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Extensive endoscopic submucosal dissection (ESD) for gastric adenoma or early cancer can lead to post-ESD stenosis. This may cause a decrease in quality of life and an increase in medical issues. Therefore, this study examined the safety and effectiveness of gastric open peroral endoscopic myotomy (GO-POEM) in preventing stenosis following ESD. A retrospective investigation was carried out on 31 patients who underwent gastric ESD forâ >â 75% of the lumen in the antrum or pylorus at the Presbyterian Medical Center in Korea between December 2004 and October 2022. The patients were divided into GO-POEM (nâ =â 11) and non-GO-POEM groups (nâ =â 20). The average age of the 31 patients was 73.23 years, and 18 were male. There were no differences in age, sex, location, gross findings, or procedure time between the 2 groups. In the GO-POEM group, only 1 patient (9 %) developed stenosis, compared to 11 patients (55 %) in the control group (Pâ =â .02). Multivariate analysis showed that the GO-POEM group had a significantly lower risk of post-ESD stenosis (Pâ <â .05). Stenosis symptoms resolved with a single endoscopic balloon dilatation (EBD) in 1 patient in the GO-POEM group. In contrast, 5 of 11 patients with stenosis in the non-GO-POEM group required a median of 2 EBD sessions (range, 1-8). GO-POEM may be an effective and reliable method for preventing stenosis post extensive gastric ESD. Further investigations are necessary to establish its efficacy and safety.
Subject(s)
Endoscopic Mucosal Resection , Esophageal Achalasia , Myotomy , Natural Orifice Endoscopic Surgery , Humans , Male , Aged , Female , Constriction, Pathologic , Endoscopic Mucosal Resection/adverse effects , Retrospective Studies , Quality of Life , Treatment Outcome , Natural Orifice Endoscopic Surgery/methodsABSTRACT
BACKGROUND/AIMS: Endoscopic submucosal dissection (ESD) is an effective method for resecting gastric adenomas and adenocarcinomas. A significant discrepancy was observed between endoscopic and pathological sizes in samples obtained from patients undergoing ESD. This study elucidates the factors affecting size discrepancy after formalin fixation. METHODS: The records of 64 patients with 69 lesions were analyzed, including 50 adenomas and 19 adenocarcinomas. Data on location, gross shape, histology, and size after fixation in formalin were collected. RESULTS: The mean size of the resected specimen appeared to decrease after formalin fixation (37.5 mm prefixation vs. 35.8 mm postfixation, p<0.05). The mean long axis diameter of the lesions was 20.3±7.9 mm prefixation and 13.4±7.9 mm postfixation. Size differences in lesions smaller than 20 mm were significantly greater than those in lesions larger than 20 mm (7.6±5.6 mm vs. 2.5±5.8 mm, p<0.01). In multivariate analysis, a tumor size of ≥20 mm was found to be an independent factor affecting size postformalin fixation (p<0.05). CONCLUSION: The endoscopic size of lesions before ESD may be underestimated in tumors larger than 20 mm in size. Therefore, increased attention must be paid during ESD to avoid instances of incomplete resection.
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Soil salinity is major threat to crop growth and reducing cultivated land areas and salt-resistant crops have been required to sustain agriculture in salinized areas. This original research was performed to determine the effectiveness of MgSO4 (MS) and CaSO4 (CS) for each species and assess changes in the physiology and growth of fodder crops after short and long-term salt stress. Six treatments (CON (control); NaCl (NaCl 100 mM); 1 MS (1 mM MgSO4 + 100 mM NaCl); 2 MS (2 mM MgSO4 + 100 mM NaCl); 7.5 CS (7.5 mM CaSO4 + 100 mM NaCl); and 10 CS (10 mM CaSO4 + 100 mM NaCl)) were applied to Red clover (Trifolium pratense) and Tall fescue (Festuca arundinacea) under greenhouse conditions. Cultivars were evaluated based on their dry weights, physiological parameters, forage quality, and ion concentrations. The biomass of both species decreased significantly under NaCl treatments and increased under the MS and CS treatments compared to solely salinity treatments. Salinity caused a decrease in the photosynthetic rate, but compared to CON, the MS and CS treatments yielded superior results. Moreover, the Na+/K+ ratio increased as Na+ concentration increased but crop quality (CP, NDF, ADF) did not show significant differences under salinity. Overall, we concluded that these T. pratense and F. arundinacea species demonstrated various responses to salinity, MS, and CS by different physiological and morphological parameters and it turned out to be efficient under salinity stress.
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BACKGROUND: Endoscopic submucosal dissection (ESD) can provide a high en bloc resection rate and has been widely applied as curative treatment for early colorectal cancer (ECC). However, surgical treatment is occasionally required, and reports on the long-term prognosis of ESD are insufficient. This study aimed to investigate the long-term outcomes of ECC removal by ESD, including local recurrence and metastasis. METHODS: This multicenter study was conducted retrospectively on 450 consecutive patients with ECC who were treated with ESD between November 2003 and December 2013. Clinical, pathological, and endoscopic data were collected to determine tumor depth, resection margin, lymphovascular invasion, and recurrence. RESULTS: The median follow-up period was 53.8 (12-138 months). The en bloc resection rate was 85.3% (384) and in intramucosal cancer being 84.1% and in superficial submucosal invasion (SM1) cancer being 89.8% (p = 0.158). The curative resection rate was 76.0% (n = 342), and there was no statistical difference between the two groups (77.3% vs. 71.4%, p = 0.231). The overall recurrence free survival rate (RFS) was 98.7% (444/450). In patients with curative resection, there was no statistically significant difference in RFS according to invasion depth (intramucosal: 99.3% vs. SM1: 97.1%, p = 0.248). CONCLUSIONS: Patients with curatively resected ECC treated with ESD showed favorable long-term outcomes. Curatively resected SM1 cancer has a RFS similar to that of intramucosal cancer.
Subject(s)
Colorectal Neoplasms , Endoscopic Mucosal Resection , Colorectal Neoplasms/pathology , Colorectal Neoplasms/surgery , Humans , Prognosis , Retrospective StudiesABSTRACT
A 52-year-old woman with a gastric outlet obstruction (GOO) caused by pyloric cancer underwent pyloric endoscopic self-expandable metal stent (SEMS) insertion. She presented with abdominal distension 40 days later. The SEMS was dysfunctional, and endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) was performed using an endoscopic nasobiliary drainage tube. A 16 mm×31 mm Niti-S ™ HOT SPAXUS™ (TaeWoong Medical, Gimpo, Korea) was inserted successfully between the stomach and the adjacent jejunum. After the procedure, the patient had a good oral intake for more than seven months. GOO is a mechanical obstructive condition caused by various benign and malignant conditions. Traditionally, surgical GJ and SEMS insertion have been used to treat GOOs. EUS-GJ is a feasible treatment option for patients with GOO and a pyloric metal stent dysfunction.
Subject(s)
Gastric Bypass , Gastric Outlet Obstruction , Neoplasms , Self Expandable Metallic Stents , Endosonography/adverse effects , Female , Gastric Bypass/adverse effects , Gastric Bypass/methods , Gastric Outlet Obstruction/diagnosis , Gastric Outlet Obstruction/etiology , Gastric Outlet Obstruction/surgery , Humans , Middle Aged , Neoplasms/complications , Palliative Care/methods , Retrospective Studies , Self Expandable Metallic Stents/adverse effects , Stents/adverse effectsABSTRACT
OBJECTIVE: Endoscopic resection of over 3/4 of the lumen of the antrum or pylorus is a known risk factor for post-endoscopic submucosal dissection (ESD) stenosis. Local or systemic steroids may reduce the risk of stenosis, but their overall role in stenosis prevention remains controversial. We aimed to evaluate the efficacy and safety of prophylactic gastric open peroral endoscopic myotomy (GO-POEM) in preventing post-ESD stenosis. METHODS: Ten patients who underwent GO-POEM during or immediately after ESD in the Presbyterian Medical Center between June 2017 and November 2020 were included. All patients underwent excision of over 3/4 of the lumen of the antrum or pylorus. GO-POEM was performed without submucosal tunneling. RESULTS: Well-differentiated tubular adenocarcinoma, tubulovillous adenoma with high-grade dysplasia, and tubular adenoma with low-grade dysplasia were diagnosed in three, one, and six patients, respectively. GO-POEM was performed successfully in all the 10 patients. Stenosis could not be evaluated in one patient, whereas one of the remaining nine patients developed post-ESD stenosis. GO-POEM decreased the risk of post-ESD stenosis in the other eight patients. Two patients presented with intraprocedural bleeding, both of whom were managed endoscopically successfully. CONCLUSIONS: Prophylactic GO-POEM may be a novel, effective and safe treatment modality for preventing post-ESD stenosis in the stomach. Well-designed, multicenter studies with large sample sizes are needed to confirm our results.
Subject(s)
Adenoma , Endoscopic Mucosal Resection , Myotomy , Adenoma/etiology , Adenoma/surgery , Constriction, Pathologic/etiology , Endoscopic Mucosal Resection/adverse effects , Humans , Stomach , Treatment OutcomeABSTRACT
BACKGROUND/AIMS: The utility of endoscopic ultrasonography (EUS) for differentiating gastrointestinal stromal tumors (GISTs) and leiomyomas of the stomach is not well known. We aimed to evaluate the ability of EUS for differentiating gastric GISTs and leiomyomas. METHODS: We retrospectively reviewed the medical records of patients with histopathologically proven GISTs (n=274) and leiomyomas (n=87). In two consensus meetings, the inter-observer variability in the EUS image analysis was reduced. Using logistic regression analyses, we selected predictive factors and constructed a predictive model and nomogram for differentiating GISTs from leiomyomas. A receiver operating characteristic (ROC) curve analysis was performed to measure the discrimination performance in the development and internal validation sets. RESULTS: Multivariate analysis identified heterogeneity (odds ratio [OR], 9.48), non-cardia (OR, 19.11), and older age (OR, 1.06) as independent predictors of GISTs. The areas under the ROC curve of the predictive model using age, sex, and four EUS factors (homogeneity, location, anechoic spaces, and dimpling or ulcer) were 0.916 (sensitivity, 0.908; specificity, 0.793) and 0.904 (sensitivity, 0.908; specificity, 0.782) in the development and internal validation sets, respectively. CONCLUSION: The predictive model and nomogram using age, sex and homogeneity, tumor location, presence of anechoic spaces, and presence of dimpling or ulcer on EUS may facilitate differentiation between GISTs and leiomyomas.
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Cannulation of the portal vein is a rare complication of ERCP. This paper reports a case of portal vein catheterization during ERCP in a patient with choledocholithiasis. A 62-year-old man was admitted to the Presbyterian Medical Center with right upper quadrant pain and jaundice. ERCP was performed under the suspicion of obstructive jaundice caused by a radiolucent stone. Bile duct cannulation using a pull-type papillotome was attempted, but it failed. After needle-knife fistulotomy, wire-guided cannulation was performed successfully, and 10 mL contrast was injected. On the other hand, the fluoroscopy image showed that the contrast medium disappeared very quickly. Pure blood was collected when the catheter was aspirated to identify the bile reflux, indicating possible cannulation of the portal vein. The procedure was terminated immediately and abdominal computed tomography showed air in the portal vein. One day after, a follow-up CT scan showed no air in the portal vein. The patient underwent repeated ERCP, and the common bile duct was cannulated. In most cases, isolated portal vein cannulation does not result in severe morbidity. However, it is important to aware of this rare complication so that no further invasive procedure is performed on the patient.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Choledocholithiasis , Catheterization/adverse effects , Choledocholithiasis/diagnosis , Choledocholithiasis/surgery , Common Bile Duct/surgery , Humans , Male , Middle Aged , Portal Vein , Sphincterotomy, EndoscopicABSTRACT
BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD. METHODS: This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment. RESULTS: A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, P = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events. CONCLUSIONS: The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.
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BACKGROUND AND AIMS: Delayed bleeding is an important adverse event after colorectal endoscopic submucosal dissection (ESD). We aimed to investigate the incidence and risk factors of delayed bleeding after colorectal ESD and to develop a risk-scoring model for predicting delayed bleeding. METHODS: This retrospective study was performed at 5 centers. The derivation and validation cohorts comprised 1189 patients from 1 center and 415 patients from the other 4 centers. We investigated the incidence and risk factors of delayed bleeding. Then, we developed a risk-scoring model for predicting delayed bleeding by using the data of the derivation cohort. We validated the scoring system in the validation cohort. RESULTS: Delayed bleeding occurred in 34 patients (2.9%) in the derivation cohort. In multivariate analysis, the risk factors of delayed bleeding were tumor location in the rectosigmoid colon (odds ratio [OR], 6.49; 95% confidence interval [CI], 1.96-21.42; P = .002), large tumor (≥30 mm) (OR, 2.10; 95% CI, 1.01-4.40; P = .048), and use of antiplatelet agents except for aspirin alone (OR, 4.04; 95% CI, 1.44-11.30; P = .008). These 3 factors were incorporated into a risk-scoring model for prediction of delayed bleeding. As the score based on this system increased, the incidence of delayed bleeding increased in the validation cohort. CONCLUSION: The risk-scoring model incorporating tumor location, tumor size, and use of antiplatelet agents can quantitatively predict the risk of delayed bleeding after colorectal ESD.
Subject(s)
Colorectal Neoplasms/surgery , Endoscopic Mucosal Resection/adverse effects , Gastrointestinal Hemorrhage/etiology , Postoperative Hemorrhage/epidemiology , Age Factors , Aged , Cohort Studies , Colorectal Neoplasms/pathology , Endoscopic Mucosal Resection/methods , Female , Follow-Up Studies , Gastrointestinal Hemorrhage/epidemiology , Gastrointestinal Hemorrhage/physiopathology , Humans , Incidence , Logistic Models , Male , Middle Aged , Multivariate Analysis , Postoperative Hemorrhage/diagnosis , Predictive Value of Tests , Republic of Korea , Retrospective Studies , Risk Assessment , Sex Factors , Time FactorsABSTRACT
BACKGROUND: The Korean College of Helicobacter and Upper Gastrointestinal Research has studied Helicobacter pylori (H. pylori) prevalence since 1998 and found a dynamic change in its prevalence in Korea. The aim of this study was to determine the recent H. pylori prevalence rate and compare it with that of previous studies according to socioeconomic variables. METHODS: We planned to enroll 4920 asymptomatic Korean adults from 21 centers according to the population distribution of seven geographic areas (Seoul, Gyeonggi, Gangwon, Chungcheong, Kyungsang, Cholla, and Jeju). We centrally collected serum and tested H. pylori serum IgG using a chemiluminescent enzyme immunoassay. RESULTS: We analyzed 4917 samples (4917/4920 = 99.9%) from January 2015 to December 2016. After excluding equivocal serologic results, the H. pylori seropositivity rate was 51.0% (2414/4734). We verified a decrease in H. pylori seroprevalence compared with previous studies performed in 1998, 2005, and 2011 (P < .0001). The H. pylori seroprevalence rate differed by area: Cholla (59.5%), Chungcheong (59.2%), Kyungsang (55.1%), Jeju (54.4%), Gangwon (49.1%), Seoul (47.4%), and Gyeonggi (44.6%). The rate was higher in those older than 40 years (38.1% in those aged 30-39 years and 57.7% in those aged 40-49 years) and was lower in city residents than in noncity residents at all ages. CONCLUSIONS: Helicobacter pylori seroprevalence in Korea is decreasing and may vary according to population characteristics. This trend should be considered to inform H. pylori-related policies.
Subject(s)
Helicobacter pylori/pathogenicity , Adolescent , Adult , Aged , Female , Helicobacter Infections/epidemiology , Humans , Male , Middle Aged , Republic of Korea/epidemiology , Seroepidemiologic Studies , Young AdultABSTRACT
BACKGROUND AND AIM: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is commonly used to obtain tissue external to the gastrointestinal tract. EUS-FNA is relatively safe, but occasionally adverse events have been reported. There is scarcity of data on risk factors of adverse events. The aim of this study is to identify risk factors associated with EUS-FNA. METHODS: In this multicenter case-control study, we retrospectively reviewed 4,097 cases between 2009 and 2012 at 15 hospitals in Korea. Among the patients there were 104 cases (2.5%) who had adverse events of which 12 (0.29%) were severe. We matched 520 controls (1:5 ratios) stratified by hospital to analyze the potential risk factors. RESULTS: The most common adverse events were pancreatitis (45/104, 43.3%) and infection (46/104, 44.2%). Endoscopic retrograde cholangiopancreatography (ERCP) on the same day was a risk factor of all adverse events [OR = 2.41, 95% CI (1.41, 4.12)], pancreatitis [OR = 2.31, 95% CI (1.02, 5.25)], and infection [OR = 2.75, 95% CI (1.31, 5.78)]. More than 15 to-and-fro movements during puncture increased the risk of pancreatitis [OR = 2.30, 95% CI (1.11, 4.77)] and infection [OR = 3.65, 95% CI (1.55, 8.59)]. A higher number of punctures was positively correlated with pancreatitis [OR = 1.34, 95% CI (1.08, 1.67)] but negatively correlated with infection [OR = 0.66, 95% CI (0.48, 0.89)]. CONCLUSIONS: EUS-FNA is a safe procedure in which serious adverse events are rare. We define some risk factors of adverse events during EUS-FNA, including ERCP on the same day, a higher number of punctures, and more than 15 to-and-fro movements.
Subject(s)
Biopsy, Needle/methods , Endoscopy/adverse effects , Ultrasonography , Adult , Aged , Aged, 80 and over , Case-Control Studies , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors , Young AdultABSTRACT
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).