Efficacy and safety of CKD-495 in acute and chronic gastritis: A Phase III superiority clinical trial.

BACKGROUND: Despite the availability of numerous treatment options, many patients with gastritis experience only partial symptom relief. CKD-495, a newly developed product with the active ingredient extracted from Cinnamomum cassia Presl., has demonstrated anti-inflammatory and antioxidant activity in vitro and an in vivo protective effect against gastric damage by stimulating mucus secretion. This study compared the efficacy and safety of CKD-495 with Artemisiae argyi folium (AAF) for the treatment of acute and chronic gastritis. AAF, a gastric mucosa protective agent that promotes gastric mucosa regeneration, has been used clinically for about 20 years. METHODS: This phase III multicenter, randomized, double-blind, parallel-group trial (ClinicalTrials.gov; NCT04255589) assigned 242 patients with endoscopically-proven gastric mucosal erosions to receive CKD-495 75 mg (n = 122) or AAF 60 mg (n = 120), respectively, with placebo (for double-blind purposes) 3 times a day for 2 weeks. The primary efficacy endpoint was the erosion improvement rate. Secondary endpoints included erosion cure rates, and improvement rates for edema, redness, hemorrhage, and gastrointestinal (GI) symptoms. Drug-related adverse events were evaluated. RESULTS: The erosion improvement rate was significantly higher in the CKD-495 group than in the AAF group for both the full analysis set (55.9% vs 39.4%, P = .0063) and per-protocol set (54.6% vs 38.2%, P = .0084). In addition, the erosion improvement rate in patients with acute or chronic gastritis showed that the CKD-495 group had better improvement of erosion than the AAF group, especially in patients with chronic gastritis. Analysis of secondary endpoints, which included erosion cure rate and the improvement rates of edema, redness, hemorrhage, and GI symptoms, showed that the CKD-495 group was more effective than the AAF group. There were no significant between-group differences in safety profiles. No serious adverse events or adverse drug reactions occurred. CONCLUSIONS: These results demonstrate that CKD-495 75 mg is superior to AAF 60 mg in terms of the endoscopic improvement rate of erosions in patients with acute or chronic gastritis. This new mucoprotective agent, CKD-495, can be considered the therapy of choice for symptomatic relief and healing of gastritis.

Comparison of endoscopic retrograde cholangiopancreatography outcomes between cap-fitted forward and side viewing endoscopes in patients with Billroth II anastomosis.

BACKGROUND: There have been no previous studies that directly compared outcomes between cap-fitted forward-viewing and side viewing endoscopes (SE). This study aimed to compare the technical success rate and occurrence of adverse events between the side viewing and cap-fitted forward-viewing endoscope (CE) groups among patients with Billroth II anatomy who underwent ERCP. METHODS: The medical records of patients with a previous history of subtotal gastrectomy using Billroth II reconstruction who underwent ERCP at Yeungnam University Hospital between January 2004 and December 2020 were reviewed retrospectively. The patients were divided into CE and SE group. Propensity score matching analysis was performed to minimize selection bias. RESULTS: Propensity score matching resulted in 55 matched pairs for further analysis. Patients' characteristics were comparable in the matched cohorts. Final success rate of selective bile duct cannulation was not significantly different between the SE and CE groups (98.2% vs. 94.5%, p = 0.308). The complete CBD stone removal rate in CBD stone and successful biliary drainage rate in malignant biliary obstruction were not significantly different between the two groups. The rate of total ERCP-related adverse events was higher in the CE group than in the SE group, but the difference was not statistically significant (10.9% vs. 7.3%, p = 0.507). Among adverse events, the rate of post-ERCP pancreatitis showed higher tendency in the CE group than in the SE group (10.9% vs. 5.5%, p = 0.297). CONCLUSION: In conclusion, CE seems to be equally effective as SE for ERCP in patients with Billroth II anatomy. However, attention should be paid to development of post ERCP complications, especially pancreatitis, when performed by CE.

Natural Course of Early Detected Acute Peripancreatic Fluid Collection in Moderately Severe or Severe Acute Pancreatitis.

Background and Objectives: Acute peripancreatic fluid collection (APFC) is an acute local complication of acute pancreatitis (AP) according to the revised Atlanta classification. Sometimes APFC resolves completely, sometimes it changes into a pseudocyst or walled-off necrosis (WON), so called late complications. The aim of this study is to investigate the natural course of APFC detected on early computed tomography (CT) in moderately severe (MSAP) or severe AP (SAP). Materials and Methods: From October 2014 to September 2015, patients with MSAP or SAP were enrolled if there was APFC within 48 h of onset on imaging studies at six medical centers. The status of fluid collection was followed 4-8 weeks after onset. Initial laboratory findings, CT findings and clinical scoring systems were analyzed. Results: A total of 68 patients were enrolled and APFC was completely resolved in 32 (66.7%) patients in the MSAP group and 9 (34.6%) in the SAP group. Patients with a high bedside index for severity in acute pancreatitis (BISAP) score (≥3 points) were common in the SAP group. C-reactive protein (CRP) after 48 h from admission and BUN level were also high in the SAP group. In multivariate analysis, BISAP score (≥3 points), elevation of CRP after 48 h (≥150 mg/L) and nasojejunal feeding after 48 h were risk factors for the development of late complications. Conclusions: Spontaneous resolution of APFC was more common in MSAP group and APFC can be changed to pseudocyst or WON in patients with elevated BISAP score, CRP level after 48 h, and non-improved abdominal pain.

Changes in endoscopic patterns before and during COVID-19 outbreak: Experience at a single tertiary center in Korean.

BACKGROUND: The surge of coronavirus disease 2019 (COVID-19) patients has markedly influenced the treatment policies of tertiary hospitals because of the need to protect medical staff and contain viral transmission, but the impact COVID-19 had on emergency gastrointestinal endoscopies has not been determined. AIM: To compare endoscopic activities and analyze the clinical outcomes of emergency endoscopies performed before and during the COVID-19 outbreak in Daegu, the worst-hit region in South Korea. METHODS: This retrospective cohort study was conducted on patients aged ≥ 18 years that underwent endoscopy from February 18 to March 28, 2020, at a tertiary hospital in Daegu. Demographics, laboratory findings, types and causes of emergency endoscopies, and endoscopic reports were reviewed and compared with those obtained for the same period in 2018 and 2019. RESULTS: From February 18 to March 28, a total of 366 emergent endoscopic procedures were performed: Upper endoscopy (170, 50.6%), endoscopic retrograde cholangiopancreatography (113, 33.6%), and colonoscopy with sigmoidoscopy (53, 15.8%). The numbers of procedures performed in 2018 and 2019 dropped by 48.8% and 54.8%, respectively, compared with those in 2020. During the COVID-19 outbreak, the main indications for endoscopy were melena (36.7%), hematemesis (30.6%), and hematochezia (10.2%). Of the endoscopic abnormalities detected, gastrointestinal bleeding was the most common: 39 cases in 2018, 51 in 2019, and 35 in 2020. CONCLUSION: The impact of COVID-19 is substantial and caused dramatic reductions in endoscopic procedures and changes in patient behaviors. Long-term follow-up studies are required to determine the effects of COVID-19 induced changes in the endoscopy field.

Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study.

Background/Aims: : The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of MucostaⓇ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or MucostaⓇ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; MucostaⓇ, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; MucostaⓇ, n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and MucostaⓇ-treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and MucostaⓇ-treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was -4.01% (95% confidence interval [CI], -13.09% to 5.06%) in the ITT analysis and -4.44% (95% CI, -13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 MucostaⓇ-treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions: The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (MucostaⓇ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Difficult Biliary Cannulation from the Perspective of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: Identifying the Optimal Timing for the Rescue Cannulation Technique.

Background/Aims: Recently, the European Society of Gastrointestinal Endoscopy (ESGE) proposed criteria for "difficult biliary cannulation" during endoscopic retrograde cholangiopancreatography (ERCP). This study aimed to investigate the clinical relevance of the ESGE criteria from the perspective of post-ERCP pancreatitis (PEP). Methods: An ERCP database was prospectively maintained between November 2014 and December 2015 across six teaching hospitals in South Korea. The ESGE criteria (biliary cannulation time, the number of cannulation attempts, and inadvertent pancreatic duct [PD] manipulation) were recorded in this database as well as other technical factors. Logistic regression analysis was used to identify risk factors for PEP. Then, the PEP prediction model was investigated using decision tree analysis. Results: We analyzed 1,067 consecutive patients with naïve papilla. The overall rate of PEP was 6.6%. Multivariate analysis revealed that female sex (odds ratio [OR], 1.860; 95% confidence interval [CI], 1.124 to 3.078), a selective biliary cannulation duration >5 minutes (OR, 3.282; 95% CI, 1.641 to 6.566), and inadvertent PD manipulation (OR, 2.614; 95% CI, 1.480 to 4.617) were significant factors affecting PEP. Decision tree analysis revealed that biliary cannulation time (χ2=49.857, p<0.001) and inadvertent PD manipulation (χ2=8.556, p=0.010) were decisive factors. PEP occurred in 3.9%, 11.8%, and 16.2% of patients with biliary cannulation duration lasting 3 to 5 minutes, >5 minutes, and >5 minutes with inadvertent PD manipulation, respectively. Conclusions: Biliary cannulation time and inadvertent PD manipulation could be relevant indicators of PEP, and 5 minutes might be used as a cutoff value for the implementation of the rescue cannulation technique.

Malignant potential of small pancreatic neuroendocrine neoplasm and its risk factors: A multicenter nationwide study.

BACKGROUND: Pancreatic neuroendocrine neoplasms (PNENs) show heterogeneous biological behavior, and most small PNENs show indolent features. Consequently, selected cases can be considered for observation only, according to the National Comprehensive Cancer Network guideline, however, supporting clinical evidence is lacking. We investigated the clinical course of small PNENs and their risk factors for malignant potential. METHODS: A total of 158 patients with small pathologically confirmed PNENs ≤2 cm in initial imaging were retrospectively enrolled from 14 institutions. The primary outcome was any metastasis or recurrence event during follow-up. RESULTS: The median age was 57 years (range, 22-82 years), and 86 patients (54%) were female. The median tumor size at initial diagnosis was 13 mm (range, 7-20 mm). PNENs were pathologically confirmed by surgery in 137 patients and by EUS-guided fine needle aspiration biopsy (EUS-FNAB) in 21 patients. Eight patients underwent EUS-FNAB followed by surgical resection. The results of WHO grade were available in 150 patients, and revealed 123 grade 1, 25 grade 2, and 2 neuroendocrine carcinomas. A total of 145 patients (92%) underwent surgical resection, and three patients had regional lymph node metastasis. During the entire follow-up of median 45.6 months, 11 metastases or recurrences (7%) occurred. WHO grade 2 (HR 13.97, 95% CI 2.60-75.03, p = 0.002) was the only predictive factor for malignant potential in multivariable analysis. CONCLUSIONS: WHO grade is responsible for the malignant potential of small PNENs ≤2 cm. Thus, EUS-FNAB could be recommended in order to provide early treatment strategies of small PNENs.

Oxaliplatin-induced Sudden Hearing Loss in a Patient with Pancreatic Cancer.

Oxaliplatin is a new generation of platinum derivatives used frequently to treat solid organ malignancies, including colorectal and ovarian cancer. Recently, an oxaliplatin-based chemotherapeutic regimen was adopted for advanced pancreatic cancer. Although oxaliplatin has extensive therapeutic potential, its use can be limited by significant adverse effects, particularly ototoxicity. This paper reports a rare case of irreversible unilateral hearing loss in a 48-year-old female that developed after the intravenous infusion of oxaliplatin during pancreatic cancer treatment. To the best of the authors' knowledge, this is the second reported case of oxaliplatin-related ototoxicity in pancreatic cancer.

Clinical characteristics of coronavirus disease 2019 patients with diarrhea in Daegu.

BACKGROUND/AIMS: Coronavirus disease 2019 (COVID-19) can reportedly cause gastrointestinal symptoms. Therefore, we investigated the clinical characteristics of COVID-19 patients with diarrhea. METHODS: We included 118 COVID-19 patients admitted to a single hospital from February 20 to March 31, 2020. Medical records with clinical characteristics, laboratory data, treatment course, and clinical outcomes were compared based on the presence or absence of diarrhea. Prognostic factors for disease severity and mortality in COVID-19 were also assessed. RESULTS: Among patients, 54 (45.8%) had diarrhea, whereas seven (5.9%) had only diarrhea. The median age of patients with diarrhea was 59 years (44 to 64), and 22 (40.7%) were male. Systemic steroid use, intensive care unit admission, septic shock, and acute respiratory distress syndrome were less frequent in the diarrhea group than in the non-diarrhea group. No significant differences were observed in total hospital stay and mortality between groups. On multivariate analysis, age (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.01 to 1.12; p = 0.044), diabetes (OR, 3.00; 95% CI, 1.25 to 20.47; p = 0.042), and dyspnea (OR, 41.19; 95% CI, 6.60 to 823.16; p < 0.001) were independent risk factors for septic shock. On Cox regression analysis, diabetes (hazard ratio [HR], 4.82; 95% CI, 0.89 to 26.03; p = 0.043) and chronic obstructive pulmonary disease (HR, 16.58; 95% CI, 3.10 to 88.70; p = 0.044) were risk factors for mortality. CONCLUSION: Diarrhea was present in 45.8% of patients and was a common symptom of COVID-19. Although patients with diarrhea showed less severe clinical features, diarrhea was not associated with disease severity or mortality.

Long-term outcomes of acute acalculous cholecystitis treated by non-surgical management.

Although cholecystectomy is generally recommended for acute acalculous cholecystitis (AAC) treatment, non-surgical management can be considered in patients at a high risk for surgery. This study compared outcomes of surgical and non-surgical management and analyzed the long-term outcomes of AAC patients managed non-surgically.We retrospectively analyzed 89 patients diagnosed with AAC between January 1, 2007 and April 30, 2014. These patients were divided into 2 groups: non-surgical (n = 41) and surgical (n = 48). Non-surgical management methods were percutaneous cholecystostomy (PC, n = 14) and antibiotics only (n = 27). The non-surgical group was followed up for >3 years after treatment.The mean age was slightly higher in the non-surgical group than in the surgical group without significant difference. The prevalence of cerebrovascular accident in the non-surgical group was significantly higher than that in the surgical group (26.8% vs 8.3%, P = .020). Mean hospital stay was not statistically different between two groups. The surgical group had a significantly higher incidence of posttreatment complications than the non-surgical group (18.8% vs 2.4%, P = .015). During the mean follow-up of 5.7 years, AAC recurred in 4 (9.8%) patients in the non-surgical group. Three patients underwent cholecystectomy, 1 was treated with antibiotics, and no recurrence-related death occurred. The recurrence rate of AAC was not different between PC and antibiotics only groups (14.3% vs 7.4%, P = .596).Recurrence was observed in 9.8% of AAC patients treated non-surgically and the outcome in the non-surgical group was not inferior to that in the surgical group.

Impact of Hospital Volume and the Experience of Endoscopist on Adverse Events Related to Endoscopic Retrograde Cholangiopancreatography: A Prospective Observational Study.

Background/Aims: Few studies have addressed the relationship between the occurrence of adverse events (AEs) in endoscopic retrograde cholangiopancreatography (ERCP) and hospital case volume or endoscopist's experience with inconsistent results. The aim of our study was to investigate the impact of hospital case volume and endoscopist's experience on the AEs associated with ERCP and to analyze patient- and procedure-related risk factors for post-ERCP AEs. Methods: From January 2015 to December 2015, we prospectively enrolled patients with naïve papilla who underwent ERCP at six centers. Patient- and procedure-related variables were recorded on data collection sheets at the time of and after ERCP. Results: A total of 1,191 patients (median age, 71 years) were consecutively enrolled. The overall success rate of biliary cannulation was 96.6%. Overall, 244 patients (20.5%) experienced post-ERCP AEs, including pancreatitis (9.0%), bleeding (11.8%), perforation (0.4%), cholangitis (1.2%), and others (0.9%). While post-ERCP pancreatitis (PEP) was more common when the procedure was performed by less experienced endoscopists, bleeding was more common in high-volume centers and by less experienced endoscopists. Multivariate analysis showed that a less experience in ERCP was significantly associated with PEP (odds ratio [OR], 1.630; 95% confidence interval [CI], 1.050 to 2.531; p=0.030) and post-ERCP bleeding (OR, 1.439; 95% CI, 1.003 to 2.062; p=0.048). Conclusions: Our study demonstrated that overall AEs following ERCP were associated with the experience of the endoscopist. To minimize post-ERCP AEs, rigorous training with a sufficient case volume is required, and treatment strategies should be modified according to the endoscopist's expertise.

Risk factors of recurrent pancreatitis after first acute pancreatitis attack: a retrospective cohort study.

Background and aims: Few studies have been conducted in Asia on the recurrence of acute pancreatitis (AP). This study was designed to investigate characteristics of the disease to predict recurrence.Methods: We retrospectively analyzed 617 patients that experienced a first AP attack between January 2009 and December 2014. Based on reviews of clinical and follow-up data, we attempted to identify risk factors of recurrence using Cox regression analysis.Results: During a median follow-up of 3.2 years (range 3-72 months), 100(16.2%) of the 617 study subjects experienced one or more episodes of recurrent acute pancreatitis (RAP). Of these 100 patients, 75(75%) experienced one relapse, 12(12%) two relapses, and 13(13%) three or more relapses. The etiologies of RAP were an alcohol (48%), gallstone (31%), idiopathic (14%), and others (7%). Univariate analysis showed that an age of <60 years, male gender, smoking, an alcohol-associated etiology, and a local complication at index admission were significant risk factors of RAP. Cox regression analysis showed that an age of <60 years (HR = 1.602, 95% CI: 1.029-2.493), male gender (HR = 1.927, 95% CI: 1.127-3.295), and the presence of a local complication (HR = 3.334, 95% CI: 2.211-5.026) were significant risk factors of RAP development.Conclusion: A local complication at index admission was found to be the strongest risk factor of RAP, and a male gender and an age of <60 years were significantly associated with RAP. Special attention and close follow-up should be afforded to patients with a local complication at index admission or male patients <60 years old.

Randomised phase 3 trial: tegoprazan, a novel potassium-competitive acid blocker, vs. esomeprazole in patients with erosive oesophagitis.

BACKGROUND: Tegoprazan is a novel potassium-competitive acid blocker that has a fast onset of action and can control gastric pH for a prolonged period, which could offer clinical benefit in acid-related disorders. AIM: To confirm the non-inferiority of tegoprazan to esomeprazole in patients with erosive oesophagitis (EE). METHODS: In this multicentre, randomised, double-blind, parallel-group comparison study, 302 Korean patients with endoscopically confirmed EE (Los Angeles Classification Grades A-D) were randomly allocated to either tegoprazan (50 or 100 mg) or esomeprazole (40 mg) treatment groups for 4 or 8 weeks. The primary endpoint was the cumulative proportion of patients with healed EE confirmed by endoscopy up to 8 weeks from treatment initiation. Symptoms, safety and tolerability were also assessed. RESULTS: The cumulative healing rates at week 8 were 98.9% (91/92), 98.9% (90/91) and 98.9% (87/88) for tegoprazan 50 mg, tegoprazan 100 mg and esomeprazole 40 mg, respectively. Both doses of tegoprazan were non-inferior to esomeprazole 40 mg. The incidence of adverse events was comparable among the groups, and tegoprazan was well-tolerated. CONCLUSION: Once daily administration of tegoprazan 50 or 100 mg showed non-inferior efficacy in healing EE and tolerability to that of esomeprazole 40 mg.

Efficacy of 0.5-L vs 1-L polyethylene glycol containing ascorbic acid as additional colon cleansing methods for inadequate bowel preparation as expected by last stool examination before colonoscopy.

BACKGROUND: No consensus has been reached in patients suspected of having inadequate bowel preparation regarding optimal salvage methods, which negatively affects the efficacy and quality of colonoscopy. The most ideal and reasonable rescue option involves early suspicion and identification of patients with inadequate preparation before sedation, additional oral ingestion of a suitable preparation formulation, and same-day colonoscopy. AIM: To compare 0.5-L and 1-L polyethylene glycol containing ascorbic acid (PEG + Asc) as additional bowel cleansing methods after a 2-L split-dose PEG + Asc regimen in patients with expected inadequate bowel preparation before colonoscopy. METHODS: Individuals with expected inadequate bowel preparation based on last stool form, such as turbid liquid, particulate liquid, or liquid with small amounts of feces, were randomized to either a 0.5-L PEG + Asc group or a 1-L PEG + Asc group. The primary endpoint was bowel preparation as assessed using the Aronchick bowel preparation scale (ABPS) and Boston bowel preparation scale (BBPS) scores. The secondary endpoints were cecal intubation time, withdrawal time, polyp detection rate (PDR), adenoma detection rate (ADR), individual compliance with additional PEG + Asc, and patient satisfaction. RESULTS: Initially, 98 patients were included, but 8 were later excluded due to withdrawal of consent to participate in the study. Adequate bowel preparation (as assessed by ABPS) was observed in 80.9% (38/47) of subjects in the 0.5-L group and in 88.4% (38/43) of subjects in the 1-L group (P = 0.617). Mean total BBPS was 6.7 points in the 0.5-L group and 7.0 points in the 1-L group (P = 0.458). ADRs and PDRs were similar in the two groups, and cecal intubation and withdrawal times were not significantly different. However, mean patient satisfaction score was significantly higher in the 0.5-L group (P = 0.041). CONCLUSION: The bowel cleaning efficacy of additional 0.5-L PEG + Asc was not inferior to that of 1-L PEG + Asc. Additional 0.5-L PEG + Asc is worthwhile when inadequate bowel preparation is expected before colonoscopy.

Is endoscopic sphincterotomy beneficial for the treatment of acute gallstone pancreatitis with small bile duct stone?

BACKGROUND: Acute gallstone pancreatitis occurs when a gallstone is impacted at the ampulla of Vater. The role of endoscopic retrograde cholangiopancreatography in the treatment of small choledocholithiasis in these patients is uncertain. The aim of this study was to compare outcomes of expectant management with endoscopic sphincterotomy for the treatment of small choledocholithiasis (≤5 mm) in patients with acute gallstone pancreatitis. PATIENTS AND METHODS: Of the 258 patients admitted for acute gallstone pancreatitis from January 2010 to December 2014, 174 patients with small choledocholithiasis were reviewed retrospectively. Patients with coexisting acute cholangitis and/or pancreatobiliary malignancy were excluded. They were divided into an endoscopic sphincterotomy group (n=64) and an expectant management group (n=110). Severity index and outcomes of pancreatitis, complications, and overall mortality were compared. RESULTS: Age and sex were not significantly different between the two groups. The mean Ranson, acute physiology and chronic health evaluation-II, and bedside index of severity in acute pancreatitis scores were not significantly different between the two groups. The computed tomography severity index score was significantly higher in the expectant management group than in the endoscopic sphincterotomy group (1.6±1.1 vs. 1.0±0.9, P<0.001). Duration of hospitalization, time for normalization of the white blood cell count, and time for oral feeding were similar in both groups. There was no significant difference between two groups in the incidence of development of pseudocyst or walled-off necrosis. In addition, no difference was observed in the rate of recurrence of acute pancreatitis and readmission because of recurrent choledocholithiasis. CONCLUSION: Expectant management seems to be effective for the treatment of patients with acute gallstone pancreatitis and size of bile duct stones equal to or less than 5 mm.

On-demand versus half-dose continuous therapy with esomeprazole for maintenance treatment of gastroesophageal reflux disease: A randomized comparative study.

BACKGROUND AND AIMS: No consensus has been established regarding optimal long-term maintenance therapy in symptomatic gastroesophageal reflux disease (GERD). The aim of this study was to compare the efficacies of on-demand and continuous therapy with esomeprazole as maintenance treatments for GERD. METHODS: Patients with upper gastrointestinal (GI) endoscopy-proven GERD who received initial proton pump inhibitor (PPI) therapy for 8 weeks were randomized to an on-demand group (esomeprazole 40 mg) or a continuous group (esomeprazole 20 mg). Intensities and frequencies of heartburn and acid regurgitation were assessed using a 6-point Likert scale (0 = no symptoms; 5 = very severe symptoms) and a 6-point frequency scale (0 = none; 5 = symptoms for > 5 days per week) at baseline (start of maintenance treatment) and after 12 weeks of treatment. Alleviation of symptoms was quantified using percentages of patients with a Likert scale or frequency scale of 0 or 1. RESULTS: Of the 88 patients enrolled, 8 patients were excluded due to follow-up loss in early period of this study, and finally, 39 in the on-demand group and 41 in the continuous group were analyzed. No significant intergroup difference was found between Likert scale or frequency scale of heartburn or regurgitation at baseline. Percentages of symptom alleviations in the on-demand and continuous groups for intensity of heartburn were 56.4%/48.8% at baseline (P = .523) and 82.1%/87.8% at 12 weeks (P = .471), for frequency of heartburn were 61.5%/46.3% at baseline (P = .173) and 76.9%/87.8% at 12 weeks (P = .200), for intensity of regurgitation was 53.8%/43.9% at baseline (P = .374) and 82.1%/87.8% at 12 weeks (P = .471), and for frequency of regurgitation was 61.5%/56.1% at the baseline (P = .621) and 82.1%/82.9% at 12 weeks (P = .918), respectively. Furthermore, no significant intergroup difference was found for convenience of medication or subjective satisfaction. CONCLUSIONS: Intensities and frequencies of heartburn and regurgitation responded well to maintenance treatment in patients in the on-demand and continuous groups. On-demand therapy with esomeprazole 40 mg appears to be sufficient for maintenance treatment in GERD patients.