Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

PURPOSE: Debates exist regarding the effectiveness of adjuvant chemotherapy for stage II colon cancer. This study aimed to investigate the current status of adjuvant chemotherapy and its impact on survival for Korean stage II colon cancer patients by analyzing the National Quality Assessment data. MATERIALS AND METHODS: A total of 7,880 patientswho underwent curative resection for stage II colon adenocarcinoma between January 2011 andDecember 2014 in Koreawere selected randomly as evaluation subjects for the quality assessment. The factors that influenced overall survival were identified. The high-risk group was defined as having at least one of the following: perforation/obstruction, lymph node harvest less than 12, lymphovascular/perineural invasion, positive resection margin, poor differentiation, or pathologic T4 stage. RESULTS: The median follow-up period was 38 months (range, 1 to 63 months). Chemotherapy was a favorable prognostic factor for either the high- (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.38 to 0.59; p < 0.001) or low-risk group (HR, 0.74; 95% CI, 0.61 to 0.89; p=0.002) in multivariate analysis. This was also the case in patients over 70 years of age. The hazard ratio was significantly increased as the number of involved risk factors was increased in patients who didn’t receive chemotherapy. Adding oxaliplatin showed no difference in survival (HR, 1.36; 95% CI, 0.91 to 2.03; p=0.132). CONCLUSION: Adjuvant chemotherapy can be recommended for stage II colon cancer patients, but the addition of oxaliplatin to the regimen must be selective.
Adenocarcinoma ; Chemotherapy, Adjuvant* ; Colon* ; Colonic Neoplasms* ; Drug Therapy ; Follow-Up Studies ; Humans ; Lymph Nodes ; Multivariate Analysis ; Risk Factors ; Treatment Outcome

PURPOSE: This study was designed to evaluate the efficacy of a fat clearing technique for accurate nodal staging of rectal cancer patients after preoperative chemoradiotherapy (CRT). METHODS: A total of 19 patients with rectal cancer within 10 cm from anal verge were divided into two groups: non-CRT group (n = 10) and CRT group (n = 9). For pathologic assessment, lymph node (LN) harvest was performed using conventional manual dissection followed by a fat clearing technique. RESULTS: A median of 3.0 additional LNs in non-CRT group and 3.8 LNs in CRT group were identified by the fat clearing technique. When subanalysis was performed in patients with fewer than 12 retrieved LNs, a median of 4.0 extra LNs in non-CRT group and 3.5 extra LNs in CRT group were identified after the fat clearing technique. None of additionally identified nodes were metastatic. In both groups, the median size of retrieved LNs following the fat clearing technique was smaller than that obtained by manual dissection (2.0 mm vs. 3.0 mm, P < 0.001). CONCLUSION: The fat clearing technique allowed detection of additional LNs that were missed by the manual method, but these detected LNs were not proven to be metastatic.
Chemoradiotherapy ; Humans ; Lymph Nodes ; Rectal Neoplasms

BACKGROUND: We investigated the prognostic significance of tumor regression grade (TRG) after preoperative chemoradiation therapy (preop-CRT) for locally advanced rectal cancer especially in the patients without lymph node metastasis. METHODS: One-hundred seventy-eight patients who had cT3/4 tumors were given 5,040 cGy preoperative radiation with 5-fluorouracil/leucovorin chemotherapy. A total mesorectal excision was performed 4-6 weeks after preop-CRT. TRG was defined as follows: grade 1 as no cancer cells remaining; grade 2 as cancer cells outgrown by fibrosis; grade 3 as a minimal presence or absence of regression. The prognostic significance of TRG in comparison with histopathologic staging was analyzed. RESULTS: Seventeen patients (9.6%) showed TRG1. TRG was found to be significantly associated with cancer-specific survival (CSS; P = 0.001) and local recurrence (P = 0.039) in the univariate study, but not in the multivariate analysis. The ypN stage was the strongest prognostic factor in the multivariate analysis. Subgroup analysis revealed TRG to be an independent prognostic factor for the CSS of ypN0 patients (P = 0.031). TRG had a stronger impact on the CSS of ypN (-) patients (P = 0.002) than on that of ypN (+) patients (P = 0.521). In ypT2N0 and ypT3N0, CSS was better for TRG2 than for TRG3 (P = 0.041, P = 0.048), and in ypN (-) and TRG2 tumors, CSS was better for ypT1-2 than for ypT3-4 (P = 0.034). CONCLUSION: TRG was found to be the strongest prognostic factor in patients without lymph node metastasis (ypN0), and different survival was observed according to TRG among patients with a specific histopathologic stage. Thus, TRG may provide an accurate prediction of prognosis and may be used for f tailoring treatment for patients without lymph node metastasis.
Humans ; Lymph Nodes ; Multivariate Analysis ; Neoplasm Metastasis ; Prognosis ; Rectal Neoplasms ; Recurrence

Villous adenomas of the stomach are rare, although they more frequently occur in the colon and rectum. Clinical symptoms are similar to gastric polyps, but acute or chronic bleeding with anemia occurs frequently. The size of tumors varies between 4 and 6 cm, and the malignant potential is greater when the tumor is larger. Complete resection with surgery or endoscopic resection is the treatment of choice. Endoscopic findings revealed a dome-like or pedunculated appearance. Microscopically, the tumor was composed of long fronds and papillations covered by columnar epithelia with a reduced number of goblet cells. We report a case of polyps with chronic intermittent and acute bleeding for 6 months, which was alleviated by endoscopic mucosal resection and was confirmed as a villous adenoma.
Adenoma ; Adenoma, Villous ; Anemia ; Colon ; Gastrointestinal Hemorrhage ; Goblet Cells ; Hemorrhage ; Polyps ; Rectum ; Stomach

Propofol is widely used for sedation during endoscopy. Hemodynamic compromise and respiratory depression might occur under propofol sedation, whereas anaphylaxis is rare. We recently experienced this rare side effect. A 71-year-old woman suffering from substernal chest discomfort underwent endoscopic examination under propofol sedation. She denied any history of allergic reaction to drugs or foods such as beans and eggs. After completion of the endoscopic examination, she developed a whole-body rash with pruritus and edema of her face, including the eyelids and lips. Hypotension was seen on physical examination, and her oxygen saturation was decreased on pulse oximetry. She recovered completely after treatment with epinephrine, an antihistamine, and steroids, with supportive care. Anaphylaxis to propofol is a rare side effect, and prompt treatment is mandatory when it develops.
Aged ; Anaphylaxis ; Conscious Sedation ; Edema ; Eggs ; Endoscopy ; Epinephrine ; Exanthema ; Eyelids ; Fabaceae ; Female ; Hemodynamics ; Humans ; Hypersensitivity ; Hypotension ; Lip ; Ovum ; Oximetry ; Oxygen ; Physical Examination ; Propofol ; Pruritus ; Respiratory Insufficiency ; Steroids ; Stress, Psychological ; Thorax

PURPOSE: The use of prophylactic antibiotics in elective colorectal surgery is essential. Although postoperative prophylactic antibiotics are recommended within 24 hr, the optimal duration of the use of prophylactic antibiotics after colorectal surgery has not yet been fully proven in Korea. The aim of this study was to compare infectious outcomes in elective colorectal cancer surgery between postoperative 3-day antibiotic therapy and 5-day therapy. METHODS: We conducted a multicenter, randomized trial of a 3-day use vs. a 5-day use of the second-generation cephalosporin cefotetan after elective colorectal surgery. The main outcome measures were the incidences of surgical site infection and all other infectious complications within 21 days after surgery. RESULTS: A total of 306 patients were enrolled. Fifty-one patients were excluded because they received additional surgery or dropped out during the study. Two-hundred fifty-five patients were analyzed in this study. The two groups were similar in terms of demographics, ASA score, tumor location, tumor stage, surgical approach (conventional open vs. laparoscopy-assisted vs. robotic-assisted), and type of operation. The incidences of surgical site infection were not significantly different between the 3-day use group (4/130 or 3.1%) and the 5-day use group (3/125 or 2.4%) (P=1.000). Incidences of overall infectious diseases did not differ significantly between the two groups. Postoperatively, both groups had similar values in their white blood cell count, absolute neutrophil count, and C-reactive protein levels. However, the number of patients is small to draw a definite conclusion in this study. CONCLUSION: Three-day cefotetan administration may be not inferior in preventing surgical site infection compared to 5-day antibiotic administration. However, further studies with a large number of patients are needed before a definite conclusion can be drawn.
Anti-Bacterial Agents ; C-Reactive Protein ; Cefotetan ; Colorectal Neoplasms ; Colorectal Surgery ; Communicable Diseases ; Demography ; Humans ; Incidence ; Korea ; Leukocyte Count ; Neutrophils ; Outcome Assessment (Health Care) ; Prospective Studies

PURPOSE: The role of local excision in treating rectal cancer patients continues to be controversial. The aim of this study was to evaluate the long-term oncological results of local excision for early rectal adenocarcinomas and review the outcomes of salvage therapy on rectal cancer patients. MATERIALS AND METHODS: Between March 1992 and September 2005, 35 consecutive patients with early-stage primary rectal adenocarcinomas were treated by local excision with curative intent. The mean tumor distance from the anal verge was 5 cm (range, 1-10 cm). RESULTS: The median follow-up was 66 months (range, 17-161 months). Pathological examination revealed 23 cases of T1 and 12 cases of T2. Recurrence had developed in 10 patients (6 local recurrences, 4 systemic recurrences). Purely extrapelvic recurrence was observed in only two (5.7%) patients. Of the eight recurrent patients with surgical salvage, five survived with no evidence of disease at the time of this analysis. The 5-year local recurrence-free and disease-free survival rates were 79.6% and 67.9%, respectively. CONCLUSION: Local excision alone of early-staged rectal adenocarcinomas, even in the ideal candidate, is followed by a relatively higher local recurrence rate than previously reported and may not be a valid modality. Either the use of adjuvant therapy with local excision, even in patients with T1 lesions or the use of preoperative therapy followed by local excision has good promise.
Adenocarcinoma/*pathology/surgery ; Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Recurrence, Local/epidemiology/*pathology/surgery ; Rectal Neoplasms/*pathology/surgery ; Retrospective Studies ; Risk Factors ; Salvage Therapy ; Time Factors ; Treatment Outcome