Summary
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.
Background and Aim
Gastrointestinal carcinoid tumors < 10 mm in diameter and limited to the submucosal layer demonstrate a low frequency of lymph node and distant metastasis, and are suitable for ...endoscopic treatment. The aim of this study was to assess the efficacy, safety, and long‐term prognosis of endoscopic resections for the treatment of duodenal carcinoid tumors.
Methods
This study included a total of 41 duodenal carcinoid tumors in 38 patients between January 2006 and December 2011. The indications for endoscopic resection were lesions ≤ 10 mm in diameter, confined to the submucosal layer, and without lymph node or distant metastasis. Endoscopic resection was accomplished using endoscopic mucosal resection (EMR), EMR with a ligation device (EMR‐L), EMR after circumferential precutting, or endoscopic submucosal dissection (ESD).
Results
EMR was performed in 18 tumors, EMR‐L in 16, EMR after circumferential precutting in 3, and ESD in 4. En‐bloc resection was performed in 39 tumors (95%), and endoscopic complete resection was achieved in 40 (98%); pathological complete resection was achieved in 17 tumors (41%). The endoscopic complete resection rate did not differ according to the resection method, but the pathological complete resection rate was higher for ESD than for EMR and EMR‐L. Intraprocedural bleeding was noted in five cases, with no occurrence of perforation. Recurrence was not observed during the mean follow‐up period of 17 months (range 1–53 months).
Conclusion
Endoscopic resection appears to be a safe and effective treatment for duodenal carcinoid tumors measuring ≤ 10 mm in diameter and confined to the submucosal layer.
Background Among the procedure-related factors associated with post-ERCP pancreatitis, selective cannulation of the common bile duct by insertion of a guidewire may be associated with fewer ...complications than conventional methods of cannulation with contrast injection to access the bile duct. However, the results of studies regarding the usefulness of wire-guided cannulation (WGC) are conflicting. Objective This prospective randomized trial was designed to determine whether WGC reduces the rate of post-ERCP pancreatitis. Design A prospective randomized controlled trial. Setting Tertiary-care academic medical center. Patients A total of 300 consecutive patients with native papilla and pancreaticobiliary disease who were candidates for therapeutic ERCP were randomized from June 2006 to May 2007. Interventions WGC without contrast injection or conventional cannulation with contrast injection. Main Outcome Measurements Post-ERCP pancreatitis, risk factors, and procedure-related complications were evaluated prospectively. Results A total of 3 patients (2%) in the WGC group and 17 patients (11.3%) in the conventional group had post-ERCP pancreatitis ( P = .001). Among the cases of acute pancreatitis in the WGC group, 2 patients with suspected sphincter of Oddi dysfunction (SOD) and unintentional main pancreatic duct (PD) guidewire cannulation showed post-ERCP pancreatitis despite the use of WGC. In multivariate analysis, WGC was a protective factor (odds ratio 0.1; 95% CI, 0.024-0.490, P = .004), whereas female sex and SOD were risk factors for post-ERCP pancreatitis. Limitation Our study population was a low-risk cohort. Conclusions WGC is associated with a lower rate of post-ERCP pancreatitis. However, WGC may not prevent post-ERCP pancreatitis in patients with suspected SOD and unintentional PD guidewire cannulation.
Background
The Helicobacter pylori eradication rate has decreased with increasing antibiotic resistance. We conducted a prospective, nationwide, multicenter registry study to monitor the real status ...of H. pylori eradication therapy and to investigate the association between eradication success and antibiotic use density in Korea.
Materials and Methods
We enrolled 9318 patients undergoing H. pylori eradication therapy from 37 hospitals through “on‐line database registry” from October 2010 to July 2015. Demographic data, detection methods, treatment indications, regimens, durations, compliance, adverse events, and eradication results were collected. The use of all commercially available eradication antibiotics was analyzed through the Korean National Health Insurance data of the Health Insurance Review and Assessment Service. The defined daily dose of antibiotics was used to standardize drug use comparisons.
Results
Finally, 6738 patients were analyzed. The overall eradication rate of first‐line therapy was 71.8%. The eradication success rates were 71.7%, 86.9%, and 74.0% for standard triple therapy for 7 days, quadruple therapy, and concomitant therapy, respectively. The eradication success rate in naive patients was higher than that in those who previously underwent H. pylori eradication. Eradication success was significantly associated with younger age, female sex, and high compliance. Regional differences in eradication rates were observed. The yearly use density of clarithromycin increased statistically in seven regions across the country from 2010 to 2015. The yearly use density of amoxicillin in the Gyeongsang and Chungcheong areas was significantly increased (P < .01), whereas that of other macrolides was significantly lower in the Gyeonggi area than in other areas (P = .01). The overall use of eradication antibiotics has increased while the eradication rate steadily decreased for 5 years. However, there was no significant correlation between antibiotic use density and eradication.
Conclusion
There was no relationship between the eradication rate and antibiotic use density in Korea.
Background and Study Aim
Although propofol is widely used for sedation for endoscopic procedures, concerns remain regarding cardiopulmonary adverse events. Etomidate has little effect on the ...cardiovascular and respiratory systems, but patient satisfaction analysis is lacking. We compared the efficacy and safety of balanced propofol and etomidate sedation during advanced endoscopic procedures.
Methods
As a randomized noninferiority trial, balanced endoscopic sedation was achieved using midazolam and fentanyl, and patients were randomly assigned to receive propofol (BPS) or etomidate (BES) as add-on drug. The main outcomes were sedation efficacy measured on a 10-point visual analog scale (VAS) and safety.
Results
In total, 186 patients (94 in the BPS group and 92 in the BES group) were evaluated. BES did not show noninferiority in terms of overall patient satisfaction, with a difference in VAS score of −0.35 (97.5 % confidence interval −1.03 to ∞,
p
= 0.03). Among endoscopists and nurses, BES showed noninferiority to BPS, with differences in VAS scores of 0.06 and 0.08, respectively. Incidence of cardiopulmonary adverse events was lower in the BES group (27.7 versus 14.1 %,
p
= 0.023). Hypoxia occurred in 5.3 and 1.1 % of patients in the BPS and BES group (
p
= 0.211). Myoclonus occurred in 12.1 % (11/92) in the BES group. BES had lower risk of overall cardiopulmonary adverse events (odds ratio 0.401,
p
= 0.018).
Conclusions
BES was not noninferior to BPS in terms of patient satisfaction. However, BES showed better safety outcomes in terms of cardiopulmonary adverse events.
Background: Cold snare polypectomy (CSP) is an established technique for resecting small colorectal polyps without electrical current. This study aimed to compare the clinical effectiveness of ...thin-wire mini-snares and thick-wire mini-snares during CSP for small colorectal polyps. Methods: We prospectively enrolled 120 patients with colon polyps (5-8 mm in diameter) who underwent CSP between July and December 2017. Patients were randomly divided into two groups (thick-snare and thin-snare) according to the thickness of the snares. The complete resection rate (CRR), polyp characteristics, technical factors, and histopathologic features of resected specimens were carefully analysed. Results: In total, 137 eligible polyps were successfully resected using CSP (thin-snare group: n = 66, thick-snare group: n = 71). The location, size, morphology, and histologic findings of the polyps did not show statistically significant differences between the two groups. The CRR (thin-snare: 77.3% vs. thick-snare: 84.5%, P = 0.068), retrieval rate (100% in both groups), and the rates of tissue fly-away (P = 0.069), containing submucosal tissue (7.6% vs. 9.9%, P = 0.637), and intraprocedural or delayed polypectomy bleeding were not significantly different between the two groups. The CRR was significantly lower in sessile serrated lesions than in adenomas (odds ratio, 0.1; 95% confidence interval, 0.12-0.57; P = 0.010). Conclusion: In conclusion, when performing CSP for small polyps, the snare thickness does not seem to have a significant effect on the clinical outcomes, including CRR and the occurrence of complications.
AIM:To investigate the efficacy of premedication with pronase,a proteolytic enzyme,in improving imagequality during magnifying endoscopy.METHODS:The study was of a blinded,randomized,prospective ...design.Patients were assigned to groups administered oral premedication of either pronase and simethicone(Group A)or simethicone alone(Group B).First,the gastric mucosal visibility grade(1-4)was determined during conventional endoscopy,and then a magnifying endoscopic examination was conducted.The quality of images obtained by magnifying endoscopy at the stomach and the esophagus was scored from1 to 3,with a lower score indicating better visibility.The endoscopist used water flushes as needed to obtain satisfactory magnifying endoscopic views.The main study outcomes were the visibility scores during magnifying endoscopy and the number of water flushes.RESULTS:A total of 144 patients were enrolled,and data from 143 patients(M:F=90:53,mean age 57.5 years)were analyzed.The visibility score was significantly higher in the stomach following premedication with pronase(73%with a score of 1 in Group A vs 49%in Group B,P<0.05),but there was no difference in the esophagus visibility scores(67%with a score of 1in Group A vs 58%in Group B).Fewer water flushesmean 0.7±0.9 times(range:0-3 times)in Group A vs 1.9±1.5 times(range:0-6 times)in Group B,P<0.05in the pronase premedication group did not affect the endoscopic procedure timesmean 766 s(range:647-866 s)for Group A vs 760 s(range:678-854 s)for Group B,P=0.88.The total gastric mucosal visibility score was also lower in Group A(4.9±1.5 vs 8.3±1.8in Group B,P<0.01).CONCLUSION:The addition of pronase to simethicone premedication resulted in clearer images during magnifying endoscopy and reduced the need for water flushes.
Papillary adenocarcinoma is classified to differentiated-type gastric cancer and is indicated for endoscopic submucosal dissection. However, due to its rare nature, there are limited studies on it. ...The purpose of this study was to determine the outcome of endoscopic submucosal dissection in patients with papillary-type early gastric cancer and to find the risk factors of lymph node metastasis.
Patients diagnosed with papillary-type early gastric cancer at eight medical centers, who underwent endoscopic submucosal dissection or surgical treatment, were retrospectively reviewed. The clinical results and long-term outcomes of post-endoscopic submucosal dissection were evaluated, and the risk factors of lymph node metastasis in the surgery group were analyzed.
One-hundred and seventy-six patients with papillary-type early gastric cancer were enrolled: 44.9% (n=79) in the surgery group and 55.1% (n=97) in the endoscopic submucosal dissection group. As a result of endoscopic submucosal dissection, the
resection and curative resection rates were 91.8% and 86.6%, respectively. The procedure-related complication rate was 4.1%, and local recurrence occurred in 3.1% of patients. Submucosal invasion (odds ratio, 3.735; 95% confidence interval, 1.026 to 12.177; p=0.047) and lymphovascular invasion (odds ratio, 7.636; 95% confidence interval, 1.730 to 22.857; p=0.004) were the risk factors of lymph node metastasis in papillary-type early gastric cancer patients.
The clinical results of endoscopic submucosal dissection in papillary-type early gastric cancer were relatively favorable, and endoscopic submucosal dissection is considered safe if appropriate indications are confirmed by considering the risk of lymph node metastasis.
Background/Aims
Submucosal injection with indigo carmine mixed solution can improve the delineation of colorectal neoplasia during endoscopic mucosal resection (EMR). Thus, the aim of this study was ...to evaluate the efficacy of submucosal injection with indigo carmine mixed solution during EMR of colorectal neoplasia.
Methods
This was a prospective, randomized, controlled study of a total of 212 neoplastic colon polyps (5–20 mm) subjected to EMR in a single tertiary university hospital. The patients were randomized into two groups according to whether or not indigo carmine mixed solution was used, and the complete resection rate (CRR) after EMR was evaluated.
Results
A total of 212 neoplastic polyps (normal saline group, 115; indigo carmine group, 97) were successfully removed by EMR. There was no significant difference in the CRR (92.8 vs. 89.6%,
p
= 0.414) or macroscopic delineation (86.0 vs. 93.8%,
p
= 0.118) between the two groups. In a separate analysis of sessile serrated adenomas/polyps (SSAs/Ps), macroscopic delineation was better in the indigo carmine group than the normal saline group (87.5 vs. 53.8%), albeit not significantly (
p
= 0.103). In univariate analyses, the CRR was significantly related to polyp location, polyp morphology, macroscopic delineation, and pathologic findings. In a multiple logistic regression analysis, macroscopic delineation (odds ratio (OR), 7.616,
p
= 0.001) and polyp pathology (OR, 8.621;
p
< 0.001) were significantly associated with the CRR.
Conclusions
Submucosal injection with indigo carmine mixed solution did not improve the CRR or macroscopic delineation of EMR of colorectal neoplasias.
Background Various training programs in colonoscopy recommend that trainees should perform at least 100 to 200 procedures to be considered technically competent at diagnostic colonoscopy. Objective ...Our purpose was to determine the adequate level of training for technical competence in screening and diagnostic colonoscopy. Design A prospective multicenter trial. Setting Fifteen tertiary care academic medical centers. Patients Over 8 months we prospectively evaluated the procedures of 24 first-year GI fellows in 15 tertiary care academic medical centers. A total of 4351 colonoscopies were assessed prospectively with variable clinical factors. Intervention Cecal intubation was documented by photographing the identified cecal landmarks, including the appendiceal orifice and the ileocecal valve. Main Outcome Measurements Acquisition of competence (success rate) was evaluated for colonoscopic training on the basis of 2 objective criteria: (1) adjusted completion rate (>90%) and (2) cecal intubation time (<20 minutes). Results The overall success rate was 83.5% (3635/4351). The mean cecal intubation time was 9.23 ± 4.63 minutes. The success rate significantly improved and reached the requisite standard of competence after 150 procedures (71.5%, 82.6%, 91.3%, 94.4%, 98.4%, and 98.7%, respectively, for every 50 consecutive blocks). The polyp detection rate did not improve significantly during the 8 months and was not correlated with the learning curve. In addition, mean time to cecal intubation decreased significantly, from 11.16 to 8.39 minutes, after 150 procedures. Logistic regression analysis found that prolonged cecal intubation was caused by the following factors: elderly patients, female sex, low body mass index, poor bowel preparation, poor American Society of Anesthesiologists status, abdominal pain as an indication, instructor's supervision, and low case volume. Limitations We did not record final pathologic reports of detected polyps and withdrawal time. Conclusions Competence in technically efficient screening and diagnostic colonoscopy generally requires experience with more than 150 cases. Also, factors associated with prolonged cecal intubation for typical trainees did not differ from those for experienced colonoscopists.
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