Although some studies have shown that the quantitative, immunochemical fecal occult blood test (FOBT) (qFIT) has better performance characteristics than the standard guaiac-based FOBT (GT) for ...identifying advanced colorectal neoplasia (ACRN), there is limited information on test performance of these tests in average-risk populations.
Seven hundred seventy consecutive average-risk patients from four centers who were undergoing screening colonoscopy also provided stool samples. Stool specimens from three consecutive bowel movements were applied to a hemoccult II test card (Beckman Coulter, Fullerton, CA) and OC-SENSA MICRO (Eiken Chemical, Tokyo, Japan) sampling probes at the same time. We measured the diagnostic value of the qFIT for detecting an ACRN by using three criteria: sensitivity, specificity, and likelihood ratios. A receiver operating characteristic curve for determining the qFIT cutoff values and the number of tests that best discriminated between ACRNs and other findings were determined.
Seventy-eight ACRNs were identified during colonoscopy. At all hemoglobin thresholds, the sensitivity of the qFIT was higher than that of the GT for cancer or ACRN. The sensitivity and specificity of the GT for detecting advanced adenomas, cancer, and ACRNs were 13.6%/92.4%, 30.8%/92.4%, and 16.7%/92.9%, respectively. Using the 100 ng/ml cut point and three-sample qFIT results, the sensitivity and specificity of the qFIT for detecting advanced adenomas, cancer, and ACRNs were 33.9%/90.6%, 84.6%/89.8%, and 43.7%/91.9%, respectively. The area under the curve for cancer indicated that using either 2 or 3 tests provided the best discrimination for cancer.
The qFIT provides a higher sensitivity for detecting ACRN and cancer than the GT, and has an acceptable specificity that significantly reduces the need for colonoscopic evaluation in the screened population.
Background The technique of endoscopic submucosal dissection (ESD) was introduced to be able to obtain en bloc specimens of large early GI neoplasms. The drawback of ESD is its technical difficulty, ...which, consequently, is associated with a higher rate of complication and which requires advanced endoscopic techniques and a long procedure time. Objective To assess the therapeutic outcome of ESD by expert endoscopists who have at least 3 years' experience of EMR in Korea. Design A retrospective, multicenter study. Patients From January 2006 to June 2007, 1000 early gastric cancers in 952 patients (502 men, 450 women; mean age 62.1 years, range 43-90 years) were treated by using ESD at 6 Korean ESD study group (KESG)–related university hospitals in Korea. Intervention We performed ESD procedures with typical sequences (marking, incision, and submucosal dissection). Main Outcome Measurements The rate of en bloc resection, incidence of complication, and length of procedure. Predetermined factors (various endoscopic and final pathologic features) for these outcomes. Results The rates of en bloc resection, complete en bloc resection, vertical incomplete resection, and piecemeal resection were 95.3%, 87.7%, 1.8%, and 4.1%, respectively. The rates of delayed bleeding, significant bleeding, perforation, and surgery related to complication were 15.6%, 0.6%, 1.2%, and 0.2%, respectively. The mean procedure time was 47.8 ± 38.3 minutes. The rates of en bloc resection differed significantly in relation to the location of the lesions (upper portion vs middle portion vs lower portion of the stomach, 88.6% vs 95.2% vs 96.0%, respectively; P = .02), presence of a scar (no vs yes, 96.0% vs 89.5%, respectively; P = .002), and histologic type (low-grade adenoma vs high-grade adenoma vs differentiated early gastric cancer vs undifferentiated early gastric cancer, 95.8% vs 94.6% vs 96.2% vs 83.8%, respectively; P = .007). The rates of delayed bleeding differed significantly in relation to location (upper portion vs lower portion of the stomach, 28.6% vs 13.8%, respectively; P = .003), the size of the tumor (>40 mm vs <20 mm, 28.6% vs 13.7%, respectively; P = .009), recurrent lesion (29.4% vs 15.1%, respectively; P = .024), and macroscopic type (flat vs elevated, 18.8% vs 12.4%, respectively; P = .047). Factors related to the longer procedure time were location (upper portion vs lower portion of the stomach, 64.8 vs 44.1 minutes, respectively; P < .001), the size of the tumor (>40 mm vs < 20 mm, 67.1 vs 42.0 minutes, respectively; P < .001), the presence of ulcer (54.6 vs 46.8 minutes; P < .045), and the presence of a scar (69.2 vs 45.0 minutes; P < .001). Conclusions ESD is an effective and safe therapy in the management of early gastric neoplasms. Endoscopists have to accept the need for advanced endoscopic techniques for performing ESD in the case of large lesions, scar lesions, undifferentiated cancers, or for the lesions in the upper portion of the stomach. Endoscopists require more experience to decrease complications in patients who have a large or recurrent lesion in the upper portion of the stomach; these lesions also take more time to complete the ESD procedure.
Background No reported prospective, randomized study has evaluated the impact of an endoscopy nurse participating as a second observer during colonoscopy. Objective To determine whether the ...participation of an endoscopy nurse enhanced the polyp detection rate (PDR) and adenoma detection rate (ADR) during screening colonoscopy. Design Multicenter, prospective, randomized study. Setting Academic hospitals. Patients A total of 844 consecutive patients undergoing screening colonoscopy. Interventions Single observation by colonoscopist or dual observation by colonoscopist and endoscopy nurse during colonoscope withdrawal. Main Outcome Measurements PDR and ADR. Results No significant difference in patient demographic data, adequacy of bowel preparation, or mean withdrawal time was observed between the 2 groups. In total, 1153 polyps, including 762 adenomas, were detected in 791 patients. Seven nonpolypoid, depressed neoplastic lesions (0-IIc or combined types) were only detected in the dual observation group. A multivariate analysis revealed that experienced (≥2 years) endoscopy nurse participation significantly increased the PDR and ADR compared with those in the single observation group by a colonoscopist alone (adjusted odds ratio OR 1.58 95% CI, 1.07-2.32; adjusted OR 1.47 95% CI, 1.01-2.12, respectively). Additionally, the PDR was significantly higher in the dual-observation group with fellows (<500 colonoscopies) and an experienced endoscopy nurse versus that in the single observation group (adjusted OR 2.07 95% CI, 1.15-3.74). There was no significant benefit of experienced nurse participation in the subgroup with experienced colonoscopists. Limitations Absence of colonoscopist blinding. Conclusions Experienced endoscopy nurse participation increased the PDR and ADR during screening colonoscopy. However, the benefit of participation by experienced nurses appears to be exclusively with inexperienced colonoscopists. (Clinical trial registration number: NCT01124266 .)
Background and Aim
A biosimilar of infliximab, CT‐P13 (Remsima®) has the potential to reduce treatment costs and enhance access to biological therapy for inflammatory bowel disease (IBD) patients. ...However, long‐term clinical data on its use for IBD treatment are currently sparse. We aimed to investigate the long‐term efficacy and safety of CT‐P13 therapy in a large, real‐life IBD cohort.
Methods
A total of 368 IBD patients (227 with Crohn's disease CD and 141 with ulcerative colitis UC) treated with CT‐P13 at 16 referral hospitals in Korea between July 2012 and December 2017 were retrospectively analyzed.
Results
The cumulative retention rates at years 1, 3, and 5 were 86.1%, 68.5%, and 58.7% and 69.7%, 46.0%, and 26.7% in anti‐tumor necrosis factor (TNF)‐naïve CD and UC patients, respectively. The clinical response and remission rates at week 14 and at years 1, 3, and 5 were 94.3%, 92.7%, 76.8%, and 17.6% and 78.6%, 82.4%, 72.2%, and 17.6% in anti‐TNF‐naïve CD and 85.6%, 80.0%, 55.2%, and 6.7% and 42.6%, 59.8%, 44.2%, and 6.7% in anti‐TNF‐naïve UC patients, respectively. Among patients who switched from the biologic originator to CT‐P13, the cumulative retention rates at years 1, 3, and 5 were 88.5%, 66.1%, and 44.8% in CD, and 73.9%, 42.5%, and 42.5% in UC patients, respectively. Significant improvements in disease activity scores were accompanied by marked reductions in inflammatory marker levels, and no unexpected adverse events including death or malignancy occurred during the study period.
Conclusions
Long‐term treatment with CT‐P13 is effective in inducing and maintaining disease improvement and is well‐tolerated in patients with IBD. CT‐P13 may be a promising treatment option for IBD.
Background/Aims
Infliximab is currently used for the treatment of moderate‐to‐severe ulcerative colitis (UC) with an inadequate response to conventional agents. The efficacy and safety of infliximab ...in Korean patients with UC were assessed.
Methods
This was a retrospective multicenter study including all adult patients who received at least one infliximab infusion for UC. Short‐ and long‐term clinical outcomes and adverse events of infliximab therapy were evaluated, and predictors of response were identified.
Results
A total of 134 UC patients were included. The indications for infliximab therapy were acute severe UC in 28%, steroid‐dependency in 38%, and steroid‐refractoriness in 33%, respectively. The rates of clinical response and remission were 87% and 45% at week 8. In multivariate analysis, we found significant predictors of clinical remission at week 8: immunomodulator‐naïve (odds ratio OR = 4.89, 95% confidence interval CI: 1.44–16.66, P = 0.01), hemoglobin ≥ 11.5 g/dL (OR = 4.47, 95% CI: 1.48–13.45, P = 0.008), C‐reactive protein ≥ 3 mg/dL (OR = 4.77, 95% CI: 1.43–15.94, P = 0.01), and response at week 2 (OR = 20.54, 95% CI: 2.40–175.71, P = 0.006). Long‐term clinical response and remission rates were 71% and 52%, respectively, and mucosal healing was the only factor influencing long‐term response. Adverse events related to infliximab occurred in 15% of patients, and most of them were mild and transient.
Conclusions
Infliximab is effective and safe in the treatment of active UC in Korea. No history of previous immunomodulator use and high baseline C‐reactive protein are independent predictors of good response.
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 Digital chromoendoscopy (DCE) has the potential for the in vivo optical diagnosis of colon polyps. However, no comparison of different DCE technologies currently exists. Objective To ...compare the diagnostic efficacies of narrow-band imaging (NBI) with those of I-Scan for the real-time histological prediction of diminutive colonic polyps (DCPs) (≤5 mm) by using the simple unified endoscopic classification. Design Prospective cohort study. Setting Academic hospital. Patients In total, 296 DCPs from 142 patients undergoing screening or surveillance colonoscopy were assessed. Interventions All DCPs detected during withdrawal were evaluated for the surface details by using high-definition white-light colonoscopy, and thereafter by using DCE (NBI or I-Scan) without optical magnification. The histology of all polyps was predicted in real-time and confirmed through the evaluation of biopsy or polypectomy specimens. Main Outcome Measurements Diagnostic efficacies of NBI and I-Scan. Results NBI and I-Scan displayed a significantly higher sensitivity and improved accuracy compared with high-definition white-light colonoscopy for the prediction of adenomas ( P < .05). No significant differences were evident between the NBI and I-Scan (sensitivity, 88.8% vs 94.6%; specificity, 86.8% vs 86.4%; accuracy, 87.8% vs 90.7%, respectively; P > .05). Additionally, substantial levels of intra- and interobserver agreement between the NBI and I-Scan were measured (κ values >0.7). Limitations No randomized or crossover design. Conclusions NBI and I-Scan displayed a similar efficacy for the real-time histological prediction of DCPs. The simple unified endoscopic classification can be used for the interpretation of DCE, regardless of the type of technology. (Clinical trial registration number: NCT1133041 .)
To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea.
This post-marketing study included patients with active moderate-to-severe ...Crohn's disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission.
No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not.
CT-P13 was well tolerated and efficacious in patients with IBD.
Background and Aim
Although differences in genetic susceptibility and the clinical features of Crohn's disease (CD) have been reported between Asian and Caucasian patients, the disease course and ...predictors of CD in Asians remains poorly defined. The study therefore aimed to investigate factors predictive of the clinical outcomes of patients with CD in a Korean population.
Methods
This retrospective multicenter cohort study included 728 Korean CD patients from 13 university hospitals. The first CD‐related surgery or need for immunosuppressive or biological agents were regarded as the clinical outcomes of interest.
Results
A total of 126 (17.3%) CD patients underwent CD‐related surgery, while 473 (65.0%) and 196 (26.9%) were prescribed thiopurine drugs and infliximab, respectively. Multivariate Cox regression analysis identified current (hazard ratio HR = 1.86; P = 0.018) and former smoking habits (HR = 1.78; P = 0.049), stricturing (HR = 2.24; P < 0.001), and penetrating disease behavior at diagnosis (HR = 3.07; P < 0.001) as independent predictors associated with the first CD‐related surgery. With respect to immunosuppressive and biological agents, younger age (< 40 years) (HR = 2.17; P < 0.001 and HR = 2.10; P = 0.006, respectively), ileal involvement (HR = 1.36; P = 0.035 and HR = 2.17; P = 0.006, respectively), and perianal disease (HR = 1.42; P = 0.001 and HR = 1.38; P = 0.038, respectively) at diagnosis were significant predictors for the need of these medications.
Conclusions
In Korean patients with CD, stricturing, penetrating disease behavior, and smoking habits at the time of diagnosis are independent predictors for CD‐related surgery. It was also identified that younger age (< 40 years), ileal involvement, and perianal disease at diagnosis are predictive of a need for immunosuppressive or biological agents.
Background There are few controlled studies on balanced propofol sedation (BPS) for therapeutic endoscopy. Objective To compare the safety and efficacy of BPS (propofol in combination with midazolam ...and meperidine) with conventional sedation (midazolam and meperidine) in patients undergoing therapeutic endoscopic procedures. Design Prospective, randomized, single-blinded study. Setting Tertiary-care referral center. Patients This study involved 222 consecutive patients undergoing therapeutic EGD or ERCP from July 2009 to March 2010. Intervention Conventional sedation or BPS by trained registered nurses under endoscopist supervision. Main Outcome Measurements Rates of sedation-related cardiopulmonary complications and interruption of the procedures, procedure-related times, and assessments of health care providers (endoscopists and sedation nurses) and patients. Results There were no significant differences between the BPS and conventional groups in the rates of cardiopulmonary complications (8.8% 9/102 vs 5.8% 6/104, respectively) and transient interruption of procedures (2.9% 3/102 vs 0% 0/104, respectively). No patient required assisted ventilation or premature termination of a procedure. BPS provided significantly higher health care provider satisfaction (mean ± SD 10-cm visual analog scale VAS score) compared with conventional sedation (endoscopists: 7.57 ± 2.61 vs 6.55 ± 2.99, respectively; P = .011; sedation nurses: 7.86 ± 2.31 vs 6.67 ± 2.90, respectively; P = .001). Patient cooperation was significantly better in the BPS group (VAS; endoscopists: 7.24 ± 2.97 vs 6.27 ± 3.09, P = .024; sedation nurses: 7.75 ± 2.30 vs 6.54 ± 2.99, P = .001). Limitations Single-center and single-blinded study. Conclusion Compared with conventional sedation, BPS provides higher health care provider satisfaction, better patient cooperation, and similar adverse event profiles in patients undergoing therapeutic endoscopic procedures.
