Long-term efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: A retrospective multicenter study.

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.

Three-year colonoscopy surveillance after polypectomy in Korea: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter prospective study.

BACKGROUND/AIMS: Colonoscopic surveillance is currently recommended after polypectomy owing to the risk of newly developed colonic neoplasia. However, few studies have investigated colonoscopy surveillance in Asia. This multicenter and prospective study was undertaken to assess the incidence of advanced adenoma based on baseline adenoma findings at 3 years after colonoscopic polypectomy. METHODS: A total of 1,323 patients undergoing colonoscopic polypectomy were prospectively assigned to 3-year colonoscopy surveillance at 11 tertiary endoscopic centers. Relative risks for advanced adenoma after 3 years were calculated according to baseline adenoma characteristics. RESULTS: Among 1,323 patients enrolled, 387 patients (29.3%) were followed up, and the mean follow-up interval was 31.0±9.8 months. The percentage of patients with advanced adenoma on baseline colonoscopy was higher in the surveillance group compared to the non-surveillance group (34.4% vs. 25.7%). Advanced adenoma recurrence was observed in 17 patients (4.4%) at follow-up. The risk of advanced adenoma recurrence was 2 times greater in patients with baseline advanced adenoma than in those with baseline non-advanced adenoma, though the difference was not statistically significant (6.8% [9/133] vs. 3.1% [8/254], P=0.09). Advanced adenoma recurrence was observed only in males and in subjects aged ≥50 years. In contrast, adenoma recurrence was observed in 187 patients (48.3%) at follow-up. Male sex, older age (≥50 years), and multiple adenomas (≥3) at baseline were independent risk factors for adenoma recurrence. CONCLUSIONS: A colonoscopy surveillance interval of 3 years in patients with baseline advanced adenoma can be considered appropriate.

Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea.

OBJECTIVE: To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea. METHODS: 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. RESULTS: 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. CONCLUSION: CT-P13 was well tolerated and efficacious in patients with IBD.

High-risk metachronous polyps are more frequent in patients with traditional serrated adenomas than in patients with conventional adenomas: a multicenter prospective study.

BACKGROUND AND AIMS: Although the malignant progression of serrated polyps has been clearly documented, the malignant potential of the traditional serrated adenoma (TSA) subtype has not been established. We compared the prevalence of metachronous polyps in surveillance colonoscopies between patients with TSA and those with conventional adenomas (CAs). METHODS: Four hundred twenty patients were diagnosed with TSAs by current diagnostic criteria at 10 tertiary care university hospitals in Korea from January 2003 to December 2005; 186 patients who received surveillance colonoscopy after removal of initial polyps were enrolled. During the same time period, 372 age- and sex-matched patients diagnosed with CAs were used as a control group. RESULTS: TSA patients had a significantly higher recurrence rate of colorectal polyps compared with CA patients (66.1% vs 43.5%, respectively). TSA patients had a greater number (3 vs 2) and larger size (8.6 ± 5.7 vs 6.3 ± 5.2 mm) of recurrent polyps compared with CA patients. TSA patients also had a higher rate of CA (54.8% vs 37.9%), serrated adenoma (14.0% vs. 0.8%), and hyperplastic polyp (33.3% vs. 13.7%) recurrence compared with CA patients. TSA patients had significantly greater odds of having a recurrent high-risk polyp than CA patients (odds ratio, 2.37; 95% confidence interval, 1.55-3.63). CONCLUSIONS: In comparison with patients with CAs, patients with TSAs have a higher metachronous occurrence rate of all polyp subtypes including CAs, serrated adenomas, and hyperplastic polyps. Moreover, the presence of TSAs is an independent predictor of a high-risk polyp occurrence.

Sodium Picosulfate with Magnesium Citrate (SPMC) Plus Laxative Is a Good Alternative to Conventional Large Volume Polyethylene Glycol in Bowel Preparation: A Multicenter Randomized Single-Blinded Trial.

BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.

Long-term clinical outcomes of korean patient with Crohn's disease following early use of infliximab.

BACKGROUND/AIMS: Several recent studies have reported that the early use of infliximab (IFX) improves the prognosis of Crohn's disease (CD). However, no data are available from Asian populations, as the forementioned studies have all been conducted in Western countries. The aim of the current study was to evaluate the impact of early use of IFX on the prognosis of Korean patients with CD. METHODS: Patients with a diagnosis of CD established between July 1987 and January 2012 were investigated in 12 university hospitals in Korea. Because insurance coverage for IFX treatment began in August 2005, patients were assigned to either of 2 groups based on diagnosis date. The first group included patients diagnosed from July 1987 to December 2005, and the second from January 2006 to January 2012. We compared the cumulative probabilities of operation and reoperation between the two groups using the Kaplan-Meier method and a log-rank test. RESULTS: Of the 721 patients investigated, 443 (61.4%) comprized the second group. Although the cumulative probabilities of immunosuppressant (P<0.001) and IFX use (P<0.001) after diagnosis were significantly higher in the second group, there were no significant differences in cumulative probabilities of operation (P=0.905) or reoperation (P=0.418) between two groups. CONCLUSIONS: The early use of IFX did not reduce CD-related surgery requirements in Korean patients with CD. These study results suggest that the early use of IFX may have little impact on the clinical outcome of CD in Korean patients in the setting of a conventional step-up algorithm.

The effect of infliximab on patients with ulcerative colitis in Korea.

BACKGROUND/AIMS: Infliximab was introduced recently as a rescue therapy for ulcerative colitis (UC) patients refractory to conventional treatments such as therapy with 5-amiono salicylic acids (5-ASA), immune modulators, and corticosteroids. However, there is insufficient data about its efficacy and safety in Korea. METHODS: From 7 tertiary referral hospitals, 33 patients who were treated with infliximab for moderate to severe (Mayo score 6-12) UC refractory to conventional treatment were recruited to this study. Clinical remission was defined as a total Mayo score of 2 or lower and every subscore less than 2. Partial response was defined as a decrease of Mayo score at least 3 points from baseline. RESULTS: Twenty-three patients (69.7%) showed clinical remission and 29 patients (87.8%) showed partial response in the observation period. When the remission and non-remission groups were compared in univariate analysis, only a higher total Mayo score at base line (11.0±0.9 vs. 9.9±1.5; P=0.04) was related to remission. The remission maintenance rate decreased with time in the Kaplan-Meier analysis. Two patients experienced re-remission after the first remission followed by aggravation during infliximab treatment. Three patients stopped infliximab treatment owing to adverse events including rhabdomyolysis, pneumonia, and fever of unknown origin. CONCLUSIONS: If there is no choice except surgery for UC patients refractory to conventional treatment, infliximab is an effective and relatively safe treatment option for these patients in Korea.

Comparison of endoscopic band ligation and endoclip closure of colonic perforation: technical feasibility and efficacy in an ex vivo pig model.

BACKGROUND AND AIM: Recent reports have indicated several instances of successful treatment of bowel perforation by using endoscopic band ligation (EBL) when treatment with endoclipping is unsuccessful, but this salvage method has not been investigated in any prospective model. Herein we aimed to compare the technical feasibility and efficacy of EBL and endoclip use in intraluminal closure of colon perforation, in an ex vivo model. METHODS: Standardized colonic perforations were created using fresh porcine colon and subsequently closed by full-thickness interrupted sutures, endoclip (QuickClip2(TM)), or EBL. Each closure site was tested with compressed air by using a digital pressure monitor for evaluating leak pressure. RESULTS: No significant differences were noted between the endoclip and EBL in leak pressures. Mean (± SD) pressures for air leakage from the perforations closed using the different devices were as follows: normal colon samples, 52.0 ± 13.2 mmHg; perforations closed with hand-sewn sutures, 32.3 ± 8.3 mmHg; perforations closed with endoclipping, 53.5 ± 22.7 mmHg; and perforations closed with EBL, 50.4 ± 12.5 mmHg. Time taken for closure by EBL was significantly less than that for closure by endoclipping (3.2 ± 1.7 min vs 6.8 ± 1.3 min, P < 0.01). Further, the number of devices used to achieve complete closure in the EBL group was lower than that with endoclipping (1.6 ± 0.5 vs 3.7 ± 0.8, P < 0.01). CONCLUSION: Endoluminal closure of a 1.5-cm colon perforation with EBL decreased procedure time and was not inferior in leak pressure compared with endoclipping in this ex vivo porcine model.

[Usefulness of polyp and adenoma detection rate in the proximal and distal colon].

BACKGROUND/AIMS: The polyp detection rate (PDR) has been suggested as a surrogate for adenoma detection rate (ADR). The purpose of this study was to determine the level of agreement between PDR and ADR in the proximal and distal colon. METHODS: A total of 1,937 consecutive, asymptomatic individuals aged 40 years and older who underwent colonoscopies at six academic teaching hospitals in Korea were included in this study. PDR and ADR were calculated for each colonic segment. PDR was compared with ADR in the proximal and distal colon. RESULTS: During 1,937 colonoscopies, 1,862 polyps were removed; 1,421 (76%) were adenomas. The PDR and ADR in the proximal colon was 25.8% and 22.8%, respectively (kappa value=0.917, p=0.26), and that in the distal colon was 28.9% and 22.2%, respectively (p<0.001). There was a strong correlation between PDR and ADR in the proximal colon, but diverged in sigmoid colon and rectum. CONCLUSIONS: PDR and ADR correlate well in the proximal colon, but not in the distal colon, especially sigmoid and rectum. PDR should be measured for each colonic segment when using PDR as a surrogate for ADR. PDR is a valid proxy for ADR in the proximal colon.

Clinical features and predictors of clinical outcomes in Korean patients with Crohn's disease: a Korean association for the study of intestinal diseases multicenter study.

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.

Patients with Crohn's disease on anti-tumor necrosis factor therapy are at significant risk of inadequate response to the 23-valent pneumococcal polysaccharide vaccine.

BACKGROUND/AIMS: The effect of immunosuppressants on the efficacy of a variety of vaccines is a controversial issue in patients with inflammatory bowel disease (IBD). In this study we determined whether specific immunosuppressants impair the serological response to the standard 23-valent pneumococcal polysaccharide vaccine (PPSV23) in a large cohort of patients with Crohn's disease (CD). METHODS: This was a multi-center, prospective observational study of adult patients with CD at 15 academic teaching hospitals in Korea. The study population received one intramuscular injection of PPSV23. Anti-pneumococcal IgG antibody titers were measured by immunoassay prior to and 4weeks after vaccination. All vaccination-related adverse events and the effect of the vaccine on disease activity were also evaluated. RESULTS: The overall serological response rate was 67.5% (133/197). The serological response rate was significantly lower in patients on anti-tumor necrosis factor (anti-TNF) therapy (50.0% on anti-TNF alone; 58.0% on anti-TNF combined with an immunomodulator, IM) than patients on 5-aminosalicylate (78.4%; all P-values vs. 5-aminosalicylate<0.05); 45.6% (41/90) of patients on anti-TNF therapy were not protected against PPSV23. IM did not affect the immunologic response to the vaccine. Female gender and anti-TNF therapy were significant predictors of non-response to the vaccine (odds ratio [OR] 2.316, P=0.015; OR 2.582, P=0.048, respectively). Vaccination was generally safe and tolerated by all patients. CONCLUSIONS: Patients with CD on anti-TNF therapy are at significant risk of an inadequate response to PPSV23. The pneumococcal vaccination strategy should be optimized for patients with CD on anti-TNF therapy.

Pathological Predictors for Defining a Therapeutic Strategy for Early Colon Cancer after Endoscopic Resection: Multicenter Retrospective Analysis from Surgically Resected Specimens.

BACKGROUND/AIMS: For the possibility of regional lymph node metastasis (LNM), early colon cancer (ECC) is a boundary lesion between endoscopic resection and surgery. The aim of study is to clarify risk factors for LNM and to determine therapeutic strategy after endoscopic resection in patients with ECC. METHODOLOGY: The histopathology of patients with ECC underwent surgery with LN dissection in 8 university hospitals were reviewed by experienced pathologist blinded to LN status. RESULTS: In total, 370 patients (107 with mucosal cancer, 263 with submucosal invasive colorectal carcinoma [SICC]) were enrolled. Excluding mucosal cancer, the LNM rate was 11.8% (31/263, including 15.4% [8/52] with pedunculated SICC [P-SICC] and 10.9% [23/211] with non-pedunculated SICC [NP-SICC]). Multivariate analysis showed that tumor sprouting (P < 0.001; odds ratio [OR], 8.83; 95% confidence interval [CI], 3.04-25.69), submucosal invasion depth (SM depth) > 2000 µm (P = 0.024; OR, 3.68; 95% CI, 1.19-11.37), and lymphatic invasion (P = 0.022; OR, 3.48; 95% CI, 1.19-10.13) were related to LNM. All LNMs with SM depth < 2000 µm showed tumor sprouting without lymphatic invasion. CONCLUSIONS: Significant risk factors for predicting LNM in patients with SICC were tumor sprouting, SM depth > 2000 µm, and lymphatic invasion.

Seasonal variation in months of birth and symptom flares in Korean patients with inflammatory bowel disease.

BACKGROUND/AIMS: Seasonal variation may influence the development and exacerbation of inflammatory bowel disease (IBD). However, most epidemiologic studies on this topic have been conducted in Western countries. The purpose of this study was to determine whether birth dates and symptom flares follow a seasonal pattern in Korean patients with IBD. METHODS: Patients with a diagnosis of IBD established between January 2003 and December 2010 were investigated at six university hospitals in Korea. The expected births and flares, with a uniform distribution during the year and considering differences in the number of days in the months of 1 year, were calculated. RESULTS: A total of 411 patients with ulcerative colitis (UC) and 316 patients with Crohn disease (CD) were included in the study. Birth during the winter period, and especially in January and February, was associated with an increased risk of IBD, especially in UC patients. The symptom flares of CD patients occurred most frequently in the spring, with a nadir in the autumn. However, no disease flare seasonality was noted for UC patients. CONCLUSIONS: Our data suggest that seasonally varying environmental factors during pregnancy and the postpartum period are associated with a susceptibility to IBD later in life and that exacerbations of CD are influenced by seasonal factors.

A clear liquid diet is not mandatory for polyethylene glycol-based bowel preparation for afternoon colonoscopy in healthy outpatients.

BACKGROUND/AIMS: A dietary regimen consisting of a clear liquid diet (CLD) for at least 24 hours is recommended for colonoscopy preparation. However, this requirement results in problems in patient compliance with bowel preparation. The aim of this study was to evaluate the efficacy of a CLD compared with a regular diet (RD) for colonoscopy preparation using a polyethylene glycol (PEG) solution. METHODS: This was a multicenter, randomized, investigator-blind prospective study. A total of 801 healthy outpatients undergoing afternoon colonoscopy were randomized to either a CLD or RD in addition to a 4 L PEG regimen. RESULTS: The quality of bowel cleansing was not different between the CLD and RD groups in terms of the proportion with excellent or good preparation. In addition, no significant differences were observed between the two groups for polyp and adenoma detection rates and overall adverse events. Good compliance with bowel preparation was higher in the RD group than in the CLD group. CONCLUSIONS: A CLD for a full day prior to colonoscopy should not be mandatory for PEG-based bowel preparation. Dietary education concerning the avoidance of high-fiber foods for 3 days before colonoscopy is sufficient, at least for healthy outpatients.

Endoscopic Removal of a Proximally Migrated Metal Stent during Balloon Sweeping after Stent Trimming.

Placement of a self-expanding metal stent (SEMS) is an effective method for palliation of a malignant biliary obstruction. However, metal stents can cause various complications, including stent migration. Distally migrated metal stents, particularly covered SEMS, can be removed successfully in most cases. Stent trimming using argon plasma coagulation may be helpful in difficult cases despite conventional methods. However, no serious complications related to the trimming or remnant stent removal method have been reported due to the limited number of cases. In particular, proximal migration of a remnant fragmented metal stent after stent trimming followed by balloon sweeping has not been reported. We report an unusual case of proximal migration of a remnant metal stent during balloon sweeping following stent trimming by argon plasma coagulation. The remnant metal stent was successfully removed with rotation technique using a basket and revised endoscopically.

Efficacy, safety, and predictors of response to infliximab therapy for ulcerative colitis: a Korean multicenter retrospective study.

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.

Clinical significance of the first surveillance colonoscopy after endoscopic early colorectal cancer removal.

BACKGROUND/AIMS: We investigated the clinical significance of the first surveillance colonoscopy after endoscopic cancer removal. METHODOLOGY: We conducted a retrospective cohort study at a single center. Patients diagnosed with early colon cancer after endoscopic removal (index colonoscopy) and who underwent surveillance colonoscopy within 1 year were enrolled. All visible lesions were removed during index colonoscopy. Polyps newly detected at surveillance colonoscopy considered as lesions missed during index colonoscopy were analyzed. We investigated risk factors for missing an advanced lesion. RESULTS: In total, 139 patients diagnosed with early colorectal cancer were enrolled. Overall 774 lesions were removed during index colonoscopy and an additional 222 lesions were newly detected at the surveillance colonoscopy. The lesion miss rate during index colonoscopy was 22.3%. The miss rates for advanced adenoma and cancer were 11.4% and 3.6%, respectively. Total number of polyps during index colonoscopy was an associated risk factor for missing an advanced lesion (odds ratio 1.176, 95% interval 1.062-1.303). CONCLUSIONS: Synchronous advanced neoplasms can be missed during endoscopic removal in patients with early colorectal cancer. Clinical significance of the first surveillance colonoscopy after endoscopic early colorectal cancer removal is detection of missed synchronous advanced neoplasms during index colonoscopy.

Quantifying exposure to diagnostic radiation and factors associated with exposure to high levels of radiation in Korean patients with inflammatory bowel disease.

BACKGROUND: Several recent studies have revealed that diagnostic imaging can result in exposure to potentially harmful levels of ionizing radiation in patients with inflammatory bowel disease (IBD). However, these studies have been conducted exclusively in Western countries, and no data are available in Asian populations. The aim of this study was to estimate the diagnostic radiation exposure in Korean patients with IBD and to determine the factors associated with high radiation exposure. METHODS: Patients with an established diagnosis of IBD between July 1987 and January 2012 were investigated in 13 university hospitals in Korea. The cumulative effective dose (CED) was calculated retrospectively from standard tables. RESULTS: A total of 777 patients with Crohn's disease (CD) and 1422 patients with ulcerative colitis (UC) were included in the study. The mean CED for CD and UC were 53.6 and 16.4 mSv, respectively (P < 0.001). CTof CD and UC accounted for 81.6% and 71.2% of total effective dose, respectively. Importantly, 34.7% of patients with CD and 8.4% of patients with UC were exposed to high levels of radiation (CED > 50 mSv) (P < 0.001). High radiation exposure was associated with long disease duration, ileocolonic disease, upper gastrointestinal tract involvement, surgical intervention, hospitalization, and the requirement for oral steroids in CD, and with surgical intervention, hospitalization, and the requirement for infliximab in UC. CONCLUSIONS: A substantial proportion of patients with IBD, especially patients with CD, were exposed to significantly harmful amounts of diagnostic radiation, mainly as a result of CT examination. Given that IBD is a life-long illness, strategies to reduce radiation exposure from diagnostic imaging need to be considered.

Human applications of submucosal endoscopy under conscious sedation for pure natural orifice transluminal endoscopic surgery.

BACKGROUND: The submucosal endoscopy provide not only a reliable methods of access and closure for peritoneoscopy, but also an endoscopic working space for full-thickness resection. The aim of this study was to report the clinical outcome of submucosal endoscopy for pure natural orifice transluminal endoscopic surgery. METHODS: We prospectively evaluated 10 patients who received submucosal endoscopies. The indications of submucosal endoscopy were transgastric peritoneoscopy (TGP) and endoscopic full-thickness resection (EFTR) of a gastric subepithelial tumor. All procedures were performed with a standard gastroscope under conscious sedation with the balanced propofol method in the endoscopic unit. After a 40 mm submucosal tunnel was created using an endoscopic submucosal dissection technique, (1) in TGP, balloon dilation of a serosal puncture and intraperitoneal exploration was performed; (2) in EFTR, a full-thickness incision and snaring resection was performed. Closure of the mucosal incision was performed by endoclips. RESULTS: All cases were technically feasible. The mean times for creating the submucosal tunnel, main procedure (peritoneal exploration or resection), and closure were acceptable (10.44 ± 2.42 minutes, 18.80 ± 9.41 minutes, and 5.63 ± 2.17 minutes, respectively). The mean hospital stay was 3.8 ± 1.48 days. All TGPs were diagnostic (4 peritoneal carcinomatosis and 1 tuberculosis). En bloc and complete resections were possible in all EFTRs (3 gastrointestinal stromal tumors and 2 schwannomas; mean tumor size, 20.8 ± 3.27 mm). There were no procedure-related complications, such as significant bleeding or peritonitis. CONCLUSIONS: Human applications of submucosal endoscopy under conscious sedation for pure NOTES were feasible and safe.

Rescue endoscopic band ligation of iatrogenic gastric perforations following failed endoclip closure.

Iatrogenic gastric perforation is one of the most serious complications during therapeutic endoscopy, despite significant advances in endoscopic techniques and devices. This case study evaluated the clinical efficacy and safety of the rescue endoscopic band ligation (EBL) technique in iatrogenic gastric wall perforation following the failure of primary endoclip closure. Five patients were enrolled in this study. These patients underwent emergency endoscopy following the onset of acute gastric wall perforation during endoscopic procedures. The outcome measurements were primary technical success and immediate or delayed procedure-related complications. Successful endoscopic closure using band ligation was reported in all patients, with no complication occurring. We conclude that EBL may be a feasible and safe alternate technique for the management of acute gastric perforation, especially in cases where closure is difficult with endoclips.