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.

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.

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.

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.

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.

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.

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.

Colonoscopy scheduling influences adenoma and polyp detection rates.

BACKGROUND/AIMS: Because colonoscopy can be a technically challenging procedure, endoscopist fatigue, which usually increases as day progresses, may impact procedural performance. The aim of this study was to determine the influence of colonoscopy scheduling on adenoma and polyp detection rates (ADR and PDR, respectively). METHODOLOGY: This was a retrospective study of data prospectively collected on 1,293 consecutive, asymptomatic, average-risk patients. Three separate timing variables were assessed, as follows: morning vs. afternoon procedures; start times throughout the day; and four groups by matching each subsequent passing hour in the morning and afternoon sessions. RESULTS: 420 (32%) were performed in the morning and 881 (68%) were performed in the afternoon. There was a significantly higher ADR and PDR in the morning colonoscopies compared to the afternoon colonoscopies (42.3% vs. 34.7% [po=0.008] and 52.5% vs. 46.3% [p=0.038], respectively). Based on multivariable analysis, afternoon colonoscopies and colonoscopies performed during 4th hour of session were significantly associated with a decreased ADR (OR, 0.739 [0.576-0.949], p=0.018; and OR, 0.651 [0.443-0.975], p=0.029). CONCLUSIONS: Colonoscopies scheduled in the morning have a significantly higher ADR and PDR as compared to colonoscopies scheduled in the afternoon. Also,colonoscopies performed during 4th hour of the session were associated with decreased ADR.

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.

Optimal duration of proton pump inhibitor in the treatment of endoscopic submucosal dissection-induced ulcers: a retrospective analysis and prospective validation study.

BACKGROUND: The optimal duration of proton pump inhibitor (PPI) use in the treatment of endoscopic submucosal dissection (ESD)-induced ulcers has not been well defined. AIMS: The aim of study was to determine the optimal duration of PPI treatment for ESD-induced gastric ulcers. METHODS: A total of 333 patients who underwent ESD were included in this retrospective analysis and prospective randomized validation. Medical records and endoscopic images for the 221 patients in our ESD-database were reviewed retrospectively. Based on the results of the retrospective analysis, 112 patients with ESD-induced ulcers over 40 mm were randomly assigned to two groups (4- or 8-week course of Lansoprazole 30 mg). Main outcome measurements were to assess the healing-related factors of post-ESD ulcers (retrospective analysis) and to compare complete mucosal healing rate in large (≥ 40 mm) ESD-induced ulcers according to the duration of PPI treatment (prospective validation). RESULTS: Multivariate logistic regression from a retrospective analysis showed that a duration of PPI treatment <8 weeks and a post-ESD ulcer ≥ 40 mm in size were associated with incomplete healing. In a prospective validation, the rate of complete healing in the 8-week PPI group was significantly higher than that of the 4-week PPI group for a large (≥ 40 mm) ESD-induced ulcer at 8 weeks follow-up (83.3 vs. 42.6%, P < 0.01). CONCLUSIONS: The optimal duration of PPI treatment varies based on the initial ulcer size. Patients with an ESD-induced ulcer over 40 mm should be treated with an 8-week course of PPIs.

Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures.

BACKGROUND: Prolonged or complex endoscopic procedures are frequently performed under deep sedation. However, no studies of therapeutic ERCP have yet compared the use of balanced propofol sedation (BPS) to propofol alone, titrated to moderate levels of sedation. AIM: This prospective, randomized, double-blind study was planned to compare the sedation efficacy and safety of BPS (propofol in combination with midazolam and fentanyl) and propofol monosedation in therapeutic ERCP and EUS. METHODS: BPS, or propofol monosedation titrated to a moderate level of sedation, was performed by trained registered nurses under endoscopist supervision. The main outcome measurements included sedation efficacy focusing on recovery time, sedation safety, endoscopic procedure outcomes, and complications. RESULTS: There were no significant differences in sedation efficacy, safety, procedure outcomes, and complications, with the exception of recovery time. Mean recovery time (standard deviation) was 18.37 (7.86) min in BPS and 13.4 (6.24) min in propofol monosedation (P < 0.001). In a safety analysis, cardiopulmonary complication rates related to BPS and propofol monosedation were 7.8 % (8/102) and 9.6 % (10/104), respectively (P = 0.652). No patient required assisted ventilation or permanent termination of a procedure in either group. Technical success of the endoscopic procedures was 96.3 and 97.2 %, respectively (P = 0.701). Endoscopic procedure-related complications and outcomes did not differ depending on sedation procedure. CONCLUSIONS: Propofol monosedation by trained, registered sedation nurses under supervision resulted in a more rapid recovery time than BPS. There were no differences in the sedation safety, endoscopic procedure outcomes, and complications between BPS and propofol monosedation.

Trainees' adenoma detection rate is higher if ≥ 10 minutes is spent on withdrawal during colonoscopy.

BACKGROUND: It has been demonstrated that prolonged colonoscopic withdrawal times (WT; >6 min) are beneficial for the adenoma detection rate (ADR) for experienced endoscopists. There are little data, however, to guide the appropriate colonoscopic withdrawal times for trainees. The purpose of this study was to determine whether there is a relationship between WTs and ADR for first-year fellows training in colonoscopy. METHODS: This is a prospective study of first-year gastroenterology fellows at a single academic teaching hospital who documented each colonoscopy with a self-report form over the course of an academic year (March 2010 to February 2011). The internal policy for the trainees was to have at least a 6-min withdrawal time for each colonoscopy. RESULTS: Four first-year fellows in gastroenterology at an academic medical center completed self-reports for 1,210 colonoscopies. Mean WT was 10.2 ± 3.4 min. The aggregate polyp detection rate was 33.2% and the aggregate ADR was 22.3%. For colonoscopies with WT < 10 min, ADR was 9.5%, and for colonoscopies with WT ≥ 10 min, ADR was 32.3% (p < 0.001). When the quality indicator of 25% goal ADR for males and 15% goal ADR for females is applied, this aggregate rate is achieved for both sexes for screening colonoscopies (n = 676) with WT ≥ 10 min. CONCLUSIONS: First-year trainees had a significantly higher ADR if their colonoscopic WT is ≥ 10 min.

Narrow-band imaging versus I-Scan for the real-time histological prediction of diminutive colonic polyps: a prospective comparative study by using the simple unified endoscopic classification.

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.).

Participation by experienced endoscopy nurses increases the detection rate of colon polyps during a screening colonoscopy: a multicenter, prospective, randomized study.

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.

Balanced propofol sedation for therapeutic GI endoscopic procedures: a prospective, randomized study.

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.

Development of a pancreatic tumor animal model and evaluation of NOTES tumor enucleation.

BACKGROUND: Laparoscopic distal pancreatectomy is associated with high morbidity and mortality. NOTES tumor enucleation may provide an alternative to laparoscopic distal pancreatectomy. The goal of this study was to determine the feasibility of NOTES tumor creation and enucleation as a multidisciplinary approach. METHODS: A linear-array endoscopic ultrasound (EUS) endoscope was used to inject a thermosensitive ABA triblock polymer mixed with methylene blue through the stomach wall and into the distal pancreas using a 22-gauge EUS needle. Due to its thermosensitive character, the polymer solidifies in response to body temperature, creating an artificial tumor. Seventeen swine underwent NOTES transgastric pancreatic tumor enucleation. Nine nonsurvival animals were sacrificed immediately after the NOTES procedure, with subsequent necropsy. Eight survival animals were observed for up to 16 days after the procedure, subsequently sacrificed, followed by necropsy. RESULTS: The procedure was performed successfully in all 17 pigs studied, 9/9 nonsurvival (100%) and 8/8 survival (100%) animals, using a pure NOTES approach without any laparoscopic ports. Complications included two esophageal dissections (1 in nonsurvival group, 1 in survival group) caused by the introduction of the endoscopic overtube (2/17, 12%), unrelated to the actual surgical procedure. In the survival animals, there were two small splenic lacerations caused during retraction with the endoscopic forceps, for which hemostasis was achieved prior to closure of the gastrotomy (2/7, 29%). At necropsy of the animals, there was sufficient closure of 15/17 gastrotomy sites (88%). CONCLUSIONS: The creation of artificial pancreatic tumors via EUS guidance is feasible. Pancreatic tumor enucleation using a transgastric NOTES approach is technically feasible and could be an alternative to laparoscopic distal pancreatectomy with further development. Further adoption and adaptation of this technique will require the development of more sophisticated specialized tools to improve the safety profile of the procedure.

Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Periductal hypoechoic sign: an endosonographic finding associated with pancreatic malignancy.

BACKGROUND: Despite advances in imaging, differentiating benign from malignant causes of pancreatic duct dilation is difficult. OBJECTIVE: The aim of our study was to assess the accuracy of the periductal hypoechoic sign (PHS), defined as patchy hypoechoic areas adjacent to a dilated pancreatic duct, for the diagnosis of pancreatic malignancy. DESIGN: Single-center, retrospective analysis. SETTING: Tertiary care university hospital. PATIENTS: All patients who underwent EUS from 2006 to 2008 for evaluation of pancreatic pathology were identified. Those with pancreatic duct dilation of 4 mm or more in the head of the pancreas or 3 mm or more in the body or tail were included. Digitally recorded EUS images were analyzed for PHS by 1 endoscopist blinded to final results. The final diagnosis was based on pathology results or clinical follow-up. RESULTS: During the study period, 84 of 427 patients who underwent EUS for pancreas pathology had dilated pancreatic ducts. Of these, 42 patients had benign disease and 42 had pancreatic malignancy. The PHS was noted in 31 (73.8%) of 42 patients with malignancy compared with 6 (14.3%) of 42 patients with benign disease (P < .001). The PHS had a sensitivity of 73.8%, a specificity of 85.7%, and an accuracy of 79.8% for the diagnosis of pancreatic malignancy. After adjusting for age, patients with the PHS were 17 times more likely to have a malignancy (odds ratio 16.66; 95% CI, 5.01-55.44). Pancreatic duct diameter or dilation of both bile and pancreatic ducts were not predictive of malignancy. LIMITATION: A retrospective design. CONCLUSIONS: The PHS was an accurate and independent predictor of pancreatic malignancy in patients with a dilated pancreatic duct.

Efficacy of a prototype endoscope with two deflecting working channels for endoscopic submucosal dissection: a prospective, comparative, ex vivo study.

BACKGROUND: Optimizing the visualization of the cutting line of the submucosal layer is essential to performing an effective and safe endoscopic submucosal dissection (ESD). OBJECTIVE: To evaluate the prototype R-scope compared with a conventional, double-channel endoscope in time required for ESD of mucosal lesions in distinct anatomical locations of the stomach. DESIGN: A prospective, comparative, ex vivo study. INTERVENTION: ESD. MAIN OUTCOME MEASUREMENTS: Procedure time (primary end point measure), specimen size, submucosal injection frequency, en bloc resection rate, and perforation rate (secondary end point measures). RESULTS: In the subgroup of resections in the greater and lesser curvature, the mean (+/- SD) procedure time was significantly less in the R-scope group compared with the conventional endoscope group (8.4 +/- 2.1 minutes vs 11.3 +/- 2.1 minutes, respectively; P = .006), and the mean (+/- SD) submucosal injection frequency was significantly less in the R-scope group compared with the conventional endoscope group (1.9 +/- 0.6 vs 2.5 +/- 0.5, respectively; P = .025). There were no significant differences in procedure time, specimen size, submucosal injection requirements, en bloc resection rate, and perforation rate between the two endoscopic groups of all combined anatomic lesions. LIMITATIONS: Small, ex vivo study. CONCLUSION: ESD by using the R-scope may provide an improved platform for quicker ESD, especially in greater and lesser curvature anatomical lesions of the stomach.

Endoscopic partial resection with the unroofing technique for reliable tissue diagnosis of upper GI subepithelial tumors originating from the muscularis propria on EUS (with video).

BACKGROUND: There is a growing body of evidence that a pathological diagnosis is necessary for small (<3 cm in diameter), asymptomatic, hypoechoic, subepithelial tumors (SETs) originating from the muscularis propria on EUS. However, the diagnostic efficacy of current tissue sampling techniques appears to be limited. OBJECTIVE: To evaluate the diagnostic yield and safety of endoscopic partial resection using the unroofing technique (EPR-UT) in a subset of patients. DESIGN: A prospective case series. SETTING: A single tertiary-care referral center. PATIENTS: Between August 2007 and March 2009, 16 patients with hypoechoic SETs of <3 cm in diameter, originating from the muscularis propria on EUS (14 gastric and 2 esophageal lesions), underwent EPR-UT. INTERVENTIONS: The overlying mucosa was removed by using the unroofing technique using a conventional snare with electrical current to expose the tumor sufficiently. Next, the exposed tumor was partially resected by snaring. MAIN OUTCOME MEASUREMENTS: The diagnostic yield and safety of this method. RESULTS: EPR-UT provided specimens that were sufficient for a diagnosis and the assessment of risk for malignancy in 15 out of 16 cases (diagnostic yield 93.7% [95% CI, 80.4%-100.0%]). The pathological diagnoses were leiomyoma (7 of 15, 46.6%), GI stromal tumor (6 of 15, 40.0%), aberrant pancreas (1 of 15, 6.6%), and well-differentiated neuroendocrine carcinoma (1 of 15, 6.6%). Six cases with GI stromal tumor were classified as very low risk for malignant potential (mitotic index <5/50 high-power fields). Procedural blood oozing was relatively common (9 of 16, 56.0% [95% CI, 33.0%-77.0%]); however, this minor complication was easily controlled by argon plasma coagulation. There were no procedure-related major complications (0 of 16, 0% [95% CI, 0.0%-23.0%]). LIMITATIONS: Single-center, noncomparative study with small sample size. CONCLUSION: EPR-UT appears to be simple, safe, and effective for determining the definite pathological diagnosis and assessing malignant potential of small, hypoechoic SETs originating from the muscularis propria on EUS.