Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial.

BACKGROUND: Endoluminal radiofrequency ablation (RFA) has been promoted as palliative treatment for patients with cholangiocarcinoma (CCA) and pancreatic ductal adenocarcinoma (PDAC) in order to improve biliary drainage and eventually prolong survival. No high level evidence is, however, available on this technique. DESIGN: In this randomised controlled study, we compared endoluminal RFA plus stenting with stenting alone (control group) in patients with malignant biliary obstruction; metal stents were primarily placed. Primary outcome was overall survival; secondary outcomes were stent patency, quality of life and adverse events. In a superiority design, survival was assumed to be doubled by RFA as compared with 6.4 months in the control group (n=280). RESULTS: A total of 161 patients (male:female 90:71, mean age 71±9 years) were randomised before recruitment was terminated for futility after an interim analysis. Eighty-five patients had CCA (73 hilar, 12 distal) and 76 had pancreatic cancer. There was no difference in survival in both subgroups: for patients with CCA, median survival was 10.5 months (95% CI 6.7 to 18.3) in the RFA group vs 10.6 months (95% CI 9.0 to 24.8), p=0.58)) in the control group. In the subgroup with pancreatic cancer, median survival was 6.4 months (95% CI 4.3 to 9.7) for the RFA vs 7.7 months (95% CI 5.6 to 11.3), p=0.73) for the control group. No benefit was seen in the RFA group with regard to stent patency (at 12 months 40% vs 36% in CCA and 66% vs 65% in PDAC), and quality of life was unchanged by either treatment and comparable between the groups. Adverse events occurred in seven patients in each groups. CONCLUSION: A combination of endoluminal RFA and stenting was not superior to stenting alone in prolonging survival or improving stent patency in patients with malignant biliary obstruction. TRIAL REGISTRATION NUMBER: NCT03166436.

EUS-guided transluminal drainage using lumen-apposing metal stents with or without coaxial plastic stents for treatment of walled-off necrotizing pancreatitis: a prospective bicentric randomized controlled trial.

BACKGROUND AND AIMS: Lumen-apposing metal stents (LAMSs) have proven to be effective for drainage of pancreatic walled-off necrosis (WON), although associated adverse events (AEs) have been reported. Anchoring coaxial double-pigtail plastic stents (DPSs) within LAMSs have been proposed to prevent LAMS-related AEs but have not been assessed in prospective studies. We aimed to evaluate the utility of such measures with a randomized controlled trial. METHODS: We randomly assigned consecutive patients with WON indications for drainage to EUS-guided transluminal drainage using LAMSs with (group A) or without (group B) DPSs. All LAMSs were to be removed after 3 weeks had elapsed from the index procedure with a preceding CT to decide whether additional steps needed to be taken (eg, transluminal necrosectomy or placing transluminal plastic stents in patients with incomplete resolution of WON). The main outcomes were failure of the index method, defined as necessity of reintervention (endoscopic, percutaneous, or surgical) before LAMS removal because of LAMS-related AEs and/or clinical deterioration; AE rates; and mortality with the LAMS in place. Variables were evaluated using the Mann-Whitney U test, χ2 test, or Fisher exact test as appropriate. P < .05 was considered significant. RESULTS: Sixty-seven patients (37.3% women; mean age, 54 ± 14.4 years) underwent LAMS placement with (n = 34) or without (n = 33) DPS placement in 2 tertiary centers. Baseline characteristics including demographics, etiology, comorbidity, and clinical presentation (sterile vs infected necrosis) were comparable between both groups. The technical success rate in placing LAMSs and DPSs was 100%. The global rate of AEs was significantly lower in group A versus group B (20.7% vs 51.5%, respectively; P = .008). Stent occlusion was the most frequently observed AE (14.7% vs 36.3%, P = .042). Failure of the index method was lower in group A versus group B (29.4% vs 48.5%, respectively; P = .109); however, the difference did not achieve statistical significance. The same applied to the mortality rate with LAMSs in place (2.9% vs 12.1%, P = .197). CONCLUSIONS: The addition of a coaxial DPS within a LAMS was associated with a significantly lower global rate of AEs and stent occlusion rate in EUS-guided drainage of WON. (Clinical trial registration number: NCT03923686.).

Motorized spiral enteroscopy - a prospective analysis of 82 procedures at a single tertiary center.

INTRODUCTION: Motorized spiral enteroscopy (MSE) is a promising novel deep enteroscopy technique. The purpose of our study was to evaluate efficiency and safety of MSE in a single tertiary endoscopy center. METHODS: We prospectively evaluated all consecutive patients undergoing MSE in our endoscopy unit from June 2019 through June 2022. Main outcomes were technical success rate, proportion of procedures with sufficient depth of insertion, success rate of total enteroscopy, diagnostic yield and complication rate. RESULTS: A total of 82 examinations in 62 patients (56% males, mean age 58 ± 18 years) were performed, 56 from antegrade and 26 from retrograde approach. Technical success rate was 94% (77/82) and in 89% (72/82) of cases, depth of insertion was considered sufficient. Total enteroscopy was indicated in 19 patients and it was achieved in 16 of them (84%), either by antegrade in 4 or by combined approach in 12 cases. Diagnostic yield was 81%. Lesion of the small bowel was found in 43 of patients. Mean insertion time was 40 for antegrade and 44 min for retrograde procedures, respectively. Complications occurred in 3% (2/62) of patients. One patient suffered from mild acute pancreatitis after total enteroscopy and there was one intussusception of the sigmoid during endoscope withdrawal resolved by parallel colonoscope insertion. CONCLUSION: In our series of 82 procedures in 62 patients examined by MSE during a three-year period, we show high technical success rate (94%), diagnostic yield (81%) and low complication rate (3%).

Percutaneous endoscopic cecostomy for management of Ogilvie's syndrome: a case series and literature review with an update on current guidelines (with video).

INTRODUCTION: Percutaneous endoscopic cecostomy (PEC) is a viable treatment option for patients with persistent or recurrent acute colonic pseudo-obstruction (ACPO; Ogilvie's syndrome). It should be generally considered in patients that are refractory to pharmacologic and endoscopic decompression, especially those not amenable to surgical intervention due to an increased perioperative risk. Physicians are rather unfamiliar with this approach given the limited number of reports in the literature and paucity of guideline resources, although guidelines concerning ACPO and covering the role of endoscopy were recently published by three major expert societies, all within the last 2 years. PATIENTS AND METHODS: We retrospectively identified three consecutive patients who underwent PEC placement at a Czech tertiary referral center between May 2018 and December 2021: all for recurrent ACPO. In addition, we summarized the current guidelines in order to present the latest knowledge related both to the procedure and management approach in patients with ACPO. RESULTS: The placement of PEC was successful and resulted in clinical improvement in all cases without any adverse events. CONCLUSION: The results of our experience are in line with previous reports and suggest that PEC may become a very useful tool in the armamentarium of modalities utilized to treat ACPO. Furthermore, the availability of guideline resources now offers comprehensive guidance for informed decision-making and the procedural aspects.

News in gastroenterology, hepatology and digestive endoscopy.

Gastroenterology, hepatology and digestive endoscopy are rapidly evolving disciplines with significant advances in the diagnostics and treatment in the entire gastrointestinal tract. The aim of our article was to summarize new perspectives on relevant situations in gastroenterology and hepatology like acute pancreatitis, functional dyspepsia, rational indication of proton pump inhibitors, inflammatory bowel diseases (IBD), cholestatic liver diseases, alcohol induced hepatitis, non-alcoholic fatty live disease (NAFLD) and patophysiology of bilirubin and bile acids. Digestive endoscopy represents an interventional part of gastroenterology and key recent topics are mentioned like pancreatic cancer screening, arteficial intelligence, resection of low-risk neoplastic lesions, enteroscopy techniques, cholangio- and pancreatiscopy and extraluminal expansion of endoscopy techniques by means of endoscopic submucosal and transmural dissection, endoscopic myotomy and lumen apposing stents.

Endoscopic full-thickness resection versus endoscopic submucosal dissection in the treatment of colonic neoplastic lesions ≤ 30 mm-a single-center experience.

Endoscopic full-thickness resection (FTR) is a novel technique of endoscopic treatment of colorectal neoplastic lesions not suitable for endoscopic polypectomy or mucosal resection. FTR appears to be a reasonable alternative to technically demanding endoscopic submucosal dissection (ESD) for lesions ≤ 30 mm. However, comparison between FTR and ESD has not been published yet and their mutual positioning in the treatment algorithm is still unclear. The purpose of the analysis was to evaluate efficacy and safety of FTR in the treatment of colorectal lesions ≤ 30 mm by comparing prospectively followed FTR cohort to retrospective ESD cohort in the setting of single tertiary endoscopy center. Primary outcomes were technical success rate, R0 resection and curative resection rate, and complication rate. A total of 52 patients in FTR and 50 patients in ESD group were treated between 2015 and 2018. Technical success rate was significantly higher in FTR group (92 vs. 74%, P = 0.01) as well as R0 resection rate (85 vs. 62%, P = 0.01) and curative resection rate (75 vs. 56%, P = 0.01). Complications occurred more frequently in ESD group (40 vs. 13%, P = 0.002), mainly due to high incidence of electrocoagulation syndrome (24 vs. 0%). Total procedure time was substantially shorter in FTR group (26.4 ± 11.0 min vs. estimated 90-240 min). Local residual neoplastic lesions were detected numerically more often in FTR group (12 vs. 5%, P = 0.12). No patient died during follow-up. Compared to ESD, FTR proved significantly higher technical success rate, higher R0 and curative resection rate, and shorter procedure time. In the FTR group, there were significantly less complications but higher incidence of local residual neoplasia. Further research including randomized trials is needed to compare both resection techniques.

Endoscopic treatment of early colorectal cancer.

Early colorectal neoplasia is a localized precancerous lesion of the large intestine associated with negligible risk of lymphatic or systemic dissemination. Early neoplasia consists of adenoma with low- and high-grade dysplasia, intramucosal carcinoma and superficially invasive cancer without other high-risk features. In the majority of cases, early neoplastic lesions are detected by colonoscopy and treated by means of endoscopy resection replacing surgical treatment. Risk of invasive cancer should be stratified during diagnostic colonoscopy using morphological classifications and then, appropriate resection technique (endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or full-thickness resection) is used. Success of endoscopic resection is assessed by histological examination of the resected specimen and in some cases, additional surgical resection with lymphadenectomy should be performed. Colonoscopic surveillance is needed due to the risk of local recurrence and metachronous lesions.

A cirrhotic patient in an internal medicine ward.

Liver cirrhosis represents a common condition with substantial mortality. Manifestation and progression of ascites, hepatic encephalopathy or gastrointestinal bleeding are among main reasons for hospital admission. Infections represent another specific area in cirrhotic patients. Timely and correct diagnosis and therapy of these conditions are the mainstay of optimal outcome. Manifestation of complications of liver cirrhosis significantly deteriorates prognosis of the patient. Ascites in portal hypertension develops as a result of sodium and consequently water retention. Therapy comprises of restriction of sodium intake, diuretic therapy with combination of spironolactone and furosemide, alternatively large-volume paracentesis. Hepatic encephalopathy comprises a spectrum of neuropsychiatric abnormalities from subtle changes to overt desorientation and asterixis to hepatic coma. Treatment includes correcting of predisposing conditions, administering of non-absorbable disaccharides or rifaximin. The most common cause of bleeding in a cirrhotic patient is oesophageal bleeding. Therapy is complex including hemodynamic stabilisation, antibiotic prophylaxis, vasoactive and endoscopic treatment. Infections are common causes of decompensation and occurrence of complications of advanced chronic liver disease. Their unfavourable outcome is a result of a complex immune disorder in cirrhotic patients. Specific type of infection in cirrhosis is spontaneous bacterial peritonitis, which has to be always excluded with diagnostic paracentesis. The mainstay of successful therapy of infections is timely and vigorous broad spectrum antibiotic therapy which can significantly improve otherwise unfavourable outcome of these patients.

Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations.

BACKGROUND AND AIMS: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. METHODS: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. RESULTS: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). CONCLUSIONS: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.

Extraintestinal complications of inflammatory bowel diseases.

Inflammatory bowel disease (IBD) includes Crohns disease (CD) and ulcerative colitis (UC). Those are chronic gastrointestinal disorders of inflammatory nature and not fully known etiology. As a result of their immune-mediated mechanism and complex impact on the whole organism other organs than gastrointestinal system may be affected in many ways. These extraintestinal manifestations (EIM) and complications may severely deteriorate prognosis of the patient, cause his morbidity and worsen the quality of life. While classical extraintestinal manifestations, such as enteropathic arthropathy, skin or eye involvement or primary sclerosing cholangitis, share common immunopathological mechanism with IBD, whole range of other disorders may result from various anatomical or metabolic abnormalities caused by IBD or its treatment. This review focus on the most common extraintestinal complications, such as anaemia, metabolic bone disease, biliary and urolithiasis, which we meet in our daily clinical practice.

Water Exchange (WE) and Quality Improvement-Enhanced Advanced Adenoma Detection: A Pooled Data Analysis of 6 Randomized Controlled Trials.

INTRODUCTION: Advanced adenomas (≥10 mm in diameter, >25% villous, or high-grade dysplasia), a marker of colorectal cancer risk, are used to stratify patients for closer surveillance. Modern accessories, endoscopes, and age-adjusted evaluation have variable impacts on the advanced adenoma detection rate (AADR). In 1 randomized controlled trial (RCT) comparing air insufflation (AI) with water exchange (WE), the right colon AADR was significantly increased by WE. Four network meta-analyses reported that WE significantly increased overall adenoma detection rate (ADR), but the impact on AADR was not addressed. AIM: The aim of this study was to test the hypothesis that WE significantly increased AADR compared with AI. METHOD: Six Clinicaltrial.gov-registered RCTs were reported by a group of WE investigators. Data including AADR (primary outcome) and overall ADR (secondary outcome) were pooled. RESULTS: A total of 5407 patients were randomized to AI (2699) and WE (2708). Compared with AI, WE significantly increased AADR (5.7% vs. 8.3%, P=0.001) and overall ADR (20.9% vs. 27.4%, P=0.001). CONCLUSIONS: In contrast to published reports, which showed variable impacts on AADR, WE was consistent in increasing AADR in 6 reported RCTs. The pooled data confirm that the impact of WE in increasing AADR was significant. The significantly enhanced overall ADR indicated that WE provided a higher quality outcome than AI. The significant improvement in AADR confirmed WE to be clinically relevant and has finally arrived as a timely addition to colorectal cancer prevention programs.

Water Exchange Produces Significantly Higher Adenoma Detection Rate Than Water Immersion: Pooled Data From 2 Multisite Randomized Controlled Trials.

GOALS: To test the hypothesis that water exchange (WE) significantly increases adenoma detection rates (ADR) compared with water immersion (WI). BACKGROUND: Low ADR was linked to increased risk for interval colorectal cancers and related deaths. Two recent randomized controlled trials of head-to-head comparison of WE, WI, and traditional air insufflation (AI) each showed that WE achieved significantly higher ADR than AI, but not WI. The data were pooled from these 2 studies to test the above hypothesis. STUDY: Two trials (5 sites, 14 colonoscopists) that randomized 1875 patients 1:1:1 to AI, WI, or WE were pooled and analyzed with ADR as the primary outcome. RESULTS: The ADR of AI (39.5%) and WI (42.4%) were comparable, significantly lower than that of WE (49.6%) (vs. AI P=0.001; vs. WI P=0.033). WE insertion time was 3 minutes longer than that of AI (P<0.001). WE showed significantly higher detection rate (vs. AI) of the >10 mm advanced adenomas. Right colon combined advanced and sessile serrated ADR of AI (3.4%) and WI (5%) were comparable and were significantly lower than that of WE (8.5%) (vs. AI P<0.001; vs. WI P=0.039). CONCLUSIONS: Compared with AI and WI, the superior ADR of WE offsets the drawback of a significantly longer insertion time. For quality improvement focused on increasing adenoma detection, WE is preferred over WI. The hypothesis that WE could lower the risk of interval colorectal cancers and related deaths should be tested.

Performance measures for endoscopy services: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

The European Society of Gastrointestinal Endoscopy (ESGE) and United European Gastroenterology present a list of key performance measures for endoscopy services. We recommend that these performance measures be adopted by all endoscopy services across Europe. The measures include those related to the leadership, organization, and delivery of the service, as well as those associated with the patient journey. Each measure includes a recommendation for a minimum and target standard for endoscopy services to achieve. We recommend that all stakeholders in endoscopy take note of these ESGE endoscopy services performance measures to accelerate their adoption and implementation. Stakeholders include patients and their advocacy groups; service leaders; staff, including endoscopists; professional societies; payers; and regulators.

Digital cholangioscopy: the diagnostic yield and impact on management of patients with biliary stricture.

OBJECTIVES: Biliary strictures frequently present a diagnostic challenge. The aim of this study was to evaluate the impact of digital single-operator cholangioscopy (DSOC) on subsequent treatment of patients with biliary stricture. METHODS: Consecutive patients undergoing DSOC for biliary stricture were enrolled. Gold standard for final diagnosis included histology from surgical resection. In patients without surgery, clinical evaluation methods and repeated imaging studies were used for comparison of DSOC findings and final diagnosis. Patients were followed-up prospectively focusing on subsequent treatment. RESULTS: Among 30 enrolled patients, final diagnosis was malignant in 13 (43%) and benign in 17 (57%). The sensitivity and specificity of visual impression in diagnosing malignant stricture were 100% (95% CI: 75 - 100) and 76% (95% CI: 50 - 93), respectively. The sensitivity and specificity for biopsy were 92% (95% CI: 62 - 100) and 100% (95% CI: 78 - 100), respectively. One (3%) case of complicating cholangitis with fatal outcome occurred. Final treatment included surgery in 7 (23%), endoscopy in 18 (60%) and chemotherapy in 3 (10%) of patients. CONCLUSIONS: In this study, favorable operating characteristics of DSOC were confirmed. Absolute negative predictive value of visual impression provided reassurance to patients with benign strictures who avoided unnecessary surgery in 53%. One (3%) case of cholangitis with fatal outcome occurred.

Therapeutic digestive endoscopy I.

Digestive endoscopy today is able to examine the whole gastrointestinal tract. On the basis of the originally purely diagnostic procedures a range of therapeutic modalities has been developed over years, which in some indications have taken the place of surgical procedures and methods of invasive radiology. Of greatest importance are the methods of endoscopic resection and ablation designed for the treatment of early neoplasms of the digestive tract not accompanied by a significant risk of lymphatic and systemic dissemination. Resection methods include endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection and endoscopic transmural resection. Regarding ablation methods, commonly used in clinical practice are radiofrequency ablations in the treatment of dysplasia in Barrett's esophagus and argon plasma coagulation used in the treatment of symptomatic vascular malformations and small local residual neoplasms. Key words: digestive endoscopy - endoscopic ablation - endoscopic mucosal resection - endoscopic polyp-ectomy - endoscopic resection - endoscopic submucosal dissection - endoscopic transmural resection.

Therapeutic digestive endoscopy II.

Digestive endoscopy today is able to examine the whole gastrointestinal tract. On the basis of the originally purely diagnostic procedures a range of therapeutic modalities was developed over years, which in some indications have taken the place of surgical procedures and methods of invasive radiology. Apart from the methods of endoscopic resection of early neoplasms of the digestive tract, digestive endoscopy plays an important role in diagnosing and treatment of bleeding and stenoses of the gastrointestinal tract. Plastic or self-expansible metal stents are introduced in the treatment of stenoses. Endoscopic retrograde cholangiopancreatography is a combined procedure capable of probing and intervening in the bile ducts and pancreatic duct under skiascopic control. Their direct visualization is possible with the method of oral cholangiopancreatoscopy. Endosonography-guided drainage and subsequent endoscopic necrectomy have become mini-invasive alternatives in the treatment of peripancreatic fluid collections. Key words: digestive endoscopy - endoscopic dilatation - endoscopic hemostasis - endoscopic retrograde chol-angiopancreatography - endosonography - cholangiopancreatography - stents.

Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial.

BACKGROUND AND AIMS: Water exchange (WE) is the least painful insertion method during colonoscopy. Its impact on postcolonoscopy discomfort has not been well-described. Carbon dioxide (CO2) insufflation consistently reduced postcolonoscopy discomfort. We compared postcolonoscopy outcomes of various combinations of insertion and withdrawal techniques (insertion-withdrawal modality): WE-CO2, WE-air insufflation (WE-AI), and CO2-CO2. METHODS: A total of 240 patients undergoing on-demand sedation diagnostic colonoscopy were randomized to WE-CO2 (n = 79), WE-AI (n = 80), CO2-CO2 (n = 81), with postprocedural data collected up to 24 hours. The primary outcome was postcolonoscopy bloating. Other postcolonoscopy outcomes included pain scores, flatus and incontinence episodes, toilet use, interference with normal activities, patient satisfaction, and patient willingness to repeat the procedure. RESULTS: Demographic and procedural data were comparable. Compared with WE-AI, WE-CO2 and CO2-CO2 resulted in significantly less bloating (all P < .0005) and lower pain scores (P values ranged from .008 to < .0005) up to 3 hours and fewer flatus episodes up to 6 hours (P values ranged from .003 to < .0005). WE-CO2 resulted in less interference with same-day activities compared with WE-AI (P = .043). The differences in postprocedural outcomes were significant, but the magnitude was small. Patient satisfaction and willingness to repeat the procedure were high and comparable among groups. WE was the least painful insertion technique (P < .0005). CONCLUSIONS: The combination WE-CO2 appears to be the optimal choice to decrease pain during the examination and to reduce bloating and other undesired procedural outcomes afterward. If a CO2 insufflator is already available, it seems advisable to adopt the combination WE-CO2. In the absence of a CO2 insufflator, the cost effectiveness of the addition of withdrawal CO2 to WE in diagnostic and nondiagnostic settings needs to be critically assessed. (Clinical trial registration number: NCT02409979.).

Water exchange for screening colonoscopy increases adenoma detection rate: a multicenter, double-blinded, randomized controlled trial.

Background and study aims Single-center studies, which were retrospective and/or involved unblinded colonoscopists, have suggested that water exchange, but not water immersion, compared with air insufflation significantly increases the adenoma detection rate (ADR), particularly in the proximal and right colon. Head-to-head comparison of the three techniques with ADR as primary outcome and blinded colonoscopists has not been reported to date. In a randomized controlled trial with blinded colonoscopists, we aimed to evaluate the impact of the three insertion techniques on ADR. Patients and methods A total of 1224 patients aged 50 - 70 years (672 males) and undergoing screening colonoscopy were randomized 1:1:1 to water exchange, water immersion, or air insufflation. Split-dose bowel preparation was adopted to optimize colon cleansing. After the cecum had been reached, a second colonoscopist who was blinded to the insertion technique performed the withdrawal. The primary outcome was overall ADR according to the three insertion techniques (water exchange, water immersion, and air insufflation). Secondary outcomes were other pertinent overall and right colon procedure-related measures. Results Baseline characteristics of the three groups were comparable. Compared with air insufflation, water exchange achieved a significantly higher overall ADR (49.3 %, 95 % confidence interval [CI] 44.3 % - 54.2 % vs. 40.4 % 95 %CI 35.6 % - 45.3 %; P  = 0.03); water exchange showed comparable overall ADR vs. water immersion (43.4 %, 95 %CI 38.5 % - 48.3 %; P  = 0.28). In the right colon, water exchange achieved a higher ADR than air insufflation (24.0 %, 95 %CI 20.0 % - 28.5 % vs. 16.9 %, 95 %CI 13.4 % - 20.9 %; P  = 0.04) and a higher advanced ADR (6.1 %, 95 %CI 4.0 % - 9.0 % vs. 2.5 %, 95 %CI 1.2 % - 4.6 %; P = 0.03). Compared with air insufflation, the mean number of adenomas per procedure was significantly higher with water exchange (P = 0.04). Water exchange achieved the highest cleanliness scores (overall and in the right colon). These variables were comparable between water immersion and air insufflation. Conclusions The design with blinded observers strengthens the validity of the observation that water exchange, but not water immersion, can achieve significantly higher adenoma detection than air insufflation. Based on this evidence, the use of water exchange should be encouraged.Trial registered at ClinicalTrials.gov (NCT02041507).

Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn's disease and ulcerative colitis.

OBJECTIVE: The infliximab biosimilar CT-P13 (Remsima(®), Inflectra(®)) was approved in Europe for the treatment of inflammatory bowel disease (IBD) based on extrapolation of data from patients with rheumatic disease. Because there are limited published reports on clinical outcomes for IBD patients treated with CT-P13, we monitored responses to induction treatment with this biosimilar in patients with Crohn's disease (CD) or ulcerative colitis (UC) in centres across the Czech Republic. MATERIAL AND METHODS: Fifty-two patients with CD (n = 30) or UC (n = 22) were treated with 5 mg/kg CT-P13 for up to 14 weeks. Effectiveness of therapy was evaluated with the Crohn's Disease Activity Index (CDAI) or the Mayo Scoring System (MSS) in patients with CD or UC, respectively, before and after 14 weeks. Additional goals were to evaluate weight changes, serum C-reactive protein (CRP) levels, and complications/adverse events. RESULTS: In patients with CD, remission (CDAI <150) was achieved in 50.0% of cases, and partial response (≥70-point decrease in CDAI score from baseline) in the remaining 50.0%. In patients with UC, remission (total score on partial Mayo index ≤2 points) was achieved in 40.9% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 54.5%, and no response in 4.5%. There were statistically significant improvements in CDAI, MSS and CRP serum levels after 14 weeks of therapy, and body weight increased. Four adverse events were identified (n = 1 each): lower-extremity phlebothrombosis, herpes labialis, pneumonia and allergic reaction. CONCLUSIONS: This prospective observational study provides evidence of the effectiveness of CT-P13 in IBD.

Impact of Colonoscopy Insertion Techniques on Adenoma Detection.

BACKGROUND: Low adenoma detection rate (ADR) predicts development of interval cancers, found mainly in the right (cecum-ascending) colon, where poor bowel preparation is an associated factor. Single-site studies reported increased detection of adenomas in the proximal colon segments by water exchange (WE). Data about colon cleansing revealed that WE had the greatest impact in the right colon. AIMS: To test the hypothesis that WE had the greatest impact on ADR in colon segments with the most favorable bowel cleanliness scores, namely the right colon. METHODS: We pooled right colon and overall ADR data of three similarly designed colonoscopy trials that compared WE, water immersion (WI) and insufflation of air or carbon dioxide (AICD) in a mixed gender European population. RESULTS: In this study, 1200 (704 males) subjects and were included. 288 were screening cases. Demographic and procedural data were comparable. Water exchange achieved significantly higher right colon <10 mm ADR (11.9 %, vs WI 6.9 %, p = 0.016; vs AICD 7.2 %, p = 0.025). Water exchange achieved the lowest proportions of poor bowel preparation and the highest right colon and overall Boston bowel preparation scale scores (p range 0.003, <0.0005). In patients with right colon excellent bowel cleanliness, water exchange was the only method significantly associated with right colon adenoma detection. One of the limitations is unblinded colonoscopists. CONCLUSIONS: In a mixed gender European population, water exchange is confirmed to be a superior insertion technique showing a significant increase in <10 mm right colon adenoma detection, achieving the cleanest colon and lowest proportions of poor bowel preparation requiring repeat procedures. CLINICALTRIALS. GOV NO: NCT01781650, 01954862, 01780818.