Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial.

BACKGROUND & AIMS: Gastrointestinal angiodysplasias are vascular anomalies that may result in transfusion-dependent anemia despite endoscopic therapy. An individual patient data meta-analysis of cohort studies suggests that octreotide decreases rebleeding rates, but component studies possessed a high risk of bias. We investigated the efficacy of octreotide in reducing the transfusion requirements of patients with angiodysplasia-related anemia in a clinical trial setting. METHODS: The study was designed as a multicenter, open-label, randomized controlled trial. Patients with angiodysplasia bleeding were required to have had at least 4 red blood cell (RBC) units or parental iron infusions, or both, in the year preceding randomization. Patients were allocated (1:1) to 40-mg octreotide long-acting release intramuscular every 28 days or standard of care, including endoscopic therapy. The treatment duration was 1 year. The primary outcome was the mean difference in the number of transfusion units (RBC + parental iron) between the octreotide and standard of care groups. Patients who received at least 1 octreotide injection or followed standard of care for at least 1 month were included in the intention-to-treat analyses. Analyses of covariance were used to adjust for baseline transfusion requirements and incomplete follow-up. RESULTS: We enrolled 62 patients (mean age, 72 years; 32 men) from 17 Dutch hospitals in the octreotide (n = 31) and standard of care (n = 31) groups. Patients required a mean number of 20.3 (standard deviation, 15.6) transfusion units and 2.4 (standard deviation, 2.0) endoscopic procedures in the year before enrollment. The total number of transfusions was lower with octreotide (11.0; 95% confidence interval [CI], 5.5-16.5) compared with standard of care (21.2; 95% CI, 15.7-26.7). Octreotide reduced the mean number of transfusion units by 10.2 (95% CI, 2.4-18.1; P = .012). Octreotide reduced the annual volume of endoscopic procedures by 0.9 (95% CI, 0.3-1.5). CONCLUSIONS: Octreotide effectively reduces transfusion requirements and the need for endoscopic therapy in patients with angiodysplasia-related anemia. CLINICALTRIALS: gov, NCT02384122.

Translation, validation and psychometric properties of the Dutch version of the Inflammatory Bowel Disease-Fatigue (IBD-F) self-assessment scale.

BACKGROUND: In patients with inflammatory bowel disease (IBD), a symptom with major impact on health-related quality of life is fatigue. To assess fatigue and conduct research regarding fatigue in IBD patients, a validated disease specific assessment tool is required. The aim of this study was to translate the Inflammatory Bowel Disease Fatigue patient self-assessment scale (IBD-F) into Dutch and to validate this translated scale in a Dutch IBD population. METHODS: The study comprised three phases. In phase 1, the original IBD-F was translated into Dutch. Phase 2 comprised a pilot-test of the pre-final Dutch IBD-F to assess content validity by applying a semi-structured interview design. In phase 3, construct validity, internal consistency and test-retest reliability were assessed using a cross-sectional design. RESULTS: Phase 1 resulted in the pre-final version of the Dutch IBD-F. After five semi-structured interviews with IBD patients in phase 2, minor adjustments were made which resulted in the final version of the Dutch IBD-F. Evaluation of this final version in 133 IBD patients showed adequate psychometric properties: good convergent validity with the Multidimensional Fatigue Inventory subscales (Spearman's r 0.57-0.86) and excellent internal consistency (Cronbach's alpha 0.94 for Section I and 0.97 for Section II). Test-retest reliability in 102 patients was shown to be good (Section I ICC 0.85 (95% CI 0.79-0.90) and Section II ICC 0.88 (95% CI 0.83-0.92)). CONCLUSIONS: The thorough translation process resulted in a comprehensible, valid and reliable version of the Dutch IBD-F. Convergent validity with the MFI-20 appeared to be good. This study found excellent internal consistency and good test-retest reliability.

Therapeutic Drug Monitoring of Vedolizumab in Inflammatory Bowel Disease Patients during Maintenance Treatment-TUMMY Study.

There are limited data on therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) patients treated with vedolizumab (VDZ). Although an exposure-response relation has been demonstrated in the post-induction phase, this relationship is more uncertain in the maintenance phase of treatment. The aim of our study was to determine whether there is an association between VDZ trough concentration and clinical and biochemical remission in the maintenance phase. A prospective, observational multicenter study has been performed on patients with IBD on VDZ in the maintenance treatment (≥14 weeks). Patient demographics, biomarkers, and VDZ serum trough concentrations were collected. Clinical disease activity was scored by the Harvey Bradshaw Index (HBI) for Crohn's disease (CD) and the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Clinical remission was determined as HBI < 5 and SCCAI < 3. Biochemical remission was defined as fecal calprotectin <250 mg/kg and serum CRP <5 mg/L. A total of 159 patients (59 CD, 100 UC) were included. In none of the patient groups, a statistically significant correlation between trough VDZ concentration and clinical remission was observed. Patients in biochemical remission had higher VDZ trough concentrations (p = 0.019). In this population, higher trough VDZ concentrations were associated with biochemical remission but not with clinical remission.

Relapse rates after withdrawal versus maintaining biologic therapy in IBD patients with prolonged remission.

Biologic treatment withdrawal in inflammatory bowel disease patients with prolonged remission may lead to benefits but also increases the risk of getting a relapse. The risk of relapse after biologic withdrawal according to the Dutch STOP-criteria is still unknown. The aim of this study was to compare the cumulative incidence of relapse in inflammatory bowel disease patients that discontinued biologic therapy after applying the STOP-criteria with patients who maintained biologic therapy. We performed a mono-centre, observational, retrospective study by evaluating relapse risk of patients treated with biologic agents who discontinued this treatment according to the STOP-criteria (STOP-group) compared to patients who were in remission for more than 3 years before withdrawal (LATERSTOP-group) and patients who continued their biologic (MAINTAIN-group). The cumulative risk was calculated at 12 and 36 months using the log-rank test to compare Kaplan-Meier curves. Eighty-three of 398 patients that used biologics between 1 January 2010 and 1 January 2020 were included. The cumulative relapse incidences in the STOP-group and the LATERSTOP-group were, respectively, 29% and 42% at 12 months and 47% versus 58% at 36 months. Patients in the MAINTAIN-group showed a lower (p = 0.03) cumulative relapse incidence of 10% at 12 months and 18% at 36 months. Patients who discontinued their biologic therapy according to the STOP-criteria had significantly more relapses at 12 and 36 months than patients who maintained biologic treatment.

Exposure to Thioguanine During 117 Pregnancies in Women With Inflammatory Bowel Disease.

BACKGROUND: Safety of thioguanine in pregnant patients with inflammatory bowel disease [IBD] is sparsely recorded. This study was aimed to document the safety of thioguanine during pregnancy and birth. METHODS: In this multicentre case series, IBD patients treated with thioguanine during pregnancy were included. Data regarding disease and medication history, pregnancy course, obstetric complications, and neonatal outcomes were collected. RESULTS: Data on 117 thioguanine-exposed pregnancies in 99 women were collected. Most [78%] had Crohn's disease and the mean age at delivery was 31 years. In 18 pregnancies [15%], IBD flared. Obstetric and infectious complications were seen in 15% [n = 17] and 7% [n = 8] of pregnancies, respectively. Ten pregnancies [8.5%] resulted in a first trimester miscarriage, one in a stillbirth at 22 weeks of gestational age and one in an induced abortion due to trisomy 21. In total, 109 neonates were born from 101 singleton pregnancies and four twin pregnancies. One child was born with a congenital abnormality [cleft palate]. In the singleton pregnancies, 10 children were born prematurely and 10 were born small for gestational age. Screening for myelosuppresion was performed in 16 neonates [14.7%]; two had anaemia in umbilical cord blood. All outcomes were comparable to either the general Dutch population or to data from three Dutch cohort studies on the use of conventional thiopurines in pregnant IBD patients. CONCLUSION: In this large case series, the use of thioguanine during pregnancy is not associated in excess with adverse maternal or neonatal outcomes.

Neither inflammatory bowel disease nor immunosuppressants are associated with an increased risk of severe COVID-19: an observational Dutch cohort study.

Conflicting data about inflammatory bowel disease [IBD] and immunosuppressants are risk factors for severe COVID-19 confuse patients and healthcare providers. Clinical reports with longer follow-up are lacking. A retrospective search was performed for severe COVID-19 (hospital admission and/or mortality) one year after the SARS-CoV-2 outbreak in an IBD cohort from one of the most affected Dutch regions. Cohort characteristics were explored by value-based healthcare data, including immunotherapy. COVID-19 cases were detected by ICD-10 codes and further examined for IBD determinants (including medication) and COVID-19 characteristics (intensive care admission, respiratory support, treatment, mortality). The national mortality register was consulted, ensuring detection of patients that died without admission. Results were compared with regional and national general population registries. The IBD cohort consisted of 1453 patients (51% Crohn's disease, 54% women, 39.9% using immunotherapy), including children. Biologics use increased during the study. Eight cases (0.55%) had severe COVID-19: seven were hospitalized (0.48%, 95% confidence interval [CI] 0.21-1.04), and two died (0.14%, CI 0.002-0.55). Six patients had comorbidity, one used immunotherapy, and four had no medication. Both deceased patients were older than 80 years, had severe comorbidity, but used no immunotherapy. Hospitalization occurred significantly more in the IBD cohort than regionally (0.18%, CI 0.17-0.19, p = 0.015), but not significantly more than nationally (0.28%, CI 0.279-0.284). Mortality was equal in IBD patients, regionally (0.11%, CI 0.10-0.12) and nationally (0.13%, CI 0.125-0.128). Neither IBD nor immunosuppressants are associated with increased risks of severe COVID-19 in an observational study with one-year follow-up.

Algorithm combining virtual chromoendoscopy features for colorectal polyp classification.

Background and study aims Colonoscopy is considered the gold standard for decreasing colorectal cancer incidence and mortality. Optical diagnosis of colorectal polyps (CRPs) is an ongoing challenge in clinical colonoscopy and its accuracy among endoscopists varies widely. Computer-aided diagnosis (CAD) for CRP characterization may help to improve this accuracy. In this study, we investigated the diagnostic accuracy of a novel algorithm for polyp malignancy classification by exploiting the complementary information revealed by three specific modalities. Methods We developed a CAD algorithm for CRP characterization based on high-definition, non-magnified white light (HDWL), Blue light imaging (BLI) and linked color imaging (LCI) still images from routine exams. All CRPs were collected prospectively and classified into benign or premalignant using histopathology as gold standard. Images and data were used to train the CAD algorithm using triplet network architecture. Our training dataset was validated using a threefold cross validation. Results In total 609 colonoscopy images of 203 CRPs of 154 consecutive patients were collected. A total of 174 CRPs were found to be premalignant and 29 were benign. Combining the triplet network features with all three image enhancement modalities resulted in an accuracy of 90.6 %, 89.7 % sensitivity, 96.6 % specificity, a positive predictive value of 99.4 %, and a negative predictive value of 60.9 % for CRP malignancy classification. The classification time for our CAD algorithm was approximately 90 ms per image. Conclusions Our novel approach and algorithm for CRP classification differentiates accurately between benign and premalignant polyps in non-magnified endoscopic images. This is the first algorithm combining three optical modalities (HDWL/BLI/LCI) exploiting the triplet network approach.

Outcome of Reverse Switching From CT-P13 to Originator Infliximab in Patients With Inflammatory Bowel Disease.

BACKGROUND: Patients suffering from inflammatory bowel diseases (IBD) and treated with originator infliximab are increasingly being switched to biosimilars. Some patients, however, are "reverse switched" to treatment with the originator. Here we assess the prevalence of reverse switching, including its indication and outcomes. METHODS: In this retrospective multicenter cohort study, data on patients with IBD from 9 hospitals in the Netherlands were collected. All adult patients with IBD were included if they previously had been switched from originator infliximab to the biosimilar CT-P13 and had a follow-up time of at least 52 weeks after the initial switch. The reasons for reverse switching were categorized into worsening gastrointestinal symptoms, adverse effects, or loss of response to CT-P13. Drug persistence was analyzed through survival analyses. RESULTS: A total of 758 patients with IBD were identified. Reverse switching was observed in 75 patients (9.9%). Patients with reverse switching were predominantly female (70.7%). Gastrointestinal symptoms (25.5%) and dermatological symptoms (21.8%) were the most commonly reported reasons for reverse switching. In 9 patients (12.0%), loss of response to CT-P13 was the reason for reverse switching. Improvement of reported symptoms was seen in 73.3% of patients after reverse switching and 7 out of 9 patients (77.8%) with loss of response regained response. Infliximab persistence was equal between patients who were reverse-switched and those who were maintained on CT-P13. CONCLUSIONS: Reverse switching occurred in 9.9% of patients, predominantly for biosimilar-attributed adverse effects. Switching back to originator infliximab seems effective in patients who experience adverse effects, worsening gastrointestinal symptoms, or loss of response after switching from originator infliximab to CT-P13.

Clinical Outcomes of Covid-19 in Patients With Inflammatory Bowel Disease: A Nationwide Cohort Study.

BACKGROUND AND AIMS: The COVID-19 risk and disease course in inflammatory bowel disease [IBD] patients remains uncertain. Therefore, we aimed to assess the clinical presentation, disease course, and outcomes of COVID-19 in IBD patients. Second, we determined COVID-19 incidences in IBD patients and compared this with the general population. METHODS: We conducted a multicentre, nationwide IBD cohort study in The Netherlands and identified patients with COVID-19. First, we assessed the COVID-19 disease course and outcomes. Second, we compared COVID-19 incidences between our IBD study cohort and the general Dutch population. RESULTS: We established an IBD cohort of 34 763 patients. COVID-19 was diagnosed in 100/34 763 patients [0.29%]; 20/100 of these patients [20%] had severe COVID-19 defined as admission to the intensive care unit, mechanical ventilation, and/or death. Hospitalisation occurred in 59/100 [59.0%] patients and 13/100 [13.0%] died. All patients who died had comorbidities and all but one were ≥65 years old. In line, we identified ≥1 comorbidity as an independent risk factor for hospitalisation (odds ratio [OR] 4.20, 95% confidence interval [CI] 1.58-11.17,; p = 0.004). Incidences of COVID-19 between the IBD study cohort and the general population were comparable (287.6 [95% CI 236.6-349.7] versus 333.0 [95% CI 329.3-336.7] per 100000 patients, respectively; p = 0.15). CONCLUSIONS: Of 100 cases with IBD and COVID-19, 20% developed severe COVID-19, 59% were hospitalised and 13% died. A comparable COVID-19 risk was found between the IBD cohort [100/34 763 = 0.29%] and the general Dutch population. The presence of ≥1 comorbidities was an independent risk factor for hospitalisation due to COVID-19.

The prevalence of nodular regenerative hyperplasia of the liver in long-term thiopurine-treated inflammatory bowel disease patients.

INTRODUCTION: Nodular regenerative hyperplasia (NRH) has been associated with thiopurine therapy in patients with inflammatory bowel disease (IBD), but prevalence and prognosis of NRH remain unclear. This study is a cross-sectional search for NRH in IBD patients with long-term azathioprine or 6-mercaptopurine treatment. MATERIAL AND METHODS: Thirty-three IBD patients with continuous azathioprine/6-mercaptopurine treatment for at least 5 years were included. Laboratory tests, thiopurine metabolite levels, liver histology, MRI were examined for NRH and signs of portal hypertension. RESULTS: NRH was not observed in this cohort of 33 patients. Nevertheless, some possibly related signs of vascular changes were found by MRI in three patients. Also, splenomegaly, which may be associated with portal hypertension, was found in one patient. No high thiopurine dose neither high metabolite levels were found in these patients. CONCLUSION: No NRH was found in this group of IBD patients with long-term azathioprine/6-mercaptopurine treatment. Larger multicenter studies are needed to determine the prevalence of NRH in thiopurine-treated IBD patients.

Customized bariatric stents for sleeve gastrectomy leak: are they superior to conventional esophageal stents? A systematic review and proportion meta-analysis.

OBJECTIVE: Recently, there has been a burgeoning interest in the utilization of customized bariatric stents (CBS) for management of sleeve gastrectomy leak (SGL). We aimed to conduct a proportion meta-analysis to evaluate the cumulative efficacy and safety of these new stents and to compare them with the conventional esophageal stents (CES). METHODS: A systematic literature search of the PubMed, Cochrane Library, Scopus, Web of Science and Google Scholar databases was conducted through May 1, 2020. Primary outcomes were technical and clinical success and post-procedure adverse events of CBS and CES. Secondary outcomes were number of stents and endoscopic sessions per patient, and time to leak closure. A proportion meta-analysis was performed on outcomes using a random-effects model, and the weighted pooled rates (WPRs) or mean difference with 95% confidence interval (CI) were calculated. RESULTS: The WPR with 95% CI of technical success, clinical success, and stent migration for CBS were 99% (93-100%) I2 = 34%, 82% (69-93%) I2 = 58%, and 32% (17-49%), I2 = 69%, respectively. For CES, the WPR (95% CI) for technical success, clinical success, and stent migration were 100% (97-100%) I2 = 19%, 93% (85-98%) I2 = 30%, and 15% (7-25%), I2 = 41%, respectively. Adverse events other than migration were very low with both types of stents. On proportionate difference, CBS had lower clinical success (11%) and higher migration rate (17%) in comparison to CES. In successfully treated patients, CBS was associated with lower mean number of stents and endoscopic sessions, and shorter time to leak closure compared to CES. The overall quality of evidence was very low. CONCLUSIONS: In treatment of SGL, there is very low level evidence that CES are superior to CBS in terms of clinical success and migration rate, though may require more stent insertions and endoscopic procedures. The evidence however remains very uncertain. Perhaps relevant to some types of stents, CBS are promising; however design modification is strongly recommended to improve outcomes.

Endoscopic full-thickness resection (eFTR) of colorectal lesions: results from the Dutch colorectal eFTR registry.

BACKGROUND: Endoscopic full-thickness resection (eFTR) is a minimally invasive resection technique that allows definite diagnosis and treatment for complex colorectal lesions ≤ 30 mm unsuitable for conventional endoscopic resection. This study reports clinical outcomes from the Dutch colorectal eFTR registry. METHODS: Consecutive patients undergoing eFTR in 20 hospitals were prospectively included. The primary outcome was technical success, defined as macroscopic complete en bloc resection. Secondary outcomes were: clinical success, defined as tumor-free resection margins (R0 resection); full-thickness resection rate; and adverse events. RESULTS : Between July 2015 and October 2018, 367 procedures were included. Indications were difficult polyps (non-lifting sign and/or difficult location; n = 133), primary resection of suspected T1 colorectal cancer (CRC; n = 71), re-resection after incomplete resection of T1 CRC (n = 150), and subepithelial tumors (n = 13). Technical success was achieved in 308 procedures (83.9 %). In 21 procedures (5.7 %), eFTR was not performed because the lesion could not be reached or retracted into the cap. In the remaining 346 procedures, R0 resection was achieved in 285 (82.4 %) and full-thickness resection in 288 (83.2 %). The median diameter of resected specimens was 23 mm. Overall adverse event rate was 9.3 % (n = 34/367): 10 patients (2.7 %) required emergency surgery for five delayed and two immediate perforations and three cases of appendicitis. CONCLUSION : eFTR is an effective and relatively safe en bloc resection technique for complex colorectal lesions with the potential to avoid surgery. Further studies assessing the role of eFTR in early CRC treatment with long-term outcomes are needed.

Percutaneous endoscopic versus radiologic gastrostomy for enteral feeding: a retrospective analysis on outcomes and complications.

Background and study aims Percutaneous endoscopic gastrostomy (PEG) and percutaneous radiologic gastrostomy (PRG) are techniques used for long-term enteral feeding. Our primary aim was to analyze procedure-related and 30-day mortality and complications between PEG and PRG in relation to indications. Patients and methods A single-center retrospective analysis was performed thath included all adult patients receiving initial PEG (January 2008 until April 2016) and PRG (January 2010 until April 2016). Outcomes were mortality (procedure-related, 30-day), complications (early (≤ 30 days) and late) and success rates. Results A total of 760 procedures (469 PRG and 291 PEG) were analyzed. Most common indications were head and neck cancer (HNC), cerebrovascular accident (CVA) and amyotrophic lateral sclerosis (ALS). Success rates for placement were 91.2 % for PEG and 97.1 % for PRG ( P  = 0.001). Procedure-related mortality was 1.7 % in PEG and 0.4 % in PRG ( P  = 0.113). The 30-day mortality was 10.7 % in PEG and 5.1 % in PRG ( P  = 0.481 after multivariate logistic regression) CVA was associated with higher 30-day mortality, whereas ALS, higher body weight, and prophylactic placements in HNC were associated with lower rates. Tube-related complications were less frequent in PEG, both early (2.7 % vs. 26.4 %, P  ≤ 0.001) and late (8.6 % vs. 31.5 %, P  ≤ 0.001). The percentage of major complications and infections did not differ. Conclusions With respect to procedure-related and 30-day mortality, PEG and PRG compare equally. PRG had a higher procedural success rate. Tube-related complications and pain are less frequent after PEG compared to PRG. The choice for either PEG or PRG therefore should primarily be based on local facilities and expertise.

Therapeutic strategies in gastroparesis: Results of stepwise approach with diet and prokinetics, Gastric Rest, and PEG-J: A retrospective analysis.

BACKGROUND: Gastroparesis is characterized by abnormal gastric motor function with delayed gastric emptying in the absence of mechanical obstruction. In our tertiary referral center, patients are treated with a stepwise approach, starting with dietary advice and prokinetics, followed by three months of nasoduodenal tube feeding with "gastric rest." When not successful, a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) for long-term enteral feeding is placed. AIM: To evaluate the effect of this stepwise approach on weight and symptoms. METHODS: Analyses of data of all referred gastroparesis patients between 2008 and 2016. KEY RESULTS: A total of 86 patients (71% female, 20-87 years [mean 55.8 years]) were analyzed of whom 50 (58%) had adequate symptom responses to diet and prokinetics. The remaining 36 (decompensated gastroparesis) were treated with three months gastric rest. Symptom response rate was 47% (17/36). Significant weight gain was seen in all patients, independent of symptom response. In the remaining 19 symptom non-responders, the enteral feeding was continued through PEG-J. Treatment was effective (symptoms) in 37%, with significant weight gain in all. In 84% of patients, the PEG-J is still in use (mean duration 962 days). CONCLUSIONS AND INFERENCES: Following a stepwise treatment approach in gastroparesis, adequate symptom response was reached in 86% of all patients. Weight gain was achieved in all patients, independent of symptom response. Diet and prokinetics were effective with regard to symptoms in 58%, temporary gastric rest in 47%, and PEG-J as third step in 37% of patients.

Influence of Helicobacter pylori infection on gastrointestinal symptoms and complications in bariatric surgery patients: a review and meta-analysis.

BACKGROUND: Numerous papers have discussed the importance of preoperative detection and eradication of Helicobacter pylori (HP) in bariatric patients. OBJECTIVES: This systematic review specifically focuses on the influence of HP infection on clinical symptoms, complications, and abnormal endoscopic findings in postbariatric patients. METHODS: A systematic search on the influence of HP infection on postoperative complications in bariatric surgery was conducted. The methodologic quality of the included studies was rated using the Newcastle-Ottawa rating scale. The agreement between the reviewers was assessed with Cohen's kappa. The included studies were assessed into 2 groups, studies with and without eradication therapy preoperatively. RESULTS: A total of 21 studies were included with a methodologic quality ranging from poor to good. The agreement between the reviewers, assessed with the Cohen's kappa, was .70. Overall, tendency in the included studies was that HP infection was associated with an increased risk for developing marginal ulcers and postoperative complications. A meta-analysis on the incidence of marginal ulcers and overall postoperative complications was conducted and showed, respectively, an odds ratio of .508 (.031-8.346) and 2.863 (.262-31.268). CONCLUSIONS: HP is frequently found in patients before and after bariatric and metabolic surgery. We assessed whether, according to the current literature, HP increases the risk for developing postoperative complications after surgery. This meta-analysis shows that a methodologically good study should be performed to clarify the role of HP in bariatric patients and the question of whether HP should be eradicated before surgery.

A Systematic Review and Meta-Analysis on Outcomes and Complications of Percutaneous Endoscopic Versus Radiologic Gastrostomy for Enteral Feeding.

BACKGROUND: The optimal technique for long-term enteral feeding has not yet been established. Both percutaneous endoscopic gastrostomy (PEG) and percutaneous radiologic gastrostomy (PRG) are widely used. Aim was to extensively review outcomes of PEG and PRG. MATERIALS AND METHODS: A systematic review using Medline, Embase, and Cochrane was performed, using standardized tools for assessing bias. Main outcomes were infectious and tube-related complications, procedure related and 30-day mortality. Pooled risk differences (RDs) with corresponding 95% confidence intervals (95% CIs) were calculated using random effects. Arcsine transformations were applied. RESULTS: In total, 344 studies were identified, of which 16 were included, reporting on 934 PEGs and 1093 PRGs. No differences were found for infectious complications [RD, 0.03 (-0.05 to 0.11)], procedure-related mortality [RD, 0.01 (-0.04 to 0.06)], or 30-day mortality [RD, 0.06 (-0.01 to 0.13)]. Tube-related complications were higher in PRG [RD, 0.16 (0.06-0.26)]. Subgroup analysis was performed for head and neck cancer (HNC) and motor neuron disease. In HNC, this revealed significantly lower tube-related complications and procedure-related mortality after PEG. In motor neuron disease, no differences were seen. The level of evidence appears sufficient considering the low degree of heterogeneity. CONCLUSIONS: No differences were found with regard to mortality or infectious complications. PEG showed lower risk of tube-related complications. Subgroup analysis revealed PEG to be favorable in HNC based on lower rates of procedure-related mortality and tube-related complications. Local experience and availability should be taken into account in the decision process.

Percutaneous endoscopic gastrostomy under conscious sedation in patients with amyotrophic lateral sclerosis is safe: an observational study.

OBJECTIVES: Amyotrophic lateral sclerosis (ALS) is a progressive neuromuscular disease that causes muscle weakness with respiratory and swallowing dysfunction, eventually leading to death. Permanent enteral feeding is indicated in almost all patients. A percutaneous endoscopic gastrostomy (PEG) tube is considered the first choice, usually performed under conscious sedation (intravenous midazolam). Guidelines are very cautious with respect to sedation in ALS because of the risk for respiratory complications. In our tertiary referral hospital, conscious sedation has been used for many years.Our aim was to review 30-day complications in PEG performed under conscious sedation in ALS patients (without noninvasive positive pressure ventilation during the procedure). PATIENTS AND METHODS: A retrospective review, including all ALS patients undergoing PEG under conscious sedation from October 2009 to April 2016, was performed. RESULTS: Analysis included 45 (44% men) patients receiving intravenous midazolam sedation (mean dose 5 mg) during PEG placement, age 36-91 years (mean: 68.7 years). Forced vital capacity (FVC) was 24-116% (mean 68%), of which mild to moderate dysfunction (FVC 50-69%) was present in 42.2% of patients and (very) severe dysfunction (FVC <50%) in 8.8%. No respiratory complications (e.g. aspiration pneumonia) were observed. Other complications, for example, infection, bleeding and peritonitis occurred in, respectively, 8.9, 2.2 and 0%. Mean survival after PEG placement was 13.4 months (range: 1-45 months). CONCLUSION: Conscious sedation during PEG insertion in ALS patients did not lead to respiratory complications or to an increase in other complications. Our data indicate that conscious sedation can be used safely in ALS patients with mild to moderate pulmonary dysfunction.

Short article: The effect of implementation of a treatment algorithm for infliximab on remission rates and drug costs in inflammatory bowel disease patients.

INTRODUCTION: The effective, but expensive, drug infliximab is used in patients with inflammatory bowel disease (IBD). Monitoring infliximab trough levels and anti-infliximab antibody (ATI) formation can lead to a more cost-effective use of infliximab therapy. The aim of our study was to investigate the effect of implementation of a treatment algorithm for infliximab in a single-centre IBD cohort, focussing on remission rates and drug costs. METHODS: IBD patients aged 18 years or older treated with infliximab were asked to participate in this study. Remission rates were assessed using faecal calprotectin levels and a validated questionnaire. Infliximab trough levels and ATIs were determined at baseline and at the third infliximab infusion. According to the advice given by the treatment algorithm, infliximab dosage adjustments were performed at the second infliximab infusion. RESULTS: Between January and December 2015 a total of 62 IBD patients in our centre were treated with infliximab, of whom 33 (53%) patients agreed to participate in this study. The number of patients in remission was 28 (85%) at baseline and there were 13 dose adaptations suggested by the treatment algorithm for the successive second infusion. Four patients possessed undetectable infliximab levels and positive ATI status at baseline. After the second infusion, there were 29 (88%) patients in remission at the third infusion. All of this resulted in an annual drug cost reduction of &OV0556;47 026 (7.4%). CONCLUSION: Our developed treatment algorithm of infliximab led to optimization of infliximab therapy in IBD patients by increasing remission rates and reducing drug costs.

Vedolizumab is an effective alternative in inflammatory bowel disease patients with anti-TNF-alpha therapy-induced dermatological side effects.

BACKGROUND: The treatment of patients with inflammatory bowel diseases has been revolutionized by the introduction of biological therapy with TNF-alpha blockers. However, TNF-alpha blockers are also associated with a wide variety of dermatological side effects, such as local skin infections, psoriasis and eczema. A new biological therapy, targeting the gut-specific adhesion molecule alpha4beta7 integrin, is the humanized monoclonal IgG1 antibody vedolizumab. Vedolizumab prevents leukocyte migration to the gastrointestinal tract, thereby reducing inflammation. This gut-specific therapy has the potential to reduce systemic side effects, including dermatological ones. METHODS: We describe 3 inflammatory bowel disease patients who experience anti-TNF-alpha therapy-induced dermatological side effects, consisting of hidradenitis suppurativa, a folliculitis, scalp psoriasis and a dissecting folliculitis. RESULTS: In all patients, anti-TNF-alpha therapy-induced dermatological side effects diminished after switching to vedolizumab. CONCLUSION: Vedolizumab may be a viable alternative biological therapy in inflammatory bowel disease patients who experience anti-TNF-alpha therapy-induced dermatological side effects.