Assessment of radiation doses received by patients during endoscopic retrograde cholangiopancreatography according to disease location.

OBJECTIVE: patients are exposed to ionizing radiation during endoscopic retrograde cholangiopancreatography (ERCP). Radiation dose depends on multiple factors. The goal of this study was to assess fluoroscopy time (FT), radiation doses and effective dose (ED) during ERCP according to the condition being treated. MATERIALS AND METHODS: a descriptive study was performed of 369 consecutive ERCPs from January 2017 to June 2019. Patient demographic and procedure data were collected. FT, cumulative dose area product (DAP), fluoroscopy DAP, DA fluoroscopy, air kerma, and number of radiographs were assessed. ED was estimated using specific conversion factors. RESULTS: the mean age was 73.34 years and 193 subjects were male. Mean FT was 4.56 ± 0.17 min, cumulative DAP was 2,056.73 ± 188.83 cGycm2, fluoroscopy DAP was 1,722.90 ± 82.26 cGycm2 and air kerma was 85.84 ± 4.93 mGy. The number of radiographs was 2.10 ± 0.07 and the mean ED was 5.34 ± 0.49 mSv. FT was significantly longer for choledocholithiasis (CL), proximal malignant biliary stricture (PMBS) and distal malignant biliary stricture (DMBS) versus others (OT). Cumulative DAP was higher for PMBS (p < 0.002). FT, cumulative DAP, fluoroscopy DAP and air kerma values were significantly higher for complicated CL as compared to simple CL. ED was higher for CL, DMBS and PMBS, but only significantly (p < 0.002) for PMBS. CONCLUSIONS: FT for ERCP is variable and increases with exploration difficulty. Thus, it is longer in the case of PMBS, as well as with the amount of radiation received by the patients and ED.

Prevalence and factors associated with poor sleep quality in inflammatory bowel disease outpatients.

INTRODUCTION: sleep disorders are common in the general population and have obvious repercussions on quality of life. Poor sleep quality is associated to inflammatory activity and fatigue in inflammatory bowel disease (IBD) patients. This study aimed to analyze the prevalence of poor sleep quality and the factors associated with it, in IBD outpatients. METHODS: an observational and prospective study was performed in which epidemiological, clinical and laboratory data were collected from clinical records and patients who consecutively attended an outpatient clinic. Pittsburgh Sleep Quality index (PSQI), Hospital Anxiety and Depression Scale (HADS) and International Physical Activity Questionnaire (IPAQ) were used to measure sleep quality, anxiety, depression and physical activity, respectively. Treatment optimizations, hospital admissions or surgery were prospectively verified three months after the baseline visit. RESULTS: one hundred and two patients were included and 54.9 % had poor sleep quality (PSQI score > 5). No association was found between poor sleep quality and IBD-related variables such as type of disease, ulcerative colitis (UC) extent, Crohn's disease (CD) location or behavior, time from diagnosis, treatment, prior admissions or surgery and laboratory values. Rotating night shift job (OR 6.116, 95 % CI: 1.312-28.514), HAD score for depression (OR 1.125, 95 % CI: 1.062-1.490) and frequency (days per week) of vigorous physical activity (OR 0.783, 95 % CI: 0.619-0.991) were independent predictors of poor sleep quality. A Pittsburgh questionnaire score higher than 5 was not significantly associated to treatment optimization in the total patient cohort (15.2 % vs 18.2 %, p = 0.451), in UC patients (18.2 % vs 10.7 %, p = 0.362) or CD patients (12.5 % vs 25.9 %, p = 0.198). CONCLUSIONS: poor sleep quality is present in more than half of IBD patients. Aspects not directly related to IBD are associated to poor sleep quality.

Hydration with Lactated Ringer's solution combined with rectal diclofenac in the prevention of pancreatitis after endoscopic retrograde cholangiopancreatography. / Hidratación con Ringer Lactato combinado con diclofenaco rectal en la prevención de pancreatitis poscolangiopancreatografía retrógrada endoscópica.

OBJECTIVE: Different measures are recommended to reduce pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). We conducted a study in patients with ERCP treated with rectal diclofenac or lactated Ringer's solution, or both interventions, to assess whether there is a decrease in the number of cases of post-ERCP pancreatitis. MATERIAL AND METHODS: A mixed cohort study involving 1,896 patients from 2009 to 2018. Up to June 2012 without treatment (Group I). Subsequently, 100mg of rectal diclofenac (Group II). Since 2016, lactated Ringer's solution 200ml/hour during the procedure and 4hours after it, in addition to 500ml over 30minutes when the pancreas was cannulated (Group III). Since 2017, lactated Ringer's solution plus Diclofenac (Group IV). There were 725 patients in group I, and 530, 227 and 414 patients in groups II, III and IV, respectively. Factors predisposing to post-ERCP pancreatitis and post-ERCP pancreatitis cases that were defined by consensus criteria have been collected. RESULTS: There were 65 cases of post-ERCP pancreatitis (3.4%); 2.9%, 3.4%, 3.1% and 4.3% in groups I, II, III and IV, respectively (P=.640). In group I, there was 4.2% of post-ERCP pancreatitis in naïve papillae and 4%, 4.9% and 6.3% in groups II, III and IV, respectively (P=.585). The severity of post-ERCP pancreatitis and adverse effects were similar in all groups. 38.4% were high-risk patients. There were also no differences in post-ERCP pancreatitis in this group (P=.501). CONCLUSION: In this work, no benefit was obtained with diclofenac plus hydration in reducing the number and severity of cases of post-ERCP pancreatitis nor with the other prophylactic measures.

Rectal diclofenac does not prevent post-ERCP pancreatitis in consecutive high-risk and low-risk patients.

OBJECTIVE: rectal diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that is used to prevent pancreatitis in high-risk patients during endoscopic retrograde cholangiopancreatography (ERCP). The European Society of Gastrointestinal Endoscopy (ESGE) recommends the use of prophylaxis with indomethacin or diclofenac in all patients undergoing ERCP, including those at low or intermediate risk of pancreatitis. A study to investigate the efficacy of this recommendation was performed. METHODS: this was a mixed cohort study. A total of 1,512 ERCP procedures performed in our institution from January 2009 to July 2016 were included in the study. Until June 2012, 718 patients did not receive diclofenac. Subsequently, 794 patients without contraindications received 100 mg of rectal diclofenac at the onset of the procedure. Risk factors for post-ERCP pancreatitis (PEAP) and PEAP cases defined using consensus criteria were recorded. RESULTS: a total of 47 PEAP events (3.1%) were reported, 3.4% in the diclofenac group and 2.8% in the non-diclofenac group (p = 0.554); 26.1% of patients had risk factors for PEAP. In the diclofenac group, PEAP developed in 4.4%, 0.5% and 2.6% of subjects with intact papillae, prior sphincterotomy and extended sphincterotomy, respectively. The results were similar for the non-diclofenac group: 4% with intact papillae, 0.9% with prior sphincterotomy, and 2.5% with extended sphincterotomy, respectively. PEAP severity was similar in both groups. CONCLUSIONS: rectal diclofenac before ERCP did not prevent the development of post-ERCP acute pancreatitis in non-selected consecutive patients.

Hepatocolic fistula managed with a novel Padlock® device for endoscopic closure.

Recent advances in endoscopic therapeutics allow conditions such as fistulas of the digestive system to be treated endoscopically. These cases were recently managed with surgery. The Padlock® system includes a nitinol clip that was recently introduced for endoscopic therapy. There are few reports with regard to its use in the daily clinical practice. We report a case of a colonic fistula that was endoscopically managed with this novel over-the-scope nitinol clip system.

Impact of the endoscopist's experience on the negative predictive value of capsule endoscopy. / Influencia de la experiencia acumulada del explorador en el valor predictivo negativo de la cápsula endoscópica.

INTRODUCTION: The impact of the accumulated experience of the capsule endoscopy (CE) reader on the accuracy of this test is discussed. AIM: To determine whether the negative predictive value of CE findings changes along the learning curve. METHODS: We reviewed the first 900 CE read by 3 gastroenterologists experienced in endoscopy over 8 years. These 900 CE were divided into 3 groups (300 CE each): group 1 consisted of the sum of the first 100 CE read by each of the 3 endoscopists; group 2, the sum of the second 100 and groups 3, the sum of the third 100. Patients with normal CE were monitored for at least 28 months to estimate the negative predictive value. RESULTS: A total of 54 (18%) CE in group 1, 58 (19.3%) in group 2 and 47 (15.6%) in group 3 were normal, although only 34 patients in group 1, 38 in group 2 and 36 in group 3 with normal CE completed follow up and were eventually studied. The negative predictive value was 88.2% in group 1, 89.5% in group 2 and 97% in group 3 (P>.05). CONCLUSION: The negative predictive value tended to increase, but remained high and did not change significantly after the first 100 when readers are experienced in conventional endoscopy and have preliminary specific training.

Aetiology and prevalence of post-colonoscopy colorrectal cancer. / Etiología y prevalencia de los cánceres colorrectales poscolonoscopia.

BACKGROUND: Colonoscopy is the gold standard for the detection and prevention of colorectal cancer (CRC). However, some individuals are diagnosed with CRC soon after a previous colonoscopy. AIMS: To evaluate the rate of new onset or missed CRC after a previous colonoscopy and to study potential risk factors. METHODS: Patients in our endoscopy database diagnosed with CRC from March 2004 to September 2011 were identified, selecting those with a colonoscopy performed within the previous 5years. Medical records included age, gender, comorbidities and colonoscopy indication. Tumour characteristics studied were localization, size, histological grade and TNM stage and possible cause. These patients were compared with those diagnosed with CRC at their first endoscopy (sporadic CRC-control group). RESULTS: A total of 712 patients with CRC were included; 24 patients (3.6%) had undergone colonoscopy within the previous 5 years (50% male, 50% female, mean age 72). Post-colonoscopy CRCs were attributed to: 1 (4.2%) incomplete colonoscopy, 4 (16.6%) incomplete polyp removal, 1 (4.2%) failed biopsy, 8 (33.3%) 'missed lesions' and 10 (41.7%) new onset CRC. Post-colonoscopy CRCs were smaller in size than sporadic CRCs (3.2cm vs. 4.5cm, P<.001) and were mainly located in the proximal colon (63% vs. 35%, P=.006); no difference in histological grade was found (P=.125), although there was a tendency towards a lower TNM stage (P=.053). CONCLUSIONS: There is a minor risk of CRC development after a previous colonoscopy (3.6%). Most of these (58.4%) are due to preventable factors. Post-colonoscopy CRCs were smaller and mainly right-sided, with a tendency towards an earlier TNM stage.

Need for therapeutic escalation in patients with refractory ulcerative proctitis: Results from the PROCU study of the ENEIDA registry.

BACKGROUND: Ulcerative proctitis (UP) can have a milder, less aggressive course than left-sided colitis or extensive colitis. Therefore, immunosuppressants tend to be used less in patients with this condition. Evidence, however, is scarce because these patients are excluded from randomised controlled clinical trials. Our aim was to describe the characteristics of patients with refractory UP and their disease-related complications, and to identify the need for immunosuppressive therapies. METHODS: We identified patients with UP from the prospective ENEIDA registry sponsored by the GETECCU. We evaluated socio-demographic data and complications associated with immunosuppression. We defined immunosuppression as the use of immunomodulators, biologics and/or small molecules. We used logistic regression to identify factors associated with immunosuppressive therapy. RESULTS: From a total of 34,716 patients with ulcerative colitis, we identified 6281 (18.1%) with UP; mean ± SD age 53 ± 15 years, average disease duration of 12 ± 9 years. Immunosuppression was prescribed in 11% of patients, 4.2% needed one biologic agent and 1% needed two; 2% of patients required hospitalisation, and 0.5% underwent panproctocolectomy or subtotal colectomy. We identified 0.2% colorectal tumours and 5% extracolonic tumours. Patients with polyarthritis (OR 3.56, 95% CI 1.86-6.69; p < 0.001) required immunosuppressants. CONCLUSIONS: Among patients with refractory UP, 11% required immunosuppressant therapy, and 4.2% required at least one biologic agent.

[Meckel's diverticulum and enteroliths complicating Crohn's disease]. / Divertículo de Meckel y enterolitos como complicación de la enfermedad de Crohn.

We describe the case of a 43-year-old man recently diagnosed with ileal Crohn's disease complicated by a free peritoneal perforation of a Meckel's diverticulum and the presence of enteroliths in the intestinal lumen. The coexistence of Crohns disease, Meckel's diverticulum and enteroliths has rarely been reported. Meckel's diverticulum can hamper the management of Crohn's disease.

Long-Term Real-World Effectiveness and Safety of Ustekinumab in Crohn's Disease Patients: The SUSTAIN Study.

BACKGROUND: Large real-world-evidence studies are required to confirm the durability of response, effectiveness, and safety of ustekinumab in Crohn's disease (CD) patients in real-world clinical practice. METHODS: A retrospective, multicentre study was conducted in Spain in patients with active CD who had received ≥1 intravenous dose of ustekinumab for ≥6 months. Primary outcome was ustekinumab retention rate; secondary outcomes were to identify predictive factors for drug retention, short-term remission (week 16), loss of response and predictive factors for short-term efficacy and loss of response, and ustekinumab safety. RESULTS: A total of 463 patients were included. Mean baseline Harvey-Bradshaw Index was 8.4. A total of 447 (96.5%) patients had received prior biologic therapy, 141 (30.5%) of whom had received ≥3 agents. In addition, 35.2% received concomitant immunosuppressants, and 47.1% had ≥1 abdominal surgery. At week 16, 56% had remission, 70% had response, and 26.1% required dose escalation or intensification; of these, 24.8% did not subsequently reduce dose. After a median follow-up of 15 months, 356 (77%) patients continued treatment. The incidence rate of ustekinumab discontinuation was 18% per patient-year of follow-up. Previous intestinal surgery and concomitant steroid treatment were associated with higher risk of ustekinumab discontinuation, while a maintenance schedule every 12 weeks had a lower risk; neither concomitant immunosuppressants nor the number of previous biologics were associated with ustekinumab discontinuation risk. Fifty adverse events were reported in 39 (8.4%) patients; 4 of them were severe (2 infections, 1 malignancy, and 1 fever). CONCLUSIONS: Ustekinumab is effective and safe as short- and long-term treatment in a refractory cohort of CD patients in real-world clinical practice.

This large retrospective study demonstrated the short- and long-term effectiveness and safety of ustekinumab in patients with Crohn's disease in real-world clinical practice, including those with refractory disease.

Using Interpretable Machine Learning to Identify Baseline Predictive Factors of Remission and Drug Durability in Crohn's Disease Patients on Ustekinumab.

Ustekinumab has shown efficacy in Crohn's Disease (CD) patients. To identify patient profiles of those who benefit the most from this treatment would help to position this drug in the therapeutic paradigm of CD and generate hypotheses for future trials. The objective of this analysis was to determine whether baseline patient characteristics are predictive of remission and the drug durability of ustekinumab, and whether its positioning with respect to prior use of biologics has a significant effect after correcting for disease severity and phenotype at baseline using interpretable machine learning. Patients' data from SUSTAIN, a retrospective multicenter single-arm cohort study, were used. Disease phenotype, baseline laboratory data, and prior treatment characteristics were documented. Clinical remission was defined as the Harvey Bradshaw Index ≤ 4 and was tracked longitudinally. Drug durability was defined as the time until a patient discontinued treatment. A total of 439 participants from 60 centers were included and a total of 20 baseline covariates considered. Less exposure to previous biologics had a positive effect on remission, even after controlling for baseline disease severity using a non-linear, additive, multivariable model. Additionally, age, body mass index, and fecal calprotectin at baseline were found to be statistically significant as independent negative risk factors for both remission and drug survival, with further risk factors identified for remission.