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BACKGROUND: Anti-TNF agents are the only effective biological agents for the prevention of postoperative recurrence (POR) in Crohn's disease (CD). However, they are contraindicated or have been shown to fail in some patients. Although ustekinumab and vedolizumab were licensed for CD some years ago, data in this setting are scarce.; METHODS: All CD patients in whom ustekinumab or vedolizumab was prescribed for the prevention of POR within three months of ileocolonic resection with anastomosis were identified from the ENEIDA registry. The development of endoscopic, clinical and surgical POR was registered.; RESULTS: Forty patients were treated for the prevention of POR with ustekinumab and 25 were treated with vedolizumab. Eighty per cent had at least one risk factor for POR (prior resections, active smoking, perianal disease or penetrating disease behaviour). All the patients had been exposed to anti-TNF therapy. After a median follow-up of 17 and 26 months, the cumulative probability of clinical POR at 12 months after surgery was 32% and 30% for ustekinumab and vedolizumab, respectively. Endoscopic assessment within the first 18 months after surgery was available for 80% of the patients on ustekinumab and 70% for those on vedolizumab. The rate of endoscopic POR was 42% for ustekinumab and 40% for vedolizumab. One patient treated with ustekinumab and two with vedolizumab underwent a new intestinal resection.; CONCLUSIONS: Ustekinumab and vedolizumab seem to be effective in the prevention of POR in patients at high risk. Our results warrant controlled trials comparing these drugs with conventional therapies. Copyright © 2022. Published by Elsevier Ltd.

Background The adenoma detection rate (ADR) is the most important marker of colonoscopy quality. Devices to improve adenoma detection have been developed, such as the Endocuff and transparent cap. The aim of the current study was to examine whether there was a difference in ADR between Endocuff-assisted (EAC) and cap-assisted colonoscopy (CAC). Methods A randomized prospective trial was conducted. Eligible patients included adults ≥ 18 years referred because of symptoms, surveillance, or colonoscopies as part of the Bowel Cancer Screening Programme (BCSP). The primary outcome measure was ADR. Secondary outcomes included mean number of adenomas, mean number of polyps, polyp detection rate, cecal intubation rate, and time to cecal intubation. Procedural measures, device removal rate, and adverse events were also recorded. Results A total of 711 patients (51.1 % men; median age 63 years) were included, of whom 357 patients were randomized to EAC and 354 patients to CAC. In the intention-to-treat analysis, the ADR was similar in both groups: EAC 50.4 % (95 % confidence interval [CI] 45.1 – 55.7) vs. CAC 50.6 % (95 %CI 45.2 – 55.9). Similar results were obtained in the per-protocol analysis: EAC 51.6 % (95 %CI 46.2 – 57) vs. CAC 51.4 % (95 %CI 46 – 56.8). There were no differences between the two devices in ADR according to the mean number of adenomas and polyps per procedure, polyp detection rate, cecal intubation rate, and time to cecal intubation. Device removal rate and adverse events were also similar. Conclusion In this randomized study, no differences in ADR were found between Endocuff- and cap-assisted colonoscopy.

Aim To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. Methods Patients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score [PMS]. Short-term response/remission was assessed at Weeks 4, 8, and 16. Results A total of 113 patients were included. They were exposed to tofacitinib for a median time of 44 weeks. Response and remission at Week 8 were 60% and 31%, respectively. In multivariate analysis, higher PMS at Week 4 (odds ratio [OR] = 0].2; 95% confidence interval [CI] = 0].1–0.4) was the only variable associated with lower likelihood of achieving remission at Week 8. Higher PMS at Week 4 [OR = 0.5; 95% CI = 0.3–0.7] and higher PMS at Week 8 [OR = 0.2; 95% CI = 0.1–0.5] were associated with lower probability of achieving remission at Week 16. A total of 45 patients [40%] discontinued tofacitinib over time. Higher PMS at Week 8 was the only factor associated with higher tofacitinib discontinuation [hazard ratio = 1.5; 95% CI = 1.3–1.6]. A total of 34 patients had remission at Week 8; of these, 65% had relapsed 52 weeks after achieving remission; the dose was increased to 10 mg/12 h in nine patients, and five of them reached remission again. Seventeen patients had adverse events. Conclusions Tofacitinib is effective and safe in UC patients in real practice, even in a highly refractory cohort. A relevant proportion of patients discontinue the drug over time, mainly due to primary failure.

Background Patients with mNSCLC benefit in terms PFS and OS of treatment with immunotherapy (IO) in first (1L) and second line (2L); However, the majority of patients do not respond to IO, which, due to the high cost of these new treatments, makes identifying predictive factors of response imperative in order to select the patients who will really respond to this therapy. Bearing in mind that most hospitals do not have the technology to perform high sensitivity techniques such as NGS, it seems prudent to be able to identify these patients using more common, cheap and affordable methods in any hospital. Methods In all mNSCLC treated with IO in monotherapy in two university hospitals in Spain, from February 2012 to January 2018, a RWD study of predictive factors of response was performed. 198 patients from the University Hospital Arnau de Vilanova of Lleida and the University Hospital Dr. Josep Trueta (ICO Girona) were analyzed. Statistical analysis of the data was performed using IBM SPSS Statistics 23.0 software. Results With a median follow-up from the start of treatment with IO of 217 days, it was found that in all treated patients, the overall response rate (ORR = CR + PR) was 26.6%. In 1L the ORR was 56%, in 2L 22.8%, in 3L 15% and in 4L 0%. In 1L, the factor that is associated with a better response is the absence of liver mets: ORR 66.7% vs 16.7% (p: 0.03). The factor associated with a better OS is Hb ≥ 12.5 gr/dl (p 0.001): 495 vs 241 days. Analyzing by treatment lines, we objectify that in 1L, the factors that influence better OS are the absence of liver mets (p 0.003): 421 (CI: 345-497) vs 138 days (CI: 65-212) ) and Hb ≥ 12.5gr dl (p 0.027) 440 (CI: 368-512) vs 215 days (CI: 111-319). In 2L the factors that influence a better OS are younger age with a cutoff point of 70 years (p 0.008): 328 vs 239 days; Hb ≥ 12.5 gr/dl (p 0.001): 512 vs 325 days and lymphocytes > 1450 (p 0.013): 353 vs 241 days. Conclusions Methods that are easily available in any hospital can help select the patients that benefit most from immunotherapy in monotherapy. In our series, patients older than 70 years, with Hb ≤ 12.5 gr/dl and lymphocytes ≤1.450, have worse overall survival independently of PDL1. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

The aim of this study was to determine the main diagnostic validity parameters of a quantitative real-time polymerase chain reaction (PCR) system for detecting Helicobacter pylori in gastric biopsies. Prospective study. The real-time PCR has an internal control for eliminating the false negatives. Our system has a good diagnostic capacity compared with the gold standard and was superior in antral mucosa: area under the curve was 0.91 for antrum (95% confidence interval [CI] 0.87 to 0.96) and 0.83 for corpus (95% CI 0.77 to 0.9). The optimum cut-off point was 3.56 microorganisms/cell for antrum (sensitivity 83.5% [95% CI 74.2 to 89.9]; specificity 91.3% [95% CI 82.3 to 96.0]; positive predictive value 92.2%; negative predictive value 81.8%). The positive likelihood ratios were 9.61 and 8.52 for antrum and corpus, respectively. With the cut-off point that maximises the Youden index, 8.7% false positives were obtained. Our methodology is useful for diagnosing infection due to H. pylori and the false positives detected probably correspond to patients who were actually infected but the infection was not detected by traditional techniques. The clinical importance of these cases should be studied in greater detail since they may involve colonisations unrelated to the patient's digestive pathology.

A 58-year-old man diagnosed with ileocolonic Crohn disease was admitted to the emergency room with massive lower gastrointestinal hemorrhage and hypovolemic shock. Treatment was started with methylprednisolone, metronidazole and omeprazole. Within the next 24 hours, he received a total of 9 U of red blood cell concentrate and 2 U of fresh frozen plasma. Because of persistence of bleeding, hypovolemic shock and life-threatening situation, we started therapy with rFVIIa. One dose of 120 microg/kg and another dose of 120 microg/kg three hours after the first dose were administered as compassionate use, with resolution of bleeding in the next 12 hours. On day 4 the patient was stabilized. We performed a total colonoscopy and intubation of the ileocecal valve that showed patchy deep ulcerations in the rectum with bleeding inflammatory pseudopolyps. Acute gastrointestinal bleeding is an unusual complication in Crohn disease. In this case, the use of recombinant activated factor VIIa controlled the massive gastrointestinal bleeding secondary to Crohn disease and without clinically significant adverse effect. There are few case reports documenting the use of recombinant activated factor VIIa for this type of off-label indication. Clinical trials should be carried out to define the dosage and dose interval schedule of rFVIIa in the treatment of uncontrolled massive gastrointestinal bleeding secondary to Crohn disease.

Presented in part as a poster at 2005 Meeting EASL, Paris., Studies of the pathogenesis of hepatic encephalopathy are hampered by the lack of a satisfactory animal model. We examined the neurological features of rats after bile duct ligation fed a hyperammonemic diet (BDL+HD). Six groups were studied: sham, sham pair-fed, hyperammonemic, bile duct ligation (BDL), BDL pair fed, and BDL+HD. The BDL+HD rats were made hyperammonemic via an ammonia-containing diet that began 2 weeks after operation. One week later, the animals were sacrificed. BDL+HD rats displayed an increased level of cerebral ammonia and neuroanatomical characteristics of hepatic encephalopathy (HE), including the presence of type II Alzheimer astrocytes. Both BDL and BDL+HD rats showed activation of the inflammatory system. BDL+HD rats showed an increased amount of brain glutamine, a decreased amount of brain myo-inositol, and a significant increase in the level of brain water. In coordination tests, BDL+HD rats showed severe impairment of motor activity and performance as opposed to BDL rats, whose results seemed only mildly affected. In conclusion, the BDL+HD rats displayed similar neuroanatomical and neurochemical characteristics to human HE in liver cirrhosis. Brain edema and inflammatory activation can be detected under these circumstances., Supported by grants from Instituto de Salud Carlos III, Convocatoria de RedesTematicas (G03/155 and C03/02); Conselleria de Sanitat, Escuela Valenciana para Estudios de la Salud (BM-004/2002); Organisme Public Valencia d’Investigacio, Ajudes per a Accions Especials (21-2002), Generalitat Valenciana,GV Grupos 03/053, Junta de Comunidades de Castilla-La Mancha (GC-02-022)and Instituto de Salud Carlos III (PI03/0576).

OBJECTIVE To report a probable case of Henoch-Schönlein purpura associated with acenocoumarol therapy. CASE SUMMARY A 76-year-old white woman was prescribed acenocoumarol for chronic atrial fibrillation. Two months after starting therapy, the patient came to our hospital's emergency department because of abdominal pain associated with vomiting. Physical examination revealed multiple round, confluent, purpuric lesions with some vesicles and an area of residual pigmentation. Lesions were present predominantly on the legs and gluteus, and also on the abdomen and arms. Skin biopsy of the lesions was compatible with leukocytoclastic vasculitis with deposition of immunoglobulin A. An upper intestinal endoscopy was done and identified purpuric mucosal lesions in the fundus, body, and antrum of the stomach and the duodenal bulb. Renal function was not affected, although proteinuria (1.26 g/day) was found and microscopic hematuria was observed. DISCUSSION The most likely cause of the Henoch–Schönlein purpura in this case was considered to be acenocoumarol because of the close temporal relationship between exposure to the drug and onset of symptoms, as well as the rapid resolution of the symptoms and signs after acenocoumarol was discontinued. The oral anticoagulant was the only identifiable precipitant that the patient encountered before the Henoch–Schönlein purpura developed. An objective causality assessment revealed that the adverse drug event was probable. CONCLUSIONS This case report illustrates a probable association between Henoch–Schönlein purpura and acenocoumarol. As of December 2003, this reaction had not been previously reported. Clinicians should be aware of this potential adverse effect of a widely used drug.

BACKGROUND Various studies and two meta-analysis have shown that a variable stiffness colonoscope improves cecal intubation rate. However, there are few studies on how this colonoscope should be used. OBJECTIVE The aim of this study was to identify factors related to the advancement of the colonoscope when the variable stiffness function is activated. METHODS Prospective study enrolling consecutive patients referred for colonoscopy. The variable stiffness colonoscope (Olympus CF-H180DI/L®) was used. We performed univariate and multivariate analyses of factors associated with the success of the variable stiffness function. RESULTS After the data inclusion period, 260 patients were analyzed. The variable stiffness function was used most in the proximal colon segments (ascending and transverse colon 85%; descending/sigmoid colon 15.2%). The body mass index was lower in patients in whom the endoscope advanced after activating the variable stiffness than those in which it could not be advanced (25.9 + or - 4.8 vs. 28.3 + or - 5.4 kg/m2, p = 0.009). The endoscope advanced less frequently when the stiffness function was activated in the ascending colon versus activation in other segments of the colon (25% vs. 64.5% ascending colon vs. other segments; p < 0.05). In the multivariate analysis, only the colon segment in which the variable stiffness was activated was an independent predictor of advancement of the colonoscope. CONCLUSIONS The variable stiffness function is effective, allowing the colonoscope advancement especially when applied in the transverse colon, descending colon and sigmoid. However, when used in the ascending colon it has a lower effectiveness.

The aim of this study was to determine the diagnostic usefulness of quantification of the H. pylori genome in detection of infection in patients with upper gastrointestinal bleeding (UGB). A total of 158 consecutive patients with digestive disorders, 80 of whom had clinical presentation of UGB, were studied. The number of microorganisms was quantified using a real-time PCR system which amplifies the urease gene with an internal control for eliminating the false negatives. A biopsy sample from the antrum and corpus of each patient was processed. The rapid urease test, culture, histological study, stool antigen test, and breath test were done. The gold standard was a positive culture or positive results in at least two of the other techniques. When a positive result was defined as any number of microorganisms/human cell, the sensitivity of real-time PCR was greater in bleeding patients, especially in the gastric corpus: 68.4% (95% confidence interval [CI], 52.3 to 84.5%) in non-UGB patients versus 91.5% (95% CI, 79.6 to 97.6%) in UGB patients. When a positive result was defined as a number of microorganisms/human cell above the optimal value that maximizes the Youden index (>3.56 microorganisms/human cell in the antrum and >2.69 in the corpus), the sensitivity and specificity in UGB patients were over 80% in both antrum and corpus. Our findings suggest that some bleeding patients with infection caused by H. pylori may not be correctly diagnosed by classical methods, and such patients could benefit from the improved diagnosis provided by real-time PCR. However, the clinical significance of a small number of microorganisms in patients with negative results in classical tests should be evaluated.

Introduction Variable stiffness colonoscope may be useful in performing colonoscopies in nonsedated patients or under endoscopist-controlled sedation. The objective of this study is to evaluate whether this instrument facilitates colonoscopy in patients under deep sedation monitored by an anaesthesiologist. Methods Prospective and randomized study enroling consecutive patients referred for colonoscopy under deep sedation monitored by an anaesthesiologist. In group I, a variable stiffness colonoscope was used, whereas in group II, a standard colonoscope was used. The main variable was the need to change the position of the patient during the endoscopy. Results Fifty-six patients were included in group I (variable stiffness colonoscope) and 54 in group II (standard colonoscope). The caecum was reached in 92.9% of patients in group I and in 90.7% of group II (P=0.7). The time required to reach the caecum was significantly less in group I (6.14±3.5 vs. 7.7±3.8; P=0.035). The variable stiffness colonoscope was effective in 66.7% of cases. Changing the position of the patient was necessary in 12.5% of cases in group I compared with 33.3% of cases in group II (P=0.01). Conclusion The variable stiffness colonoscope avoids the need to change the patient's position and reduces caecal intubation time in patients undergoing colonoscopy under deep sedation controlled by an anaesthesiologist.

Non-attendance at endoscopy procedures leads to wasted resources and increased costs. The purpose of this study was to investigate the factors associated with non-attendance.All patients who attended the outpatient clinic for gastroscopy or colonoscopy examinations were included in the study. Patients who missed their appointment were identified and their data were collected prospectively. Patients who kept their appointment in the same period of time served as controls.Between August 2002 and February 2003, 1051 gastroscopies and 756 colonoscopies were scheduled. A total of 265 patients (14.7%) missed their appointment. No significant differences were found between attendees and non-attendees for mean age, gender, type of examination and day of the week on which the examination was scheduled. The time on the waiting list was longer in patients who did not keep their appointment than in those who did. Fewer appointments were missed in patients with a preferent referral, and among patients referred by their general practitioner a higher percentage failed to keep their appointment compared with those referred by a specialist. In the multivariate analysis, length of time on the waiting list and the source of referral were the only two independent predictive factors for non-attendance.A longer time on the waiting list and referral by a general practitioner are factors associated with patients failing to keep their endoscopy appointment.

La displasia gastrica puede ser seguida y tratada mediante endoscopia. Han sido diversas las tecnicas descritas para dicho fin. Se aporta el caso de un paciente varon de 70 anos que presentaba anemia, anorexia, debilidad y perdida de peso. La gastroscopia y la biopsia demostraron la presencia, de una displasia gastrica severa, realizandose reseccion cromoendos-copica de la misma. El paciente se encuentra asintomatico un ano despues, recuperado de la anemia. Uno de los controles endoscopicos recientes revelo la presencia de una displasia leve en el area cercana a la reseccion previa. Se discuten las ventajas e inconvenientes de esta tecnica.

The dysfunction of the intestinal barrier is a factor that has been related to bacterial translocation from lumen to extra-intestinal sites and consequently to the development of spontaneous bacterial peritonitis. The aim of this study was to investigate if the alterations of the intestinal barrier in cirrhosis are related with the degree of liver failure and associated with other clinical complications.Intestinal permeability was assessed by means of the lactulose/mannitol test in 79 cirrhotic and 25 controls subjects. They received 10 g of lactulose and 5 g of mannitol. Lactulose and mannitol were measured in a five-hour urinary volume.Lactulose/mannitol ratio was significantly higher in cirrhotic patients than in controls (p = 0.03). This was more evident in end-stage cirrhosis. Patients with ascites, or encephalopathy showed a statistically significant increase in lactulose/mannitol ratio when compared to patients without these complications.The increased intestinal permeability is related to the progression of the liver disease and is more relevant with overt clinical complications. This is due to an increased absorption of lactulose. However, as liver disease progresses, mannitol absorption is progressively reduced, probably due to a reduced surface of absorption, and these events are more relevant in patients with overt clinical complications.

Objectives Two types of neurological dysfunction can occur in compensated cirrhosis: 1) extrapyramidal signs related to the accumulation of manganese in the basal ganglia and 2) milder degrees of cognitive impairment known as minimal hepatic encephalopathy (mHE). We assessed whether there was any relationship between both disorders in 42 patients with compensated cirrhosis. Methods Minimal hepatic encephalopathy was diagnosed using a battery of manual neuropsychological tests. Cognitive functioning was assessed by the Mini-Mental State Examination. Extrapyramidal signs were evaluated by the Columbia scale. Results Minimal hepatic encephalopathy was diagnosed in 15 (35.7%) patients. A total of 52.4% of patients showed significant extrapyramidal signs. Scores for the Columbia scale were higher in the presence of mHE (mean ± SD, 16.0 ± 10.9 vs 5.3 ± 7.1, p = 0.0004). In the bivariate analysis, mHE, Child-Pugh score, and Mini-Mental State Examination score were significantly associated with extrapyramidal signs, whereas in the multivariate analysis, mHE was the only independent variable related to extrapyramidal signs. Conclusions There was a link between extrapyramidal signs and diagnosis of mHE based on manual neuropsychological testing. This finding may be explained by the influence of extrapyramidal manifestations on test performance or by a real pathophysiological relationship between both disorders. Further studies are necessary to resolve this question.

Norfloxacin prophylaxis decreases the incidence of bacterial infections in high-risk cirrhotic patients, but may promote the development of quinolone-resistant gram-negative bacteria in stools, and eventually lead to infections due to these bacteria. The aim of the study was to evaluate the prevalence of quinolone-resistant strains of E. coli in stools on admission, and the characteristics of any nosocomial infections.Eighty-three consecutively hospitalized cirrhotic patients were included in this prospective study. The presence of quinolone-resistant strains of E. coli in stools on admission, and the characteristics of any nosocomial infections were recorded.Fourteen out of 83 patients (16.8%) showed quinolone-resistant E. coli in stools (Group I), and 69 did not (Group II). Thirteen out of 14 from Group I (92.8%) and 17/69 (24.6) from Group II had received primary or secondary prophylaxis with norfloxacin (p0.001). During hospitalization, 12/12 (100%) of patients from Group I and 25/66 (37.8%) of patients from Group II underwent norfloxacin prophylaxis. Three bacterial infections in patients from Group I, 3 from Group II patients receiving norfloxacin and 16 from Group II patients not receiving norfloxacin were recorded (p0.05). No infections due to quinolone-resistant E. coli were observed in patients colonized with these bacteria. Treatment with norfloxacin induced the development of quinolone-resistant E. coli in 6/14 (42.8%) patients in a mean time of 18.5+/-9.8 days.The development of quinolone-resistant strains of E. coli is significantly associated with previous administration of norfloxacin prophylaxis. However, in our series this fact is not associated with an increased incidence of quinolone-resistant E. coli or other gram-negative infections.