Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial

Crohn Disease; Self expandable metallic stents; Gastric dilatationEnfermedad de Crohn; Stents metálicos autoexpandibles; Dilatación gástricaMalaltia de Crohn; Pròtesis de stent; Dilatació gàstricaBackground: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. Methods/design: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. Discussion: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD.This study received a grant (FSEED; ) from the Spanish Society of Digestive Endoscopy in 2022. Taewoong provided the stents for the study free of charge, but had no role in the study design, data collection, data analysis, data interpretation, or writing of the report

Half of the patients with subepithelial tumours present borderline or pathologic anxiety-distress and carcinophobia: multicentre cohort study

Background and aims: minor nonspecific gastrointestinal sub-epithelial lesions (usually defined by the term 'tumor') are usually associated with a malignant illness and cancer. The aim of this study was to assess anxiety-distress and carcinophobia in patients referred to specialized monographic outpatient clinics for evaluation and treatment of this type of lesion.Methods: prospective, multicenter, cohort study. Specific self-reported questionnaires were used to report threat-ening life-experiences and to assess levels of distress (The Hospital Anxiety and Depression Scale) and cancer-related worries (The Cancer Worry Scale).Results: forty participants were included and analyzed at baseline. Pathologic and borderline anxiety were detected in 13 % (5/40, 95 % CI: 4-27 %) and 35 % (14/40, 95 % CI: 21-52 %) of participants, respectively, whereas, cancer-relat-ed worries (moderate to very high) were observed in 48 % (19/40, 95 % CI: 32-64 %) of participants. Pathologic global distress was identified in 25 % (10/40, 95 % CI: 13-42 %) of subjects. Higher educational level (university studies), a lack of lifetime psychiatric comorbidity and a lack of family history of cancer were associated with less anxiety, global distress and carcinophobia.Conclusions: almost half of the patients diagnosed with a minor nonspecific gastrointestinal subepithelial lesion pre-sented anxiety-distress and/or carcinophobia. Specific associ-ations with anxiety-distress reaction and fears were detected

Intestinal intraepithelial lymphocyte cytometric pattern is more accurate than subepithelial deposits of anti-tissue transglutaminase IgA for the diagnosis of celiac disease in lymphocytic enteritis

Background & Aims: An increase in CD3+TCRγδ+ and a decrease in CD3− intraepithelial lymphocytes (IEL) is a characteristic flow cytometric pattern of celiac disease (CD) with atrophy. The aim was to evaluate the usefulness of both CD IEL cytometric pattern and anti-TG2 IgA subepithelial deposit analysis (CD IF pattern) for diagnosing lymphocytic enteritis due to CD. Methods: Two-hundred and five patients (144 females) who underwent duodenal biopsy for clinical suspicion of CD and positive celiac genetics were prospectively included. Fifty had villous atrophy, 70 lymphocytic enteritis, and 85 normal histology. Eight patients with non-celiac atrophy and 15 with lymphocytic enteritis secondary to Helicobacter pylori acted as control group. Duodenal biopsies were obtained to assess both CD IEL flow cytometric (complete or incomplete) and IF patterns. Results: Sensitivity of IF, and complete and incomplete cytometric patterns for CD diagnosis in patients with positive serology (Marsh 1+3) was 92%, 85 and 97% respectively, but only the complete cytometric pattern had 100% specificity. Twelve seropositive and 8 seronegative Marsh 1 patients had a CD diagnosis at inclusion or after gluten free-diet, respectively. CD cytometric pattern showed a better diagnostic performance than both IF pattern and serology for CD diagnosis in lymphocytic enteritis at baseline (95% vs 60% vs 60%, p = 0.039). Conclusions: Analysis of the IEL flow cytometric pattern is a fast, accurate method for identifying CD in the initial diagnostic biopsy of patients presenting with lymphocytic enteritis, even in seronegative patients, and seems to be better than anti-TG2 intestinal deposits

Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction - BAMPI TRIAL: an open-label, randomized controlled trial protocol

Background It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. Methods/design This is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). Discussion The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction

Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.

Background: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. Methods/design: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. Discussion: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD

Prevalença de la infecció pel virus de la hepatitis B i C en pacients amb malaltia inflamatòria intestinal. Impacte del tractament immunosupressor en l’evolució de l’hepatopatia

INTRODUCCIÓ: Hi ha molt poca informació a la literatura mèdica que suggereix que existeix una alta prevalença de la infecció pel virus hepatitis B (VHB) i C (VHC) en malalts amb malaltia inflamatòria intestinal (MII). El seu coneixement és important per la possibilitat de reactivació viral relacionada amb el tractament immunosupressor. HIPÒTESI: La infecció per VHB i C és més freqüent en la MII que en la població general de referència. El tractament immunosupressor pot reactivar la infecció per VHB i C. OBJECTIUS: Avaluar: 1) La prevalença d'infecció per VHB i C en pacients amb MII de diferents àrees geogràfiques d'Espanya. 2) L'efecte del tractament immunosupressor i els fàrmacs biològics sobre l'evolució de la infecció per VHB i C. METODOLOGIA: Estudi 1: inclusió de 2076 pacients amb MII, als quals s'avalua l'existència d'infecció per VHB i C mitjançant tècniques analítiques estàndard (ELISA i PCR). Es van registrar els factors relacionats amb la MII i la infecció. Estudi 2: Inclusió de 162 pacients amb MII i infecció per VHB i / o C i que van rebre tractament immunosupressor per la MII. Es van registrar variables clíniques i analítiques relacionades amb la reactivació. Tots dos són estudis multicèntrics amb registre electrònic (www.repentina.com). Per a l’anàlisi de resultats es van utilitzar tests univariants (2 i test de t Student) i multivariants (regressió logística i model de risc proporcional de Cox). RESULTATS: Estudi 1: El 9.7% de pacients amb colitis ulcerosa (CU) i malaltia de Crohn (MC) van presentar positivitat de marcadors d'infecció pel VHB i C actual o passada (CU: HBsAg 0.8 % , anti-HBc 8 % , anti-VHC 1.3 % ; MC: HBsAg 0.6 % , anti-HBc 7.1 % , anti-VHC 2.3 % ). El 12% de pacients amb MII van presentar marcadors de vacunació eficaç. En l’anàlisi multivariant, l'edat, la història familiar d'hepatitis i la MII moderada-greu, es van relacionar de manera significativa amb el VHB, mentre que les transfusions i l'ús d'antibiòtics ho van fer amb el VHC. Estudi 2: Un 36% de pacients van presentar disfunció hepàtica (DH) relacionada amb el VHB, un 66% dels quals van presentar insuficiència hepàtica. L’anàlisi multivariant va demostrar que l’únic factor relacionat amb la DH per VHB va ser l'ús simultani de 2 o més immunosupressors. En canvi només un 15.7% dels pacients amb VHC van presentar DH. CONCLUSIONS:Estudi 1: El pacients amb MII presenten una prevalença d’infecció pels VHB i VHC similar a la de la població general de referència, i aquesta és més baixa del que prèviament s’havia publicat. L’escassa relació de la infecció pel VHC i VHB amb els procediments invasius i ingressos hospitalaris suggereix que aquestes infeccions rarament s’adquireixen en l’àmbit hospitalari al nostre país. Es detecta un baix percentatge de vacunació eficaç pel VHB, el que obliga a intensificar els programes de vacunació en aquests pacients. Estudi 2: La DH en pacients amb MII tractats amb immunosupressors, és més freqüent i greu en els pacients amb infecció pel VHB que en el pacients amb infecció pel VHC. La immunosupressió combinada va ser l’únic factor predictiu independent de reactivació pel VHB.Background: Limited information suggests the existence of a high prevalence of hepatitis B (HBV) and C virus (HCV) in inflammatory bowel disease (IBD). Hypothesis: HBV and HCV infection is more common in IBD than in the general population. Immunosuppressants can reactivate these infections.Objectives: To asses: 1) the prevalence of HBV and HCV in IBD, in a nationwide study, and to evaluate associated risk factors. 2) the influence of immunosuppressants on the course of HBV and HCV in IBD.Methods: Study 1: inclusion of 2076 IBD patients, which evaluates the existence of HBV and HCV using ELISA and PCR. Factors related to IBD and to infection were registered. Study 2: Inclusion of 162 IBD patients with HBV and HCV infection and immunosuppressants. Registration of clinical and laboratory variables related to reactivation. Both are multicentre studies with electronic data base (www.repentina.com). The results are analyzed by univariate and multivariate analysis. Results: Study 1: Present and / or past HBV and HCV infection was found in 9.7 % of IBD patients (HBsAg 0,6-0,8% / antiHBc 7-8% / anti-HCV 1.3-2.3%). Effective vaccination was present in 12 % of patients. In multivariate analysis, age, family history of hepatitis and moderate-to-severe IBD were significantly associated with HBV, whereas transfusions and antibiotics were significantly associated with HCV. Study 2: Liver dysfunction (LD) was observed in 36% HBsAg positive patients, 66% of whom developed hepatic failure. In contrast LD in HCV was observed in 15.7% of HCV-RNA positive patients. Treatment with ≥2 immunosuppressants was an independent predictor of HBV reactivation.Conclusions: Study 1: Prevalence of HBV and HCV infection in IBD is similar to that of the general population and lower than that in previously published series. This fact, in addition to the lack of association with invasive procedures, suggests the existence of adequate preventive measures in centres attending to these patients. The low percentage of effective vaccination makes it mandatory to intensify B virus vaccination in IBD. Study 2: LD in patients with IBD treated with immunosuppressants is more frequent and severe in those with HBV than in HCV carriers and is associated with combined immunosuppression