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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., Trial Registration: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home., (© 2023. The Author(s).)

Goals: To analyze the pleural fluid factors that might cause spontaneous bacterial empyema (SBEM) in patients with cirrhotic hydrothorax., Background: Pathogenic mechanism of SBEM of cirrhotic patients is probably similar to that of spontaneous bacterial peritonitis, but local factors affecting pleural fluid have not been studied., Study: Determination of C3, C4, and opsonic activity levels of pleural fluid in a cohort of patients with pleural effusions of different causes., Results: Forty-eight patients had hepatic hydrothorax; 8, heart failure and 45, exudates (9, tuberculosis; 21, malignancies; 10, other). Of the 48 cirrhotic patients, 15 developed SBEM on admission. The pleural fluid of cirrhotic patients showed significantly lower levels of total protein, complement, and opsonic activity than did the fluids of patients with other causes of SBEM. Patients who developed SBEM had lower concentrations of pleural fluid total protein and C3 and had a higher Child-Pugh score than patients who did not develop the infection., Conclusion: Cirrhotic patients with hepatic hydrothorax have lower pleural fluid opsonic activity and C3 levels than those found in the pleural fluid of patients with other causes. Patients who develop SBEM have lower levels of pleural fluid C3, pleural fluid total protein, and a higher Child-Pugh score than those who do not develop SBEM.