Stenting for rectal carcinoma is technically feasible and safe, and probably reduces the number of laser sessions required. However, better materials are required.
Background and AimsMatrix metalloproteinase-9 [MMP9] is implicated in the pathogenesis of ulcerative colitis [UC] via disruption of intestinal barrier integrity and function. A phase 2/3 combined trial was designed to examine the efficacy, safety, and pharmacokinetics of the anti-MMP9 antibody, andecaliximab [formerly GS-5745], in patients with moderately to severely active UC.MethodsPatients were randomised [1:1:1] to receive placebo, 150 mg andecaliximab every 2 weeks [Q2W], or 150 mg andecaliximab weekly [QW], via subcutaneous administration. The primary endpoint was endoscopy/bleeding/stool [EBS]-defined clinical remission [endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and at least a 1-point decrease from baseline in stool frequency to achieve a subscore of 0 or 1] at Week 8. The phase 2/3 trial met prespecified futility criteria and was terminated before completion. This study describes results from the 8-week induction phase.ResultsNeither 150 mg andecaliximab Q2W or QW resulted in a significant increase vs placebo in the proportion of patients achieving EBS clinical remission at Week 8. Remission rates [95% confidence intervals] were 7.3% [2.0%–17.6%], 7.4% [2.1%–17.9%], and 1.8% [0.0%–9.6%] in the placebo, andecaliximab Q2W, and andecaliximab QW groups, respectively. Similarly, Mayo Clinic Score response, endoscopic response, and mucosal [histological] healing did not differ among groups. Rates of adverse events were comparable among andecaliximab and placebo.ConclusionsEight weeks of induction treatment with 150 mg andecaliximab in patients with UC did not induce clinical remission or response. Andecaliximab was well tolerated and pharmacokinetic properties were consistent with those previously reported.
Background
Esophagogastroduodenoscopy (EGD) is commonly used diagnostic method with no widely accepted quality measure. We assessed quality indicator—composite detection rate (CDR)—consisting of detection of at least one of the following: cervical inlet patch, gastric polyp and post-ulcer duodenal bulb deformation. The aim of the study was to validate CDR according to detection rate of upper gastrointestinal neoplasms (UGN).
Methods
It was a multicenter, prospective, observational study conducted from January 2019 to October 2019. The endoscopic reports from 2896 symptomatic patients who underwent diagnostic EGD were analyzed. The EGDs were performed in three endoscopy units located in tertiary university hospital, private outpatient clinic and local hospital.
Results
64 UGNs were detected. The mean CDR was 21.9%. The CDR correlated with UGN detection rate (R = 0.49, p = 0.045). Based on CDR quartiles, operators were divided into group 1 with CDR < 10%, group 2 with CDR 10–17%, group 3 with CDR 17.1–26%, and group 4 with CDR > 26%. Detection rate of UGN was significantly higher in the group 4 in comparison to group 1 (OR 4.4; 95% CI 2.2 − 9.0). In the multivariate regression model, patient age, male gender and operator’s CDR > 26% were independent risk factors of UGN detection (OR 1.03; 95% CI 1.01 − 1.05, OR 2; 95% CI 1.2 − 3.5, and OR 5.7 95% CI 1.5 − 22.3, respectively).
Conclusions
The CDR is associated with the detection of upper gastrointestinal neoplasms. This parameter may be a useful quality measure of EGD to be applied in general setting.
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