Safety, Efficacy and Persistence of Advanced Therapies in Inflammatory Bowel Disease: Results from ORIGINS. A Retrospective Observational Study.

BACKGROUND AND AIMS: Real-world assessments of efficacy and safety of advanced therapies used for inflammatory bowel disease (IBD) patients are limited. We aimed to report safety, efficacy and treatment persistence of new molecules (infliximab, adalimumab, vedolizumab, tofacitinib, ustekinumab) in a retrospective multicentric national Romanian analysis. METHODS: We conducted a nationwide, retrospective observational multicentric study. Data were collected retrospectively from electronic and paper files. Patients who started on one of the five investigated molecules during December 2019-December 2021 were included. The main outcome measures were clinical remission, endoscopic healing, persistence on treatment and safety data. RESULTS: A total of 678 adult patients from 24 Romanian IBD centers with a diagnosis of ulcerative colitis or Crohn's disease were included. Participants had previously failure to one (268, 39.5%), two (108, 15%) or more treatment lines and only 38% (259) were biologic naïve. In the 24 months study period, most patients were started on vedolizumab (192, 28%), followed by adalimumab, infliximab, ustekinumab and tofacitinib. In biologic-naïve patients, most physicians (72%) preferred anti-TNF treatment as first line biologic (93 patients started on infliximab, 92 on adalimumab), followed by vedolizumab, ustekinumab and tofacitinib. During follow-up, 71% (470, p=0.05) of patients achieved clinical remission and 36% (134, p=0.03) achieved mucosal healing. The 6 months milestone for persistence was reached in 78% (530) of cases. Almost half of patients (47%, 316 patients) persisted on their current treatment for over 12 months. Overall, an adverse reaction was reported for 67 (10.4%) patients, with no lethal events. CONCLUSIONS: Population of biologic-experienced IBD patients in Romania is increasing and is becoming more difficult to achieve long-term disease control. Discontinuation rates for advanced therapies are high.

A simple clinical score to stratify the risk of procedure-related adverse events in ERCP procedures with trainee involvement.

BACKGROUND : Optimal training strategies in endoscopic retrograde cholangiopancreatography (ERCP) remain controversial despite the shift toward competence-based training models, with limited data available on patient safety during training. We aimed to assess whether pre-procedural clinical predictors could identify patients at low risk of developing procedure-related adverse-events (AEs) in a training environment. METHODS : We performed a prospective, multicenter, cohort study in five training centers. A data collection system documenting indication, clinical data, trainee performance (assessed using a validated competence assessment tool), technical outcomes, and AEs over a 30-day follow-up was utilized. We developed a clinical risk score (Trainee Involvement in ERCP Risk Score [TIERS]) for patients undergoing ERCP and compared the rate of AEs in a training environment between low-risk and high-risk groups. The association between trainee performance and AE rate was also evaluated. RESULTS : 1283 ERCPs (409 [31.9 %, 95 %CI 29.3 %-34.4 %] with trainee involvement) performed by 11 trainers and 10 trainees were analyzed. AEs were more frequent in the high-risk compared with the low-risk group: 26.7 % (95 %CI 20.5 %-34.7 %) vs. 17.1 % (95 %CI 12.8 %-22.2 %). TIERS demonstrated a high negative predictive value for AEs (82.9 %, 95 %CI 79.4 %-85.8 %) and was the only predictor of AEs on multivariable analysis (odds ratio 1.38, 95 %CI 1.09-1.75). Suboptimal trainee performance was associated with an increase in AE rates. CONCLUSION : Simple, clinical-based predictive tools could improve ERCP training by selecting the most appropriate cases for hands-on training, with the aim of increasing patient safety.

Achalasia at the Crossroads Between Specialties.

Background: Achalasia is a condition that can be treated either by surgery, such as Heller myotomy associated with an antireflux procedure, or by pneumatic dilation, the choice of type of treatment being a widely debated topic nowadays. Methods: We selected patients with the diagnosis of achalasia, calculating the Eckardt score on admission and they were treated by pneumatic dilation, respectively by myotomy associated with fundoplication. Therapeutic success at the end of treatment was analyzed, as well as that in subsequent follow-ups. At the same time, other important aspects of the study were quality of life and complications. Results: Forty-eight patients were included, 20 in the group of those treated by pneumatic dilation, and 28 treated by surgery. The results of the therapeutic success were to the advantage of the surgery, both after the completion of the treatment, and in the follow-ups from one year to 2 years (96.4% vs 90%, respectively 92.9% vs. 85%). The quality of life was better in patients with pneumatic dilation throughout the period. Conclusions: Surgical treatment of achalasia has a higher success rate than pneumatic dilation, but the latter is associated with a better quality of life.

Unmet needs in the diagnosis and treatment of Romanian patients with bilio-pancreatic tumors: results of a prospective observational multicentric study.

Background. Biliopancreatic tumors (BPT) are among the most aggressive solid malignancies, and their incidence is rising. Good patient outcome relies heavily on a multidisciplinary approach to therapy, including timely access to endoscopy, surgery and chemo/radiotherapy. We aimed to evaluate current practices as reflected in the management and outcome of patients diagnosed with BPT in the setting of a low-resource medical system in order to identify areas suitable for improvement. Material and methods. We conducted a prospective observational study of patients with pancreatic cancers and extrahepatic cholangiocarcinomas evaluated in 4 referral centers in Romania. We collected data on the pathology of the tumors, staging at diagnosis, ECOG status, surgical interventions, chemo/radiotherapy and endoscopic drainage where applicable. A telephonic follow-up visit at 3 months after the enrollment visit collected additional data regarding evolution, subsequent treatment, performance status and disease-related events and outcomes. Results and conclusions. One hundred seventy-two patients were included in the study during a one-year period at the four participating centers. 72.1% were diagnosed with pancreatic cancer while 27.9% had extrahepatic cholangiocarcinoma. We identified several unmet needs in the current practices of treatment for these malignancies: a lack of pathological confirmation in 25.6% of the cases, a very low percentage of resectable lesions (only 18% of the patients operated with curative intent), and suboptimal choice of drainage in patients who required palliative drainage at their first endoscopic intervention. Significant effort is required to ensure standard-of-care treatment for patient with BPT in low-resource medical systems, including comprehensive auditing and protocol surveillance.

Impact of trainee involvement on the outcome of ERCP procedures: results of a prospective multicenter observational trial.

BACKGROUND: Training in advanced endoscopic techniques such as endoscopic retrograde cholangiopancreatography (ERCP) should be driven by key performance measures and standardized competence assessment in order to provide safe and high-quality interventions. We aimed to determine whether the involvement of trainees influences the outcome of the procedure and the incidence of ERCP-related adverse events. METHODS: This was an international, multicenter, prospective, observational study conducted at six high- and low-volume centers across Europe between October 2016 and October 2018, and included independent operators and their trainees. Standard report forms documenting indication, trainee involvement, technical outcome, and complications over a 30-day follow-up of consecutive ERCP procedures were included in the analysis. Technical success of the procedure and procedure-related adverse events were compared between procedures in the trainee group and the control group using bivariable and multivariable analysis. RESULTS: 21 trainees and 16 control endoscopists performed 1843 ERCPs during the study period. Trainee involvement in ERCP procedures did not decrease technical success (92.4 % vs. 93.7 %; P = 0.30) or increase the risk of adverse events (14.7 % vs. 14.6 %; P > 0.99). Conversely, there were significantly more moderate or severe adverse events in the control group compared with the trainee group (6.2 % vs. 3.4 %, P = 0.01). On multivariable analysis, only increased bilirubin levels, time to cannulation, and procedure difficulty level increased the risk of any procedure-related adverse event. CONCLUSION: Trainee involvement in ERCP interventions within a proper teaching setting is safe and does not compromise the success of the procedure.

Usefulness of virtual chromoendoscopy in the evaluation of subtle small bowel ulcerative lesions by endoscopists with no experience in videocapsule.

BACKGROUND AND STUDY AIMS: In videocapsule endoscopy examination (VCE), subtle variations in mucosal hue or pattern such as those seen in ulcerations can be difficult to detect, depending on the experience of the reader. Our aim was to test whether virtual chromoendoscopy (VC) techniques, designed to enhance the contrast between the lesion and the normal mucosa, could improve the characterization of ulcerative mucosal lesions. PATIENTS AND METHODS: Fifteen trainees or young gastroenterologists with no experience in VCE were randomly assigned to evaluate 250 true ulcerative and 100 false ulcerative, difficult-to-interpret small bowel lesions, initially as white light images (WLI) and then, in a second round, with the addition of one VC setting or again as WLI, labeling them as real lesions or artifacts. RESULTS: On the overall image evaluation, an improvement in lesion characterization was observed by adding any chromoendoscopy setting, especially Blue mode and FICE 1, with increases in accuracy of 13 % [95 %CI 0.8, 25.3] and 7.1 % [95 %CI - 17.0, 31.3], respectively. However, when only false ulcerative images were considered, with the same presets (Blue mode and FICE 1), there was a loss in accuracy of 10.7 % [95 %CI - 10.9, 32.3] and 7.3 % [95 %CI - 1.3, 16.0], respectively. The interobserver agreement was poor for both readings. CONCLUSIONS: VC helps beginner VCE readers correctly categorize difficult-to-interpret small bowel mucosal ulcerative lesions. However, false lesions tend to be misinterpreted as true ulcerative with the same presets. Therefore care is advised in using VC especially under poor bowel preparation.