Introduction

By definition, indeterminate biliary strictures are those that cannot be diagnosed with routine imaging modalities, including ultrasound, CT scan, and MRI. In such cases, single-operator cholangioscopy (SOC) has emerged as a useful tool for diagnostic and therapeutic interventions, which enables visualization of the bile duct and allows for targeted biopsies of suspicious lesions. The use of SOC has been shown to improve diagnostic accuracy, decrease the need for additional procedures, and guide therapeutic interventions. Nevertheless, pooled sensitivity for diagnosis of SOC-guided biopsies in the diagnosis of malignant biliary strictures is limited with approximately 60%. So far, there is no evidence on which biopsy technique is best and how many biopsy samples need to be taken to improve diagnostic accuracy.

Aims & Methods

Aim: To evaluate the best sampling technique comparing two versions of the SpyBite forceps to optimize diagnostic yield for the differentiation of indeterminate biliary stricture.
Patients and methods: Patients with an indeterminate biliary stricture with an independent indication to perform an ERCP with SOC and bile duct sampling were recruited to participate in this prospective, randomized, multicenter study. Patients were equally randomized into the following study arms: (i) single biopsy (SB); (ii) multiple biopsies with suction technique (MB); (iii) bite-on-bite biopsies (BB). At least 6 biopsies had to be obtained in each group. Furthermore, the best sampling technique was transferred into phase 2 of the study comparing conventional forceps (Spybite) vs. larger forceps (Spybite max.). Final diagnosis was defined as prove of malignancy, histology of surgical resectate or 6 months follow-up without signs of malignancy. Adequacy of the samples was rated according to a 6 point rating scale (cytological samples rate 0-2; histological samples rates 3-5). Sensitivity/specificity of samples were defined as primary endpoint.

Results

A total of 60 patients (20pt. per group, mean age 67y, 48% female) were included in the first study phase. In the SB, MB and BB group a mean of 6.4, 6.7 and 6.5 samples was taken, respectively. Of note, in the MB group a significant difference of the number of samples being evaluated (∆=3.5; -47.8%) was observed indicating a loss of samples during suction. Resulting sensitivity/specificity of the obtained samples was: SB 76/89%; MB 61/85%; BB 79/92%, with a significant lower level in the MB group compared to SB and BB (p=0.01). In the 2^nd study phase 20 patients were included per group. Usage of the larger forceps significantly increased sensitivity to 85% (p=0.01) with a specificity of 95% applying the BB technique. Conventional forceps obtained cytological samples in 48.3% and histological samples in 51.7%, whereas larger forceps resulted in 8.3% cytological samples (p=0.0001) and histological samples in 91.7% (p=0.001).

Conclusion

Based on the results of this study, the bite-on-bite biopsy technique using larger forceps (Spybite max.) appears to be the best sampling technique for optimizing diagnostic yield in the differentiation of indeterminate biliary stricture.

Disclosure

Mark Ellrichmann, Arne Kandulski, Markus Dollhopf, Arno Dormann, Alexander Dechene, Torsten Beyna, Christian Gerges received lectures fees from Boston Scientific

Introduction

Chronic constipation (CC) is one of the most frequent non-motor features of Parkinson’s Disease (PD). Previous studies highlighted the association of CC with PD duration and severity [1]. Furthermore, gut microbiota changes and brain-gut-axis (BGA) dysregulation are common in PD and these alterations are related with clinical manifestations [2,3]. For this reason, probiotics, balancing the gut microbiota, are emerging as a potential therapeutic approach in PD patients.

Aims & Methods

Objective: To evaluate the patients’ satisfaction rates as well as gastroenterological and neurological effects of the administration of a synbiotic in PD patients with CC.
Methods: This study enrolled patients with stable PD who fulfilled Rome IV Criteria for CC or irritable bowel syndrome with constipation (IBS-C). Patients received a synbiotic treatment (Enterolactis ® duo, 4 sachets/day, containing probiotic Lactobacillus casei and prebiotic inulin) for 12 weeks. Two primary endpoints were chosen to monitor the satisfaction with therapy (SWT). SWT was defined when patients were satisfied (satisfaction score >4 on a 7-point Likert scale) or improved after therapy (increase in the global rating of change scale of at least two points on a -7 to +7 visual analogue scale). In addition, a gastrointestinal (GI) evaluation with the Patient Assessment of Constipation-symptoms questionnaire (PAC-SYM), number of complete bowel movements per week, Bristol stool Scale (BSS) were calculated before and after the treatment. The neuropsychological evaluation was performed by the Montreal Cognitive Assessment (MoCA), Movement Disorder Society-Sponsored Revision of Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), SCales for Outcomes in Parkinson’s disease - Autonomic Dysfunction (SCOPA-AUT), Toronto Alexithymia Scale (TAS-20), Reading the Mind in the Eyes Test (RMET), Parkinson Anxiety Scale (PAS), State-Trait Anxiety Inventory (STAI-Y), Beck Depression Inventory (BDI II), Hamilton depression rating scale (HAM-D) pre- and post-intervention.

Results

30 patients (10 F) were consecutively enrolled. Satisfaction >4 (endpoint 1) significantly changed from 17% to 60% patients after treatment, p = 0.002. The calculated satisfaction score significantly increased from 4(1) to 5(2) (median (IQR), p = 0.003. Improvement after treatment (endpoint 2) was achieved by 83% of patients. The Global Rating of Change Score changed significantly from 0(3) to 4(2)(median (IQR), p < 0.001. Moreover, a beneficial effect of treatment was shown on GI symptoms. Specifically, PAC-SYM Questionnaire score changed from 1.42(0.94) to 0.91(0.77), p < 0.001, number of complete bowel movements per week from 3(3.5) to 5.5(4.1) p < 0.001 and Bristol stool Scale (BSS) from 2(2) to 3(2) p < 0.001. After treatment PD patients performed better in motor and non-motor features. Specifically, the scores (median (IQR) of TAS-20 significantly changed from 55.0 (22) to 49.5 (21), p=0.03, SCOPA-AUT from 17.0 (7) to 13.5 (10), p = 0.002, MDS-UPDRS part 1 from 13.5 (13) to 9.0 (6), p = 0.001, HAM-D score from 12.5(10) to 9.0 (12), p = 0.045. PAS-A showed a trend towards significance from 7.0(6) to 5.0(7), p = 0.06.

Conclusion

Our results showed that a considerable number of PD patients with CC or IBS-C were satisfied with their defecation after treatment. GI symptoms as well as motor and non-motor features in PD patients improved. Our data suggest that the addition of a synbiotic Enterolactis ® duo may be a useful therapeutic approach in PD possibly acting on the gut-brain-gut axis.

References

References
[1] Krogh K, Ostergaard K, Sabroe S, Laurberg S. Clinical aspects of bowel symptoms in Parkinson’s disease. Acta Neurol Scand. 2008;117(1):60-64.
[2] Shen T, Yue Y, He T, Huang C, Qu B, Lv W, Lai HY. The Association Between the Gut Microbiota and Parkinson’s Disease, a Meta-Analysis. Front Aging Neurosci. 2021 Feb 12;13:636545.
[3] Scheperjans F, Aho V, Pereira PA, et al. Gut microbiota are related to Parkinson’s disease and clinical phenotype. Mov Disord. 2015;30(3):350-358.

Introduction

Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The recommended induction scheme is 10 mg twice daily (BID) for at least 8 weeks followed by a maintenance dose of 5 mg BID. However, some patients require 10mg bid, for 16 weeks at the induction phase. Our study aimed to assess the demographics and disease characteristics of such patients and their outcome at 24 weeks.

Aims & Methods

This was a multicenter, retrospective, observational study which included patients with moderate to severe UC, who received induction therapy with Tofacitinib 10mg bid for a 16-week period. Data were collected between July 2018 and November 2022. The primary objective was disease outcome, defined as clinical remission and/or the need of steroids. Secondary outcomes were treatment withdrawal, treatment de-escalation and adverse events.

Results

In total 31 patients, are currently enrolled in our study, from 10 IBD centres [males: 51.6%, mean age at study entry: 40.0 years, median disease duration: 7 years]. Patient demographic and clinical characteristics at baseline are shown in table 1. Four patients (12.9%) discontinued treatment before week 24, due to inadequate response. De-escalation of dosing to 5mg bid tofacitinib was attempted in 13 of 27 patients (48.1%) and was successful in 7 patients (53.8%) who maintained clinical response until week 24 of the study. Of the other 6 out of 13 patients, 6 patients received again the higher dose (10 mg bid) and regained response and only one patient discontinued treatment. Overall, 85.7% (6/7) of the patients who received tofacitinib 5mg bid and 66.7% (14/21) who received 10mg bid at 24 weeks, had received more than one biologic prior to tofacitinib (P=0.34). At week 24, the partial Mayo score was available in 26 patients; 13 patients were in steroid-free clinical remission (pMayo <2). Twelve patients had mild active disease (pMayo 2-4) and 9 of them had stopped steroids. No major adverse events were observed during the entire observation period.

Conclusion

In a real-world setting, a 24-week treatment with tofacitinib 10mg BID is safe and the majority of patients achieve clinical remission and manage to stop steroids. De-escalation at 5mg bid is successful in more than half of them. We prospectively follow up our cohort to investigate whether these preliminary results will be confirmed for a longer period.

Introduction

Non-variceal upper gastrointestinal bleeding (NVUGIB) is a common gastroenterological emergency associated with significant morbidity and mortality [1-3]. Upper gastrointestinal endoscopy is currently recommended as the gold standard modality for both diagnosis and treatment [4]. As historically played a limited role in the diagnosis of acute NVUGIB, multidetector-row computed tomography angiography (MDCTA) is emerging as a promising tool in the diagnosis of NVUGIB, especially for severe cases [5-6]. However, to date, evidence concerning the role of MDCTA in the NVUGIB diagnosis is still lacking.

Aims & Methods

The purpose of this study was to retrospectively investigate the diagnostic performance of emergent MDCTA performed prior to any diagnostic modality or following urgent upper endoscopy to identify the status, the site and the underlying etiology of severe NVUGIB. Institutional databases were reviewed in order to identify severe acute NVUGIB patients who were admitted to our bleeding unit and were referred for emergent MDCTA prior to any hemostatic treatment (<3 hours) or following (<3 hours) endoscopy, between December 2019 and October 2022. The study aim was to evaluate the diagnostic performance of MDCTA to detect the status, the site and the etiology of severe NVUGIB with endoscopy, digital subtraction angiography, surgery, pathology or a combination of them as reference standards.

Results

A total of 68 patients (38 men, median age 69 years [range 25–96]) were enrolled. The overall MDCTA sensitivity, specificity, and accuracy to diagnose bleeding status were 77.8% (95% CI: 65.5-87.3), 40% (95% CI: 5.3-85.3), and 75% (95% CI: 63.0-84.7), respectively (Table 1). Finally, the overall MDCTA sensitivity to identify the bleeding site and the bleeding etiology were 92.4% (95% CI: 83.2-97.5) and 79% (95% CI: 66.8-88.3), respectively.

Table 1. The diagnostic performance of MDCTA in detecting bleeding status.

Conclusion

MDCTA seems to be a feasible and effective modality in detecting the site, the status and the etiology of severe acute NVUGIB. It may play a crucial role in the management of selected cases of NVUGIB, especially those clinically severe and/or secondary to rare and extraordinary rare sources, effectively guiding timing and type of treatment. However, further large prospective studies are needed to clarify the role of MDCTA in the diagnostic process of acute NVUGIB.

References

1. Wuerth BA, Rockey DC. Changing Epidemiology of Upper Gastrointestinal Hemorrhage in the Last Decade: A Nationwide Analysis. Dig Dis Sci 2018; 63: 1286–1293.
2. Laine L, Yang H, Chang S-C, et al. Trends for incidence of hospitalization and death due to GI complications in the United States from 2001 to 2009. Am J Gastroenterol 2012; 107: 1190–1195; quiz 1196.
3. Sanders DS, Perry MJ, Jones SGW, et al. Effectiveness of an upper-gastrointestinal haemorrhage unit: a prospective analysis of 900 consecutive cases using the Rockall score as a method of risk standardisation. Eur J Gastroenterol Hepatol 2004; 16: 487–494.
4. Gralnek IM, Stanley AJ, Morris AJ, et al. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy 2021; 53: 300–332.
5. Napoli A, Fleischmann D, Chan FP, et al. Computed tomography angiography: state-of-the-art imaging using multidetector-row technology. J Comput Assist Tomogr 2004; 28 Suppl 1: S32-45.
6. Wu L-M, Xu J-R, Yin Y, et al. Usefulness of CT angiography in diagnosing acute gastrointestinal bleeding: a meta-analysis. World J Gastroenterol 2010; 16: 3957–3963.

Disclosure

No conflict of interest to declare.