Introduction

Different random biopsy techniques exist for Barrett Esophagus (BE) surveillance, of which the impact on histopathological quality is unclear. Therefore, we compared the double-biopsy (DB) versus single-biopsy (SB) method, and advance-and-close (A&C) versus turn-and-suction (T&S) technique in a multidesign study.

Aims & Methods

In a multicenter, factorial design trial, BE patients were randomly assigned to one of two biopsy methods (DB or SB) and techniques (A&C or T&S) in a 1:1:1:1 approach, stratified by BE length and hospital. Endpoints were biopsy size, defined as surface area in mm², and time required to obtain biopsies. Assessment of biopsy size was done in a blinded fashion. Data was analyzed with mixed effects regression analyses with a random intercept per patient including stratification factors as fixed effects. We assumed no interaction between the co-primary comparisons.
In a subsequent before-after study, the optimal biopsy method and technique found in the factorial trial was implemented in routine clinical practice. Biopsies before and after implementation were analyzed on biopsy size, using mixed effects regression analyses with a random intercept per patient including BE length as fixed effect.

Results

Table 1: Biopsy size in mm2 per biopsy method and technique (95% CI).	Double-biopsy (DB)	Single-biopsy (SB)
Advance-and-close (A&C)	2.77 (2.44-3.09)	3.14 (2.81-3.46)
Turn-and-suction (T&S)	2.61 (2.29-2.93)	3.54 (3.22-3.86)

In the factorial trial, 107 patients were randomized and 1024 biopsies were assessed. Mean biopsy size for each randomization arm, that is, DB+A&C, DB+T&S, SB+A&C, SB+T&C was 2.77mm² (95%CI 2.44-3.09), 2.61 mm² (95%CI 2.29-2.93), 3.14 mm² (95%CI 2.81-3.46) and 3.54 mm² (95%CI 3.22-3.86), respectively (Table 1). Biopsy size increased with 25% from 2.68mm² (95%CI 2.45-2.92) with the DB method to 3.34mm² (95%CI 3.10-3.57) with the SB method (mean difference 0.65mm², [95% CI 0.34-0.97]; p<0.001). In contrast, average biopsy sizes were 2.95mm² (95% CI 2.72-3.19) and 3.08mm² (95%CI 2.85-3.31) using the A&C and T&S, respectively, translating into an increase of 4% using the T&S technique (mean difference 0.13mm², [95%CI -0.19-0.44]; p=0.44). The interaction term between the co-primary comparisons was not statistically significant (p=0.08).
Time required to obtain biopsies was comparable for biopsies obtained with the DB method and SB method (mean difference 2 seconds per biopsy, [95%CI -1-4]; p=0.26), while biopsy time was significantly longer when biopsies were taken with the T&S technique compared to the A&C technique (mean difference 7 seconds per biopsy, [95%CI 4-10]; p<0.001).
A total of 46 patients (288 biopsies) and 44 patients (256 biopsies) were included before and after implementation of the SB method and the T&S technique, respectively. Before implementation, 93/288 biopsies (32%) were obtained with the A&C technique and 163/288 biopsies (57%) were taken with the DB method. Mean biopsy size increased with 18% from 3.31mm² (95%CI 2.95-3.68) to 3.90mm² (95%CI 3.50-4.29) after implementation of the SB method and T&S technique (mean difference 0.58mm² (95%CI 0.07-1.09); p=0.03). Mean biopsy size did not significantly increase when comparing biopsies before and after implementation (n=117 versus n=97) which were obtained by endoscopists already using the SB method and T&S technique before implementation (3.72mm² [95%CI 2.95-4.48] versus 3.79mm² [95%CI 2.97-4.62], mean difference 0.08mm² [95%CI -0.93-1.08]; p=0.88).

Conclusion

Biopsies in BE patients should be taken with the SB method to increase biopsy size. Implementation of SB-T&S in routine clinical practice resulted in significantly larger biopsies.

Disclosure

B.L.A.M. Weusten is a consultant for Pentax Medical, has received speaker’s fee from Pentax Medical and has received research funding from Aqua Medical and Pentax Medical. The remaining authors declare that there is no conflict of interest.

Introduction

The burden of Hepatitis C Virus (HCV) remains a critical public health issue, particularly among People Who Inject Drugs (PWID), who represent a high-risk and often underserved population. Psychiatric care settings—where PWID often seek support for mental health and substance use disorders are key points for opportunistic HCV screening and linkage to care.

Results & Findings

We analyzed two periods: before (2021-2022) and after (2023-2024) integrated hepatology-psychiatry care in the context of HCV treatment. During the whole 4 year period we treated 125 HCV patients, more (n=98) after integrated hepatology-psychiatry care compared to the period before (n=27), p<0.05. Overall, 55.2% (n=69) of patients were PWIDs, predominantly in the period after (92.7%) compared to the period before (7.3%; p<0.05). Majority of treated patients (84%) received their first DAA treatment, 3.3% were retreated due to previous treatment failure, while the rest were retreated due to reinfection.
Of 125 patients, 93% (n=117) were tested and all achieved end of treatment (EOT) response. Among them 63 were PWIDs. Of six PWIDs who were not EOT tested, 5 were lost to follow-up and 1 patient died. In the follow up, 100 patients were tested for sustained viral response (SVR) and 97% achieved SVR. Out of 17 who were not SVR tested, 6 still have not reached SVR period and 11 patients did not show up (90% of them were PWIDs).

Summary & Discussion

Our data indicate that integrated hepatology-psychiatry collaborations can increase treatment in PWID populations. An integrated model of care should help in reducing loss to follow-up in this difficult to treat population.

Conclusion

This practice underscore the importance of cross-specialty nursing cooperation in bridging healthcare gaps and support the development of access models that address both medical and psychosocial needs in vulnerable groups.

References

Dale CH, Smith E, Biondi MJ. Nurse practitioners as primary care site champions for the screening and treatment of hepatitis C virus. J Am Assoc Nurse Pract. 2022 Jan 21;34(4):688-695. doi: 10.1097/JXX.0000000000000689.
Clark CH, Ghalib RH. Hepatitis C: role of the advanced practice nurse. AACNClin Issues. 1999 Nov;10(4):455-63. doi: 10.1097/00044067-199911000-00005.

Disclosure

Nothing to disclose.

Introduction

Crohn's disease is characterized by patchy, transmural inflammation predominantly affecting the ileum and colon. Ileo-colonoscopy remains the gold standard for assessing mucosal inflammatory activity in clinical trials, and can be quantified using the Simple Endoscopic Score for Crohn’s Disease (SES-CD). However, ileo-colonoscopy is invasive, therefore there has been growing interest in non-invasive imaging modalities such as magnetic resonance imaging (MRI). The Simplified Magnetic Resonance Index of Activity (sMaRIA) is an MRI-based score which provides a standardised approach for evaluating disease activity. Most previous studies investigating the correlation between sMaRIA and SES-CD have been single centre studies with limited numbers of readers and performed only in patients with longstanding disease. While MRI is superior to colonoscopy for assessment of transmural penetrating and stricturing disease, the performance of sMaRIA for assessment of mucosal activity in the post-treatment setting remains unanswered.

Aims & Methods

To evaluate the performance of sMaRIA for detection of mucosal inflammation in patients with recently diagnosed Crohn’s disease using ileo-colonoscopy and SES-CD as the reference standard. We conducted a post-hoc analysis of the PROFILE trial, in which patients had undergone paired ileo-colonoscopy and small bowel MRI at end of trial (week 48). Central reading was performed by validated pools of consultant radiologists (MRI) and gastroenterologists (ileo-colonoscopy), blinded to clinical data. Correlations between SES-CD and sMaRIA scores were assessed, alongside classification performance and remission rates by treatment arm. For this study endoscopic and MRI remission were respectively defined as SES-CD ulcer subscore <1 and sMaRIA ulcer subscore of 0.

Results

253 patients had paired ileo-colonoscopy and MRI at end of trial with a median time gap of 22 days between investigations and no treatment change over this period. The overall correlation between SES-CD and sMaRIA scores at week 48 was poor (Spearman’s rank=0.196). [KS(UHNFT1] Overall sMaRIA had low sensitivity (27%) [NN2] for identifying active inflammation evident on ileo-colonoscopy. On segmental analysis MRI detected only 4/146 ulcerated segments (SES-CD ulcer subscore >0). Focusing on patients with ileal involvement, terminal ileal ulcer subscores also showed low correlation (Spearman’s rank=0.11). When using the mucosal component of MRI / sMaRIA to assess ulcer-free remission, no difference in end of trial outcomes was observed for “top-down” vs “accelerated step-up” treatment groups (95% vs 96% remission, p=0.728). Rates of ulcer-free remission assessed by SES-CD were different between treatment groups (86% vs 71% remission, p=0.004).

Conclusion

In this cohort of recently-diagnosed patients with Crohn’s disease and predominantly inflammatory disease phenotype, sMaRIA showed low sensitivity for detecting mucosal inflammation / ulceration. Had sMaRIA been used instead of SES-CD in the PROFILE trial it would have failed to identify the benefit of the “top-down” treatment strategy. These findings suggest that sMaRIA on MRI should not replace SES-CD scoring on ileo-colonoscopy for assessing mucosal inflammatory activity in Crohn’s disease.

References

A biomarker-stratified comparison of top-down versus accelerated step-up treatment strategies for patients with newly diagnosed Crohn's disease (PROFILE): a multicentre, open-label randomised controlled trialNoor, Nurulamin MNoor, Nurulamin et al.
The Lancet Gastroenterology & Hepatology, Volume 9, Issue 5, 415 - 427