Introduction

The detection and resection of adenomatous polyps during colonoscopy has been shown to be the most effective way to decrease the incidence of colorectal cancer and associated mortality ^{1, 2}, with adenoma detection rate (ADR) being a key quality performance indicator. While higher ADR is associated with lower post-colonoscopy colorectal cancer (PCCRC) rates, the latter varies significantly across the UKand the true ‘baseline’ ADR is unknown ^3,4. Meeting the rising demand for high quality colonoscopy is a significant challenge.
The use of computer assisted detection (CADe) is associated with a significant improvement in ADR across multiple clinical trials^{5, 6}, but real-world performance data is lacking.
We sought to evaluate effect on adenoma detection of implementing CADe in a ‘real-world’ setting, in the largest such study to date.

Aims & Methods

This was a randomised, stepped-wedge, open-label trial, using the GI Genius™ (GIG) module, powered to measure the site effect of CADe. A mix of District General Hospitals (DGH) and Teaching Hospitals (TH) were included, with an emphasis on ‘non-expert’ colonoscopists (lifetime colonoscopy <2000 at study start). ‘Expert’ colonoscopists were eligible (lifetime colonoscopy >2000 and ADR>40%).
Data collection was divided into three, 3-month phases: phase 1, baseline data collection with no CADe; phase 2, the intervention phase, where GIG-CADe was active; phase 3 where GIG-CADe was removed. The endoscopists and procedural information were recorded during the three phases. ADR across all three phases was analysed and compared.
Data will be forthcoming from 29 hospitals (England, Scotland, and Wales), n=124 colonoscopists and n>5000 patients, but we report herein results from the first 8 sites to complete the trial.
All patients undergoing routine (non-BCSP) colonoscopy were eligible, but those having colonoscopy for polyp or IBD surveillance were excluded. The study design was as close to real world practice as possible, with no other changes in procedure or technique.

Results

Across the 8 sites involved (2 TH), there were 34 endoscopists (64.7% non-expert vs 35.3% expert) and 1418 patients (56.43±16.9 years; 49.5% female) eligible for analysis. Comparative results (univariate analysis) through the three study phases are reported in table 1. When adjusted for bowel preparation and the endoscopists’ experience, there was a 9.53% increase in ADR in the CADe group (r² = 0.159; p = 0.0142).
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Conclusion

NAIAD is the largest trial of CADe to date and, in this interim analysis, establishes a baseline UK ADR of approximately 27.0%. The use of GIG-CADe is associated with a significant increase in ADR, but this returns to baseline when the device is switched off. Further analysis of our result will inform the implementation of CADe in routine practice.

References

Reference:
1) M.F. Kaminski, J. Regula, E. Kraszewska, et al. Quality indicators for colonoscopy and the risk of interval cancer N Engl J Med, 362 (2010), pp. 1795-1803
2) M.F. Kaminski, P. Wieszczy, M. Rupinski, et al. Increased rate of adenoma detection associates with reduced risk of colorectal cancer and death Gastroenterology, 153 (2017), pp. 98-105
3) Burr NE, Derbyshire E, Taylor J, Whalley S, Subramanian V, Finan P J et al. Variation in post-colonoscopy colorectal cancer across colonoscopy providers in English National Health Service: population based cohort study BMJ 2019; 367: l6090 doi:10.1136/bmj.l6090
4) D.A. Corley, C.D. Jensen, A.R. Marks, et al. Adenoma detection rate and risk of colorectal cancer and death N Engl J Med, 370 (2014), pp. 1298-1306
5) Shaukat A, Lichtenstein DR, Somers SC, Chung DC, et al Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25. PMID: 35643173.
6) Wang, Pu, et al. "Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study." The lancet Gastroenterology & hepatology 5.4 (2020): 343-351.

Introduction

Self-expanding metal stents (SEMS) are recommended by guidelines to relieve biliary obstruction caused by malignant strictures in a palliative setting. There are three types of SEMS, uncovered (UC), semi-covered (SC), and fully covered (FC) indicating the degree to which they are covered by a plastic film. The main concerns regarding bile duct stents are their ability to provide adequate drainage, maintain long-term patency, and overall safety. The intention with the plastic covering is to prevent tumour ingrowth and occlusion of the stent. However, this also makes the stents more liable to dislodge spontaneously (1). There are conflicting reports on UC and SC stents regarding long-term patency; some studies have shown a higher frequency of dysfunction in UC stents while others have not (2, 3). Only a few studies have examined the use of FC stents(4). The aim of this study is to examine the differences in long-term patency of UC, SC, and FC SEMS in palliative patients with jaundice caused by malignant obstruction of the distal bile duct.

Aims & Methods

In this prospective randomized multicenter study patients were recruited between March 2020 and August 2024 at 13 centers in Sweden performing ERCPs. Patients with malignant extrahepatic strictures, where curative surgery was considered unlikely, were included. Patients were randomized in a 1:1:1 ratio to receive UC, SC, or FC SEMS and followed sequentially for 12 months. The primary outcome was stent failure defined as either the patient undergoing re-ERCP or other biliary drainage intervention or clinical and laboratory signs indicating stent dysfunction. Patients were censored at stent failure, death, time point of curative surgery or when the follow-up time ended. This study was registered at ClinicalTrials.gov (NCT06453590).

Results

A total of 450 patients who had reached their respective endpoints were included in this preliminary intention-to-treat analysis: 163 patients in the UC group, 151 in the FC group and 136 in the SC group. The majority (83%) of the patients had pancreatic cancer. After 12 months of follow-up, 50 patients (11%) were alive with a functioning stent, 151 patients (34%) had received palliative oncological treatment, and 18 patients (4%) had undergone surgery with curative intent. Stent failure occurred in 17% (95% CI: 11-23%) of the UC group, 13% (95% CI: 7-18%) of the FC group, and 7% (95% CI: 3-12%) of the SC group. The failure rate was lower in the SC group (HR 0.4; 95% CI: 0.2-0.8) compared to the UC group. There was a non-significant difference in failure rate in the FC group (HR 0.7; 95% CI: 0.4-1.3) relative to the UC group.

Conclusion

To our knowledge, this is the first prospective randomized trial comparing the long-term patency of the three different types of SEMS. The results suggest that semi-covered SEMS have the lowest rate of stent failure in patients with extrahepatic malignant obstruction and may therefore be the most appropriate choice of stent for palliative patients.

References

1. Kim HS, Lee DK, Kim HG, Park JJ, Park SH, Kim JH, et al. Features of malignant biliary obstruction affecting the patency of metallic stents: a multicenter study. Gastrointest Endosc. 2002;55(3):359-65.
2. Saleem A, Leggett CL, Murad MH, Baron TH. Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation of distal malignant bile duct obstruction. Gastrointest Endosc. 2011;74(2):321-7.e1-3.
3. Almadi MA, Barkun AN, Martel M. No benefit of covered vs uncovered self-expandable metal stents in patients with malignant distal biliary obstruction: a meta-analysis. Clin Gastroenterol Hepatol. 2013;11(1):27-37.e1.
4. Yamashita Y, Tachikawa A, Shimokawa T, Yamazaki H, Itonaga M, Sakai Y, et al. Covered versus uncovered metal stent for endoscopic drainage of a malignant distal biliary obstruction: Meta-analysis. Dig Endosc. 2022;34(5):938-51.

Disclosure

The study received partial funding from Boston Scientific Nordic AB

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement is the current standard for drainage of distal malignant biliary obstruction (MBO), but carries a significant risk of post-procedural pancreatitis.[1] EUS-guided choledochoduodenostomy (EUS-CDS) is increasingly used as a promising alternative, but comparative studies are still scarce.[2,3] While previous studies have mainly focused on stent patency, the current study aims to evaluate whether EUS-CDS is superior to ERCP in achieving a textbook outcome for the patients, indicating an optimal post-procedural course.

Aims & Methods

This single-center study included patients with distal MBO who underwent technically successful (1) EUS-CDS with a lumen apposing metal stent (LAMS) plus additional coaxial stent or (2) ERCP with fully covered self-expandable metal stent (FCSEMS) as part of the prospective SCORPION studies and SPHINX trial, respectively.[1,4] The primary endpoint was textbook outcome, defined as the absence of procedure- or stent-related adverse events (AEs), reinterventions, or hospital readmissions within 30 days of the procedure. Secondary endpoints included individual components of the primary outcome, mortality, time to initiation of treatment (e.g., systemic therapy or surgery), and textbook outcome at 90 days.

Results

A total of 144 patients were enrolled for EUS-CDS (n=49) or ERCP (n=95). Primary etiologies included pancreatic cancer (n=117, 81%) and distal cholangiocarcinoma (n=14, 10%). Coaxial stents used in the EUS-CDS group were FCSEMS (n=20) or double pigtail plastic stents (n=29). Textbook outcome was achieved in 44 patients (90%) in the EUS-CDS group and in 67 patients (71%) in the ERCP group at 30 days (RR 1.27, 95% CI 1.08-1.50). EUS-CDS led to fewer procedure- or stent-related AEs (RR 0.35, 95% CI 0.14-0.84) compared with ERCP, particularly post-procedure pancreatitis (0% vs. 23%). Other AEs, including perforation (2% vs. 0%), bleeding (0% vs. 0%), stent dysfunction with or without cholangitis (4% vs. 6%), and cholecystitis (4% vs. 3%) were similar between groups. Hospital readmission rate was lower in the EUS-CDS group (6% vs. 30%, RR 0.21, 95% CI 0.07-0.65), as was the length of hospital stay (mean 0.3 days [SD 1.3] vs. 1.8 days [SD 4.0], P=0.01). In-hospital mortality (8% vs. 5%), need for reinterventions (8% vs. 6%), and time to treatment initiation, either surgery or chemotherapy, did not differ (median 33 days [IQR 23-42] vs. 30 days [IQR 18-41]). At 90 days, textbook outcome was more often present in the EUS-CDS group when compared to ERCP however the difference was no longer significant (78% vs. 69%, RR 1.22, 95% CI 1.02-1.44).

Conclusion

EUS-CDS with LAMS and additional coaxial stent was superior to ERCP with FCSEMS in achieving textbook outcome at 30 days post-procedure. EUS-CDS resulted in less procedure- or stent-related AEs, particularly post-procedure pancreatitis, and consequently in fewer hospital readmissions and shorter hospital stay. Therefore, when expertise is available, EUS-CDS with coaxial stent placement could be considered as primary biliary drainage technique in patients with distal MBO.

References

1. Onnekink, A. M., Gorris, M., Bekkali, N. L., et al (2024). Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial. Gut, gutjnl-332695. https://doi.org/10.1136/gutjnl-2024-332695
2. Teoh, A. Y. B., Napoleon, B., Kunda, R et al (2023). EUS-Guided choledocho-duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction: a multicenter randomized controlled trial (DRA-MBO trial). Gastroenterology, 165(2), 473-482.e2. https://doi.org/10.1053/j.gastro.2023.04.016
3. Chen, Y., Sahai, A., Donatelli, G. et al (2023). Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology, 165(5), 1249-1261.e5. https://doi.org/10.1053/j.gastro.2023.07.024
4. Fritzsche, J. A., Fockens, P., Besselink, M. G. et al (2024). Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study. Gastrointestinal Endoscopy. https://doi.org/10.1016/j.gie.2024.10.012

Disclosure

Paul Fockens acted as a consultant for Cook Endoscopy and Olympus, outside the submitted work.
Roy L.J. van Wanrooij acted as a consultant for Boston Scientific. Jeanin E. van Hooft has received research support from Cook Medical and acted as lecturer for Cook Medical, Boston Scientific and Falk, and as consultant for Olympus. Rogier P. Voermans received a research grant and acted as consultant for Boston Scientific. All outside the submitted work. All other authors declare that they have no competing financial interests or personal relationships that could have appeared to influence the work reported in this abstract.

Introduction

Post-procedural pancreatitis (PPP) is the most common adverse event associated with endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent is emerging as a promising approach for managing malignant distal biliary obstruction (MDBO), offering the potential to lower the risk of PPP. We compared the outcomes of EUS-CDS with ERCP when used as the primary modality for biliary decompression.

Aims & Methods

This was a multicenter randomized controlled study, enrolling consecutive patients admitted for obstructive jaundice due to malignant distal biliary obstruction with dilated common bile duct (CBD>15mm). Patients were randomly allocated to receive EUS-CDS or ERCP for primary biliary drainage. This was a superiority trial with post-procedural acute pancreatitis (abdominal pain, elevation in pancreatic enzymes, and hospitalisation) as primary outcome. Other outcomes included technical success, clinical success, adverse events, 6-months stent patency rate, and overall survival. Analyses were performed according to intention-totreat principles.

Results

Between April 2021 and October 2023, 220 patients were enrolled in the study (EUS-CDS group: 111; ERCP group: 109). EUS-CDS group showed a lower risk for post-procedural acute pancreatitis (1.8% in EUS-CDS group vs 7.3% in ERCP group; RR: 0.25, 95%CI 0.07-0.88). Technical success was achieved in 94.6% in EUS-CDS group vs 78.9% ERCP group (p value: <0.001), in a mean procedural time of 13.5+11.6 minutes, and 24.7+14.9 minutes, respectively (p value: <0.001). No differences were found in other adverse events, clinical success, stent patency, or overall mortality

Conclusion

EUS-CDS is superior to ERCP in reducing post-procedural acute pancreatitis risk, without significantly affecting the overall risk of adverse events. Additionally EUS-CDS showed improved technical success, and comparable clinical efficacy. These results support the use of EUS-CDS as the potential preferred primary approach in patients with dilated CBD (NCT04099862).

Introduction

Computer-aided diagnosis (CAD) systems are widely implemented in the medical field for the analysis of medical images. PolyDeep is a CAD system that has demonstrated its efficacy in lesion detection.

Aims & Methods

The aim of this study is to determine whether PolyDeep increases the adenoma detection rate (ADR) in the context of expert endoscopists participating in a regional, population-based colorectal cancer screening program in Spain. PolyDeep Advance 3 (NCT05513261) is a multicentric, randomized controlled clinical trial. For the primary endpoint, we aimed to assess whether the ADR is superior in PolyDeep-assisted colonoscopy compared to conventional colonoscopy. As secondary endpoints, we aimed to determine whether PolyDeep-assisted colonoscopy improves the polyp detection rate (PDR), serrated lesion detection rate (SLDR), advanced serrated lesion detection rate (ASLDR), and advanced adenoma detection rate (AADR). We included participants who underwent colonoscopy for screening (i.e. those with a positive faecal immunochemical occult blood test – FIT+) or for surveillance after resection of advanced adenomas. We compared both groups using the chi-square and t-Student test.

Results

Between November 2023 and May 2024, we recruited 857 patients, of whom 30 were excluded. The baseline characteristics of the 827 patients included in the analysis were similar (male: 59.3%, screening colonoscopy: 66.7%, mean age: 61.7 ± 6.5 years, withdrawal time: 10:49 ± 04:32 minutes, colorectal cancer incidence: 2.8%). However, there were significant differences between both groups in the Boston Bowel Preparation Scale (conventional colonoscopy: 7.7 ± 1.3 vs. PolyDeep-assisted colonoscopy: 7.4 ± 1.3, p = 0.01). Regarding ADR, we did not find statistically significant differences between conventional and PolyDeep-assisted colonoscopy (57.7% vs. 60.8%, p = 0.4). Similarly, for the secondary endpoints, there were no significant differences in PDR (68.7% vs. 69.6%, p = 0.8), SLDR (32.0% vs. 29.4%, p = 0.5), ASLDR (5.3% vs. 5.1%, p = 1.0), or AADR (24.5% vs. 23.6%, p = 0.8). In Table 1, we described lesion detection rates between both groups by indication (i.e., FIT+ or surveillance).

Conclusion

In the context of expert endoscopists PolyDeep did not increase the ADR.