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Introduction

Upadacitinib, an oral, selective, and reversible Janus kinase inhibitor (JAKi), vedolizumab (VEDO), an α4β7 integrin monoclonal antibody, ustekinumab (UST), an IL-12/23 inhibitor, and tofacitinib (TOFA), a pan JAKi, are all approved therapies for patients with moderately to severely active ulcerative colitis (UC). Evidence on their comparative efficacy and safety during maintenance are lacking.

Aims & Methods

Separate placebo (PBO)-anchored matching-adjusted indirect comparisons (MAIC) of the efficacy and safety of UPA vs VEDO, UST, and TOFA during maintenance were conducted. Induction responders were rerandomized in the phase 3 maintenance studies to oral UPA 15 or 30 mg once daily or PBO in U-ACHIEVE, VEDO 300 mg intravenous or PBO in GEMINI-1, UST 90 mg subcutaneous or PBO in UNIFI, and oral TOFA 5 mg twice daily or PBO in OCTAVE Sustain. Efficacy outcomes at maintenance weeks 44(UST)/46(VEDO)/52(UPA/ TOFA) were adjusted by the likelihood of induction clinical response to assess treat-through efficacy in the intent-to-treat population. Outcomes included clinical response (decrease in Full Mayo score [FMS] ≥3 points and ≥30% and decrease in rectal bleeding score [RBS] of ≥1 or an absolute RBS of 0 or 1), clinical remission (FMS ≤2 with no subscore >1, plus RBS of 0 for UPA vs TOFA [remission]), and endoscopic improvement (EI, endoscopic subscore 0 or 1). Safety outcomes included adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation (except for UPA vs VEDO). Select baseline characteristics from the UPA trial were weighted to match the VEDO, UST, or TOFA trials, separately. Numbers needed to treat or harm (NNT or NNH) were calculated as the inverse of the difference in proportions of patients demonstrating each outcome between UPA and VEDO, UST, or TOFA to assess benefit-risk.

Results

Greater proportions of patients receiving UPA 15 mg vs VEDO demonstrated clinical response, clinical remission, and EI (difference in proportions>0; p<0.05) and achieved clinical response and EI with UPA vs TOFA (p<0.05). Significantly greater proportions of patients receiving UPA 30 mg vs VEDO, UST, or TOFA demonstrated all efficacy outcomes (difference in proportions>0; p<0.05), with NNTs <8.7. Difference in proportions of AEs, SAEs, and AEs leading to discontinuation were small and not statistically different between both doses of UPA and the studied comparator therapies.

Conclusion

After 1 year of maintenance, greater clinical efficacy and similar safety was observed with UPA vs VEDO, UST, or TOFA in patients with active UC, suggesting a favourable benefit-risk profile of UPA vs other advanced therapies. Differences in trial design, such as variable timing of rerandomization and dosages and assessment times, and endpoint definitions may persist and impact responder profiles.

Efficacy^a Outcome	Treatment comparisons (UPA15 vs comparator)	Proportion^b	Difference in proportions^c	NNT^d	Treatment comparisons (UPA30 vs comparator)	Proportion^b	Difference in proportions^c	NNT^d
Clinical response	UPA15/ PBO VEDO300/ PBO UPA15 vs VEDO300 UPA15/ PBO UST90/ PBO UPA15 vs UST90 UPA15/ PBO TOFA5/ PBO UPA15 vs TOFA5	54.3%/ 5.6% 26.6%/ 6.1% — 44.6%/ 4.6% 43.9%/ 14.0% — 39.9%/ 3.8% 29.7%/ 6.2% —	0.488 0.206 0.282* 0.400 0.299 0.101 0.361 0.234 0.127	2.1 4.9 3.6 2.6 3.4 10.0 2.8 4.3 7.9	UPA30/ PBO VEDO300/ PBO UPA30 vs VEDO300 UPA30/ PBO UST90/ PBO UPA30 vs UST90 UPA30/ PBO TOFA5/ PBO UPA30 vs TOFA5	57.6%/ 5.6% 26.6%/ 6.1% — 52.4%/ 4.6% 43.9%/ 14.0% — 52.8%/ 3.8% 29.7%/ 6.2% —	0.520 0.206 0.314* 0.478 0.299 0.178* 0.490 0.234 0.255***	2.0 4.9 3.2 2.1 3.4 5.7 2.1 4.3 4.0
Clinical remission (or remission for UPA vs TOFA)	UPA15/ PBO VEDO300/ PBO UPA15 vs VEDO300 UPA15/ PBO UST90/ PBO UPA15 vs UST90 UPA15/ PBO TOFA5/ PBO UPA15 vs TOFA5	37.5%/ 4.3% 19.7%/ 4.1% — 31.2%/ 2.9% 27.0%/ 7.5% — 25.3%/ 2.2% 19.8%/ 3.4% —	0.332 0.156 0.176* 0.284 0.195 0.088 0.231 0.163 0.067	3.1 6.4 5.7 3.6 5.2 11.4 4.4 6.2 14.9	UPA30/ PBO VEDO300/ PBO UPA30 vs VEDO300 UPA30/ PBO UST90/ PBO UPA30 vs UST90 UPA30/ PBO TOFA5/ PBO UPA30 vs TOFA5	43.3%/ 4.3% 19.7%/ 4.1% — 34.0%/ 2.9% 27.0%/ 7 .5% — 32.5%/ 2.2% 19.8%/ 3.4% —	0.390 0.156 0.233** 0.311 0.195 0.116* 0.302 0.163 0.139***	2.6 6.4 4.3 3.3 5.2 8.7 3.4 6.2 7.3
EI	UPA15/ PBO VEDO300/ PBO UPA15 vs VEDO300 UPA15/ PBO UST90/ PBO UPA15 vs UST90 UPA15/ PBO TOFA5/ PBO UPA15 vs TOFA5	48.9%/ 4.5% 24.3%/ 5.0% — 35.8%/ 3.2% 31.6%/ 9.0% — 31.1%/ 2.6% 21.5%/ 4.0% —	0.444 0.193 0.252* 0.326 0.226 0.100** 0.285 0.175 0.110*	2.3 5.2 4.0 3.1 4.5 10.1 3.6 5.8 9.1	UPA30/ PBO VEDO300/ PBO UPA30 vs VEDO300 UPA30/ PBO UST90/ PBO UPA30 vs UST90 UPA30/ PBO TOFA5/ PBO UPA30 vs TOFA5	51.6%/ 4.5% 24.3%/ 5.0% — 41.7%/ 3.2% 31.6%/ 9.0% — 42.0%/ 2.6% 21.5%/ 4.0% —	0.471 0.193 0.278* 0.385 0.226 0.159 0.394 0.175 0.219***	2.2 5.2 3.6 2.6 4.5 6.3 2.6 5.8 4.6
Safety^e Outcome	Treatment comparisons (UPA15 vs comparator)	Proportion^b	Difference in proportions^c	NNH^d	Treatment comparisons (UPA30 vs comparator)	Proportion^b	Difference in proportions^c	NNH^d
AEs	UPA15/ PBO VEDO300/ PBO UPA15 vs VEDO300 UPA15/ PBO UST90/ PBO UPA15 vs UST90 UPA15/ PBO TOFA5/ PBO UPA15 vs TOFA5	79.7%/ 72.1% 82.0%/ 84.0% — 78.4%/ 77.2% 77.3%/ 78.9% — 78.6%/ 80.3% 72.2%/ 75.3% —	0.076 –0.020 0.096 0.013 –0.016 0.029 –0.017 –0.031 0.014	13.1 –50.0 10.3 80.0 –62.4 35.0 –59.1 –32.2 70.9	UPA30/ PBO VEDO300/ PBO UPA30 vs VEDO300 UPA30/ PBO UST90/ PBO UPA30 vs UST90 UPA30/ PBO TOFA5/ PBO UPA30 vs TOFA5	72.6%/ 72.1% 82.0%/ 84.0% — 71.1%/ 77.2% 77.3%/ 78.9% — 77.0%/ 80.3% 72.2%/ 75.3% —	0.005 –0.020 0.025 –0.061 –0.016 –0.045 –0.033 –0.031 –0.002	204.0 –50.0 40.1 –16.3 –62.4 –22.0 –30.3 –32.2 –500.0
SAEs	UPA15/ PBO VEDO300/ PBO UPA15 vs VEDO300 UPA15/ PBO UST90/ PBO UPA15 vs UST90 UPA 15/ PBO TOFA 5/ PBO UPA15 vs TOFA5	11.1%/ 11.6% 8.0%/ 16.0% — 7.1%/ 13.8% 8.5%/ 9.7% — 7.8%/ 10.6% 5.1%/ 6.6% —	–0.006 –0.080 0.075 –0.067 –0.012 –0.055 –0.028 –0.015 –0.013	–181.8 –12.5 13.4 –14.9 –83.3 –18.1 –35.5 –66.6 –76.3	UPA30/ PBO VEDO300/ PBO UPA30 vs VEDO300 UPA30/ PBO UST90/ PBO UPA30 vs UST90 UPA30/ PBO TOFA5/ PBO UPA30 vs TOFA5	1.0%/ 11.6% 8.0%/ 16.0% — 4.3%/ 13.8% 8.5%/ 9.7% — 4.2%/ 10.6% 5.1%/ 6.6% —	–0.106 –0.080 –0.026 –0.094 –0.012 –0.082 –0.064 –0.015 –0.049	–9.4 –12.5 –38.1 –10.5 –83.3 –12.1 –15.7 –66.6 –20.6
AEs leading to discontinuation^f	UPA15/ PBO VEDO300/ PBO UPA15 vs VEDO300 UPA15/ PBO UST90/ PBO UPA15 vs UST90 UPA15/ PBO TOFA5/ PBO UPA15 vs TOFA5	N/A N/A N/A 2.8%/ 12.3% 2.8%/ 11.4% — 4.2%/ 9.8% 9.1%/ 18.7% —	N/A N/A N/A –0.095 –0.086 –0.009 –0.055 –0.096 0.041	N/A N/A N/A -10.5 -11.6 –116.2 –18.0 –10.4 24.6	UPA30/ PBO VEDO300/ PBO UPA30 vs VEDO300 UPA30/ PBO UST90/ PBO UPA30 vs UST90 UPA30/ PBO TOFA5/ PBO UPA30 vs TOFA5	N/A N/A N/A 3.9%/ 12.3% 2.8%/ 11.4% — 4.9%/ 9.8% 9.1%/ 18.7% —	N/A N/A N/A –0.084 –0.086 0.002 –0.049 –0.096 0.047	N/A N/A N/A -11.9 -11.6 416.6 –20.5 –10.4 21.0
^aFor efficacy outcomes, treat-through results are calculated as: (induction MAIC response rate) x (maintenance MAIC efficacy rate). Standard errors were calculated as square root of the variance for product of two independent variables (i.e., induction MAIC response rate and maintenance MAIC efficacy rate). ^bUPA data are individual patient-level results while VEDO, UST, or TOFA data are aggregated published results. Core baseline characteristics used in the weighting included age, gender, extent and duration of disease, total Mayo score, and prior UC medication/biologic usage. ^cDifference in proportions between advanced therapies (UPA arms vs comparators) are shown in bold; otherwise, differences are shown vs placebo. ^dPositive (negative) NNTs denote greater (lower) efficacy of UPA vs comparator, and positive (negative) NNHs denote greater (lower) safety risk of UPA vs comparator. ^eBroad safety outcomes are included because they were collected consistently across clinical trials. ^fData were not available in the VEDO GEMINI-1 maintenance phase 3 trial. P‑value equals <0.05, ≤0.01, **<0.001. AEs, adverse events; EI, endoscopic improvement; N/A, not applicable; NNH, number needed to harm; NNT, number needed to treat; PBO, placebo; SAEs, serious adverse events; UPA15, upadacitinib 15 mg; UPA30, upadacitinib 30 mg; UST90, ustekinumab 90 mg; TOFA5, tofacitinib 5 mg; VEDO300, vedolizumab 300 mg.

Disclosure

AbbVie funded this study and participated in the study design; study research; collection, analysis and interpretation of data; and writing, reviewing, and approving of this publication. All authors had access to the data, and participated in the development, review, and approval, and in the decision to submit this publication. No honoraria or payments were made for authorship. Medical writing services provided by Brandy Menges, PhD of Fishawack Facilitate Ltd, part of Fishawack Health, and funded by AbbVie.

Walter Reinisch has received support for speaker, consultant, and/or advisory board member for Abbott, AbbVie, Aesca, Algernon, Amgen, AM Pharma, AMT, AOP Orphan, Aptalis, Arena, Astellas, Avaxia, AZ, BI, Bioclinica, Biogen IDEC, BMS, Celgene, Cellerix, Celltrion, Centocor, Chemocentryx, Covance, Danone Austria, DSM, Elan, E&Y, Falk, Ferring, Galapagos, Genentech, Gilead, Grünenthal, ICON, Immundiagnostik, Index, Inova, Janssen, J&J, Kyowa Hakko Kirin, Lilly, Lipid, LivaNova, Mallinckrodt, Medahead, MedImmune, Millennium, Mitsubishi Tanabe, MSD, Nash, Nestle, Nippon Kayaku, Novartis, Ocera, OMass, Otsuka, Parexel, PDL, Periconsulting, Pharmacosmos, Philip Morris Institute, Pfizer, PLS Education, P&G, Prometheus, Protagonist, Provention, Robarts Clinical Trials, Roland Berger, Sandoz, Schering-Plough, Second Genome, Seres, Setpointmedical, Sigmoid, Sublimity, Takeda, Therakos, Theravance, Tigenix, UCB, Vifor, Yakult, Zealand, Zyngenia, and 4SC.
Gil Y. Melmed is a consultant for AbbVie, Arena, BI, BMS, Ferring, Fresenius Kalbi, Genentech, Gilead, Lilly, Janssen, Pfizer, Prometheus, Samsung Bioepis, Takeda, and Techlab.
Hiroshi Nakase reports receiving personal fees from Abbvie Inc., Kissei Pharmaceutical Co., Ltd., KYORIN Pharmaceutical Co., Ltd, Mitsubishi Tanabe Pharma Corporation, Janssen Pharmaceutical K.K, Takeda Pharmaceutical Co., Ltd., Pfizer Japan Inc., Celgene K.K., EA Pharma Co., Ltd., Zeria Pharmaceutical CO., Ltd., Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., D Daiichi Sankyo Co., Ltd JIMRO Co., Ltd., as well as grants for commissioned/joint research from Hoya Group Pentax Medical, Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd.
Jakob Seidelin has received research grants from Takeda and Janssen, and is a national coordinator of studies from AbbVie, Arena Pharmaceuticals, Ely Lilly, and Boehringer Ingelheim.
Christopher Ma has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Pendopharm, Pfizer, Prometheus Biosciences Inc., Roche, Sanofi, Takeda, Tillotts Pharma; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, Organon, Pendopharm, Pfizer, Takeda; royalties from Springer Publishing; research support from Ferring, Pfizer.
Si Xuan, Dapo Ilo, Lani Wegrzyn, Gwen Levy, Yuri Sanchez Gonzalez are employees of AbbVie and may own stock or options.
Jacinda Tran is a funded PhD student at the University of and contractor for AbbVie.
Remo Panaccione has received support for consulting, speaker, advisory board member for, and/or research/educational support from: Abbott, AbbVie, Abbivax, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Viatris, Ventyx, UCB.

COMPARATIVE EFFICACY AND SAFETY OF UPADACITINIB, VEDOLIZUMAB, USTEKINUMAB AND TOFACITINIB AFTER ONE-YEAR MAINTENANCE THERAPY FOR MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: 3 MATCHING-ADJUSTED INDIRECT COMPARISONS

Walter Reinisch 1, Gil Y. Melmed 2, Hiroshi Nakase 3, Jacob Seidelin 4, Christopher Ma 5, Si Xuan 6, Jacinda Tran 7, Dapo Ilo 6, Lani Wegrzyn 6, Gwen Levy 6, Yuri Sanchez Gonzalez 6, Remo Panaccione 8

1 Medical University of Vienna, Wien, Austria

2 Cedars-Sinai Medical Center, Los Angeles, United States

3 Sapporo Medical University School of Medicine, Sapporo, Japan

4 Copenhagen University Hospital - Gentofte and Herlev, Herlev, Denmark

5 University of Caglary, Calgary, Canada|||University of Calgary, Calgary, Canada

6 AbbVie, Inc., North Chicago, United States

7 AbbVie, Inc., North Chicago, United States|||University of Washington, Seattle, United States

8 University of Calgary, Calgary, Canada

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Podcast Episode

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AI Essentials: Lower GI (UEG Talks rewind)

Louis Liu, Alanna Ebigbo, Pradeep Mundre

Topics

Endoscopy

Published

2025

UEG Podcast Episode

UEG Podcast

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Complications in endoscopy with Srisha Hebbar Part 2

Srisha Hebbar, Pradeep Mundre

Topics

Endoscopy

Published

2025

UEG Presentation

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Endoscopy: How good are you at detecting cancer?

Prateek Sharma 1

1 University of Kansas School of Medicine Dept. of Gastroenterology, Leawood, United States of America

Event

UEG Week Vienna 2024

Topics

Digestive Oncology Endoscopy Surgery

Session

Quality in upper GI: The good, the bad and the ugly

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Presentation

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HOT VERSUS COLD-SNARE ENDOSCOPIC MUCOSAL RESECTION FOR NON-AMPULLARY DUODENAL LESIONS: CONSOLIDATING THE COLD REVOLUTION INTO CLINICAL PRACTICE

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Introduction

Endoscopic mucosal resection (EMR) has increasingly gained acceptance as a minimally invasive intervention for the treatment of duodenal lesions. Despite the overall good results, there can be significant morbidity associated with performing EMR in the duodenum. Data comparing hot- and cold-snare approaches in the duodenum are currently scarce.

Aims & Methods

Our aim was to assess the efficacy and safety of hot-snare EMR (H-EMR) versus cold-snare EMR (C-EMR) for the resection of non-ampullary duodenal lesions. A prospectively collected database of duodenal lesions treated using EMR at a single tertiary medical center between 2010 and 2023 was performed. Patient demographics, lesion and procedure characteristics, outcomes, and adverse events were analyzed using R statistical software. The lesion size and procedural time were analyzed using the Mann-Whitney U test while clinical outcomes were analyzed using the Fisher’s exact test. Cost savings were calculated from the averted use of clips.

Results

	Hot-snare EMR (n=46)	Cold-snare EMR (n=25)	P-value
Age, mean ± SD, y	66.72 ± 11.49	63.12 ± 11.61	0.12
Male gender, n (%)	20 (43.5)	17 (68.0)	0.08
ASA classification Class 1, n (%) Class 2, n (%) Class 3, n (%)	2 (4.4) 29 (63.0) 15 (32.6)	0 (0.0) 17 (68.0) 8 (32.0)	0.56
Antithrombotic use, n (%) Antiplatelet other than aspirin Anticoagulation Both	4 (9.1) 3 (6.8) 0 (0.0)	0 (0.0) 1 (4.3) 0 (0.0)	0.50
Size (mm)	25.93±15.53	21.68±38.40	0.003
Adenomatous lesions, n (%) Cancer in final histology	34 (73.9) 1 (2.2)	22 (88.0) 0 (0.0)	0.28 0.20
Procedural time, min	62.21±37.00	50.24±35.50	0.12
Technique En-bloc resection Submucosal lifting APC or CAST or STSC Adjunctive Hemoclips Hemostatic agent (e.g., Purastat or Hemospray)	31 (67.4) 44 (95.7) 16 (34.8) 25 (54.4) 3 (6.5)	20 (80.0) 23 (92.0) 5 (20.0) 4 (16.0) 3 (12.0)	0.29 0.61 0.28 0.002
Clinical outcomes, n (%) Technical success Immediate perforation Delayed perforation Delayed bleeding Stricture formation Recurrence	46 (100.0) 1 (2.2) 0 (0.0) 4 (9.1) 0 (0.0) 7 (22.6)	25 (100.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (15.4)	1.00 1.00 1.00 0.29 1.00 0.70

APC: Argon Plasma Coagulation
ASA: American Society of Anesthesiologists
CAST: Cold-forceps Avulsion with adjuvant Snare-Tip soft coagulation
STSC: Snare-Tip Soft Coagulation

Seventy-one cases of non-ampullary duodenal lesions resected using the EMR technique were included (46 H-EMR; 25 C-EMR). Fifty-one lesions were resected en-bloc (31 H-EMR vs 20 C-EMR) while 20 lesions were resected in a piecemeal fashion (15 H-EMR vs 5 C-EMR). Similar demographics, lesion, and procedure characteristics were observed in both cohorts. Technical success was 100%, and no delayed perforations occurred in either cohort. Lesions resected via H-EMR had higher rates of immediate perforation (2.2% vs 0%; p=1.0) and delayed bleeding (9.1% vs 0%; p=0.28) compared to C-EMR. Interestingly, recurrence rates were higher in the H-EMR arm (15.2% vs 8%; p=0.70). C-EMR technique achieved a crude cost saving from clips alone of USD $135 per patient compared to the H-EMR technique.

Conclusion

While both cohorts demonstrated excellent technical success, there was a trend towards lower adverse events and recurrence rates, as well as cost savings, when C-EMR technique was used for non-ampullary duodenal lesions. Larger prospective comparative trials are warranted to bolster the present evidence and shape the approach of tackling these rarely encountered but clinically significant lesions safely and effectively.

HOT VERSUS COLD-SNARE ENDOSCOPIC MUCOSAL RESECTION FOR NON-AMPULLARY DUODENAL LESIONS: CONSOLIDATING THE COLD REVOLUTION INTO CLINICAL PRACTICE

Andrawus Beany 1, Enrik John Aguila 2, Anna Agnieszka Wawer 3, Dauda Bawa 4, Jin Tan 3, Rajvinder Singh 5

1 Rambam Health Care Campus, Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel|||Lyell McEwin Hospital, Elizabeth Vale, Australia

2 Lyell McEwin Hospital, Elizabeth Vale, Australia|||St. Luke's Medical Center Global City, Pasig City, Philippines

3 Lyell McEwin Hospital, Elizabeth Vale, Australia|||University of Adelaide, School of Medical Sciences, Adelaide, Australia

4 Lyell McEwin Hospital, Elizabeth Vale, Australia

5 University of Adelaide, School of Medical Sciences, Adelaide, Australia|||Lyell McEwin Hospital, Elizabeth Vale, Australia

Event

UEG Week Vienna 2024

Topics

Digestive Oncology Endoscopy Small Intestine & Nutrition Stomach & H. Pylori Oesophagus

Submission format

Abstract

Session

Upper GI endoscopy: From diagnosis to treatment

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Presentation

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THE IMPACT OF SCREENING COLONOSCOPY KEY PERFORMANCE INDICATORS ON THE RISK OF FUTURE COLORECTAL CANCER AND ADVANCED POLYPS

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Introduction

Polyp detection rates are considered surrogate indicators of colonoscopy quality. Current evidence suggests that improving these in low detectors may reduce the risk of post colonoscopy colorectal cancer (PCCRC). It is unclear whether an upper threshold exists above which this becomes less clinically meaningful. The aim of this study was to assess the impact of KPIs in a high polyp detector group on the future risk of advanced polyps and colorectal cancer diagnoses within 3 years of screening colonoscopy. The PCCRC rate and number of interval cancers and advanced polyps detected were also described.

Aims & Methods

This was a retrospective cohort study of patients undergoing screening colonoscopy. Endpoints of advanced polyps or colorectal cancer and were identified by analysis of routine linked healthcare data through the Secure Anonymised Information Linkage (SAIL) databank. A multivariate cox regression analysis assessed the impact of colonoscopist performance indicators on outcomes of future diagnoses of advanced polyps or colorectal cancer.

Results

5807 patients were included with a median follow-up of 60.1 months. There were 1.5% interval advanced polyps and 0.9% colorectal cancers identified with a median time to diagnosis of 19.8 and 39.2 months respectively. PCCRC rate was 3.8%. The median polyp detection rates were 62.2% with an adenoma detection rate of 50.9% amongst the colonoscopists. There was minimal variation in outcomes of advanced polyp or colorectal cancer diagnoses in these high detectors with no impact demonstrated of higher thresholds of the assessed key performance indicators on this.

Conclusion

It appears a threshold exists above which increasing performance indicators may not translate to better clinical outcomes. This is the first evidence assessing this in a group of high polyp detectors. The thresholds suggested may be utilised in endoscopy training, guiding surveillance recommendations, new technology and screening programmes.

Disclosure

N/A

THE IMPACT OF SCREENING COLONOSCOPY KEY PERFORMANCE INDICATORS ON THE RISK OF FUTURE COLORECTAL CANCER AND ADVANCED POLYPS

Jody Parker 1, Giles Greene 2, Jared Torkington 1, SUNIL DOLWANI 3

1 Cardiff and Vale University Health Board, Cardiff, United Kingdom

2 Welsh Cancer Intelligence and Surveillance Unit, Cardiff, United Kingdom

3 Cardiff University, Cardiff, United Kingdom

Event

UEG Week Vienna 2024

Topics

Colorectal Digestive Oncology Endoscopy

Submission format

Abstract

Session

Screening colonoscopy: How to save lives

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Poster

Standard Poster

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Introduction

Biliary adverse events manifest in approximately 25% of liver transplant recipients. Among these, anastomotic biliary strictures (ABS) are the most prevalent, occurring in approximately 6%‐12% of cases and can be successfully managed endoscopically.

Aims & Methods

Our study aims to present the evolution of method and long-term results of placing multiple plastic stents to treat ABS after orthotopic liver transplantation (OLT). All consecutive patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) for liver transplantation-related biliary complications at our Endoscopy Unit between July 1994 and September 2022 were retrospectively identified. The analysis focused only on the patients diagnosed with ABS undergoing dilatation by a progressively increasing number of plastic stents. Follow-up after stent removal was obtained by office visit, telephone contact with the patient or referring physician and extended to this year or until patient succumbed.

Results

Two hundred and ninety-five patients referred by 4 Liver Transplant Units underwent ERCP in need of endoscopic treatment for biliary complications after liver transplantation. However only 151 represented our intention-to-treat group with ABS. Out of these, 21 patients were excluded because of split liver transplantation, the use of metallic stents or incomplete endoscopic treatment. The mean age of the remaining 130 patients was 56 ± 9 years old and included 107 males and 23 females. We divided these patients in 2 groups according to similar timeframes, 28 ABS patients being treated before 2008 and 102 patients after 2008. In the first group the median number of stents was 4 (range 2-7), with a median of 3 ERCPs (range 2-5) per patient. Patients treated after 2008 received a median number of 6 stents (range 3-9) (p = .000, Mann-Whitney U), with a median of 4 ERCPs (range 3-7) (p = .002, Mann-Whitney U). The mean treatment duration was 15.3 ± 16.7 months in the first group and 14 ± 10 months in the second. Stricture recurrence was noted in 14.2% of patients treated before 2008 versus 4.9% after 2008. Nevertheless, the follow-up period was 10.6 ± 7.5 years for the first group and 4.7 ± 4 years in the second group.

Conclusion

The endoscopic treatment with multiple plastic stents proved to be effective for the majority of patients with ABS after OLT. In the last decade, the endoscopists shifted towards a more aggressive treatment strategy, with an increased number of stents and a reduced period between stent replacement procedures. This intensive approach seems also to underline a lower stricture recurrence rate however a longer follow-up period needs to be considered for the patients treated after 2008.

EVOLUTION OF ENDOSCOPIC MANAGEMENT FOR ANASTOMOTIC BILIARY STRICTURES AFTER LIVER TRANSPLANTATION: A TWO-DECADE RETROSPECTIVE STUDY

Sara Sofia De Lucia 1, Maria Mihaela Birligea 2, Tommaso Schepis 3, Vincenzo Perri 3, Pietro Familiari 3, Ivo Boskoski 3, Rosario Landi 1, Vincenzo Bove 1, Marzia Montalbano 4, Giuseppe Maria Ettorre 5, Nicola Guglielmo 5, Alfonso Wolfango Avolio 3, Salvatore Agnes 3, Guido Costamagna 1, Cristiano Spada 3, Andrea Tringali 3

1 Catholic University, Rome, Italy

2 Colentina Clinical Hospital and "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania

3 Fondazione Policlinico Gemelli IRCCS, Rome, Italy

4 INMI L. Spallanzani, Rome, Italy

5 Polo Ospedaliero Interaziendale Trapianti Azienda San Camillo and INMI L. Spallanzani, Rome, Italy

Conference

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

Managing bile duct disease (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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