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OPTIMIZING DIAGNOSIS: ISOLATED HILAR/EXTRAHEPATIC IGG4-RELATED SCLEROSING CHOLANGITIS WITH REVISED CLINICAL DIAGNOSTIC CRITERIA 2020: A JAPANESE MULTICENTER STUDY

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Introduction

In more than 90% of cases, IgG4-related sclerosing cholangitis (IgG4-SC) is linked with autoimmune pancreatitis (AIP)¹⁾, facilitating its diagnosis. Without AIP, differentiating IgG4-SC from malignant biliary obstruction is challenging, leading to unnecessary resections ²⁾. Although diagnostic criteria for IgG4-SC were established in 2012 ³⁾and revised in 2020 ⁴⁾, validation is lacking.

Aims & Methods

We retrospectively collected data from 17 Japanese high-volume centers on patients with isolated IIgG4-SC. We excluded distal-type isolated IgG4-SC, previously characterized by Nakazawa, due to challenges in identifying distal intra-pancreatic biliary strictures without pancreatic involvement. Diagnosis of isolated IgG4-SC was based on the 2012 and 2020 criteria, with evaluation of symptoms, serum markers, imaging, and prognosis.

Results

A total of 53 patients with isolated IgG4-SC were included in the study, categorized into two groups based on the primary location of the lesion: hilar type (n = 40) and extrahepatic type (n = 13). Ten patients with hilar-type lesions underwent unnecessary resection due to a lack of awareness regarding the possibility of IgG4-SC. Common findings of endoscopic ultrasound/intraductal ultrasound, such as symmetric mucosal lesions of the bile duct, were observed in both types. The revised 2020 criteria demonstrated utility in diagnosing extrahepatic lesions, not covered by the 2012 criteria. While endoscopic biopsy could not reveal characteristic findings of isolated IgG4-SC, such as storiform fibrosis and obliterative phlebitis, it was useful in detecting infiltration of affected surfaces by IgG4-positive plasma cells. The percentage of patients requiring a steroid trial decreased from 37.7% with the 2012 criteria to 7.6% with the revised 2020 criteria. The revised criteria improved diagnostic specificity from 58.5% to 88.7%.

Conclusion

Our validation of the revised 2020 criteria for diagnosing IgG4-SC holds the potential to mitigate unnecessary surgical interventions in patients with isolated IgG4-SC, classified into hilar and extrahepatic subtypes. These updated criteria can enhance the diagnostic accuracy of isolated IgG4-SC and facilitate the identification of this challenging-to-diagnose condition based on including the imaging findings without sufficient proof by endoscopic biliary forceps biopsy and dependence on a steroid trial.

References

1)Hart PA, Kamisawa T, Brugge WR, Chung JB, Culver EA, Czako L, et al. Long-term outcomes of autoimmune pancreatitis: a multicenter, international analysis. Gut. 2013; 62:1771-76.
2)Takagi Y, Kubota K, Takayanagi T, et al. Clinical features of isolated proximal‑type immunoglobulin G4‑related sclerosing cholangitis. Digestive endoscopy 2019; 31:422‑30.
3) Ohara H, Okazaki K, Tsubouchi H, et al. Clinical diagnostic criteria of IgG4-related sclerosing cholangitis 2012. J Hepatobiliary Pancreat Sci. 2012; 19: 536-42
4) Nakazawa T, Kamisawa T, Okazaki K, et al. Clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020. J Hepatobiliary Pancreat Sci. 2021 28: 235-42.

OPTIMIZING DIAGNOSIS: ISOLATED HILAR/EXTRAHEPATIC IGG4-RELATED SCLEROSING CHOLANGITIS WITH REVISED CLINICAL DIAGNOSTIC CRITERIA 2020: A JAPANESE MULTICENTER STUDY

Eisuke Iwasaki 1, Kensuke Kubota 2, Takuya Ishikawa 3, Masaki Kuwatani 4, Mamoru Takenaka 5, Takuji Iwashita 6, Atsuhiro Masuda 7, Tsukasa Ikeura 8, Akira Nakamura 9, Atsushi Tanaka 10, Hiroyuki Isayama 11, Yoshiki Hirooka 12, Kenji Hirano 13, Shomei Ryozawa 14, Takeshi Ogura 15, Toshio Fujisawa 16, Yusuke Kurita 2, Kazuhiro Kikuta 17, Nobuhiko Hayashi 18, Atsushi Masamune 17, Ichiro Yasuda 18

1 Keio University School of Medicine, Tokyo, Japan

2 Yokohama City University Hospital, Yokohama, Japan

3 Nagoya University Graduate School of Medicine, Nagoya, Japan

4 Hokkaido University Hospital, Sapporo, Japan

5 Kindai University, Osaka, Japan

6 Gifu University Hospital, Gifu, Japan

7 Kobe graduate school of medicine, Kobe, Japan

8 Kansai Medical University, Hirakata, Japan

9 Shinshu university, Matsumoto, Japan

10 Teikyo University School of Medicine, Tokyo, Japan

11 Juntendo University, Tokyo, Japan

12 Fujita Health University, Toyoake, Japan

13 Tokyo Takanawa Hospital, Tokyo, Japan

14 Saitama Medical University International Medical Center, Saitama, Japan

15 Osaka Medical and Pharmaceutical University, Osaka, Japan

16 Juntendo University Graduate School of Medicine, Tokyo, Japan

17 Tohoku University Graduate School of Medicine, Sendai, Japan

18 University of Toyama, Toyama, Japan

Event

UEG Week Vienna 2024

Topics

Digestive Oncology Endoscopy Hepatobiliary Radiology & Imaging

Submission format

Abstract

Session

Advanced ERCP technology and outcomes

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Navigating the IL-23 universe: breaking frontiers in ulcerative colitis (Johnson and Johnson) (Complete Session)

Alexander Moschen 1, Catherine Reenaers 2, David T. Rubin 3, Joana Torres 4

1 Kepler University Hospital, Johannes Kepler University Linz, Graz, Austria

2 University Hospital Liège, Liege, Belgium

3 The University of Chicago Medicine, Chicago, United States of America

4 Division of Gastroenterology, Hospital Beatriz Ângelo, Loures, Portugal

Event

UEG Week Berlin 2025

Session

Navigating the IL-23 universe: breaking frontiers in ulcerative colitis (Johnson and Johnson)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Panel discussion: A 360-degree appraisal of acute pancreatitis

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Endoscopy Pancreas Radiology & Imaging

Session

A 360-degree appraisal of acute pancreatitis

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Presentation

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MULTICENTER, RANDOMIZED NON-INFERIORITY TRIAL COMPARING TRANSANAL MINIMAL INVASIVE SURGERY (TAMIS) AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR RESECTION OF NON-PEDUNCULATED RECTAL LESIONS (TRIASSIC STUDY)

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Introduction

Transanal Minimally Invasive Surgery (TAMIS) and Endoscopic Submucosal Dissection (ESD) are minimally invasive techniques for en bloc resection of large non-pedunculated rectal lesions. While TAMIS has been widely adopted in the Netherlands, ESD uptake has been slower. No randomized trials have compared these methods, leaving the choice of technique dependent on local expertise rather than evidence.

Aims & Methods

This multicenter-randomized non-inferiority trial (NTR7281) aimed at comparing TAMIS and ESD regarding effectiveness, safety, patient burden, and costs. In total, 198 patients with non-pedunculated rectal lesions >2 cm, located ≤15 cm from the anal verge, were included. Patients were randomized in a 1:1 ratio to TAMIS or ESD, with stratification by polyp size (20–40 mm or >40 mm) and distance from the dentate line (<10 mm, 10–99 mm, 100–150 mm), after an expert panel had judged the lesions suitable for inclusion. Exclusion criteria included deep submucosal invasion on endoscopy or imaging (with endoscopy prioritized in case of discordant findings), prior endoscopic resection attempt, and an unfavorable risk-benefit ratio for local treatment (e.g., poor general condition or very short life expectancy). The primary endpoint was cumulative local recurrence at 12 months (non-inferiority margin: 6%). Secondary endpoints included radical (R0) resection rate, complications (AGREE classification), patient burden (COREFO, EQ-5D-5L, QLQ-CR29), and cost-effectiveness. Intention-to-treat analysis was performed.

Results

Of the 198 randomized patients (98 TAMIS, 100 ESD), 5 crossed over from TAMIS to ESD and 1 from ESD to TAMIS. One patient dropped out before treatment as result of non-related metastatic disease. Mean polyp size was 42.0 mm. Mean procedure time was 108.7 minutes for ESD and 78.1 minutes for TAMIS. In total, 156 benign and 41 malignant lesions (39 T1, 2 T2, and 1 T3) were resected. At 12 months, 6 recurrences occurred: 0 (0%) in the ESD group and 6 (6.4%) in the TAMIS group, all benign, with a 6.4% difference favoring ESD (95% CI: -11.8 to -1.5), confirming non-inferiority and also superiority. R0 resection rates were 83% for ESD and 71% for TAMIS (p = 0.047). Overall complication rates were similar (p = 0.33). Colorectal functional outcomes at 12 months were similar and comparable to baseline. Quality-adjusted life years were also similar (0.90 for ESD and 0.91 for TAMIS, p = 0.356). Despite a significant difference in the average initial procedure cost (€2.628 for ESD and €3365 for TAMIS, p < 0.001), the average total cost over 12 months was similar (€7.134 for ESD and €7216 for TAMIS, p = 0.934).

Conclusion

This trial is the first to show that ESD is non-inferior to TAMIS for local recurrence at 12 months in en bloc resection of large non-pedunculated rectal lesions. ESD showed superior radical resection rates and lower initial procedural costs, while both techniques had similar safety profiles, colorectal functional outcomes, quality-adjusted life years, and total 12-month costs.

Disclosure

The TRIASSIC study received funding by ZonMw and Applied medical.
A. Koch received consultancy fees from Microtech, Erbe and Fujifilm

MULTICENTER, RANDOMIZED NON-INFERIORITY TRIAL COMPARING TRANSANAL MINIMAL INVASIVE SURGERY (TAMIS) AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR RESECTION OF NON-PEDUNCULATED RECTAL LESIONS (TRIASSIC STUDY)

Nik Dekkers 1, Daan Verhoeven 1, Jurjen J. Boonstra 1, Leon M.G. Moons 2, Roel Hompes 3, Barbara A.J. Bastiaansen 3, Jurriaan Tuynman 3, Arjun D. Koch 4, Bas L.A.M. Weusten 5, Alaa Alkhalaf 6, Eric J. T. Belt 7, Wilhelmus A. Bemelman 3, Esther C.J. Consten 8, Stijn Crobach 1, Richard Dang 1, Paul Didden 2, Brechtje Grotenhuis 9, Hakimullah Hekmat 10, Elmer Hoekstra 11, Wilbert B. van den Hout 1, Inge Huibregtse 9, Josbert J. Keller 12, jolein van der Kraan 1, Alexandra Langers 1, Monique van leerdam 13, Andreas W.K.S. Marinelli 12, Peter A. Neijenhuis 14, Jikke M.T. Omloo 15, Apollo Pronk 16, Robert Roomer 17, Mar Rodríguez–Girondo 1, Ruud W. M. Schrauwen 18, Matthijs P. Schwartz 8, Mareille Verseveld 17, Wouter De Vos Tot Nederveen Cappel 6, Bob J. van Wely 18, Marinke Westerterp 12, Erik Van Westreenen 6, Eelco J.R. de Graaf 10, Jonathan Y.L. Lai 12, Rogier ten Hove 14, Hans F.A. Vasen 1, Pascal G. Doornebosch 10, James Hardwick 1

1 Leiden University Medical Center, Leiden, Netherlands

2 University Medical Center Utrecht, Utrecht, Netherlands

3 Amsterdam UMC, Amsterdam, Netherlands

4 Erasmus MC Cancer Institute, Rotterdam, Netherlands

5 St Antonius Hospital, Nieuwegein, Netherlands

6 Isala Clinics, Zwolle, Netherlands

7 Albert Schweitzer Hospital, Dordrecht, Netherlands

8 Meander Medical Center, Amersfoort, Netherlands

9 Netherlands Cancer Institute, Amsterdam, Netherlands

10 IJsselland Hospital, Capelle aan den IJssel, Netherlands

11 Hagaziekenhuis, The Hague, Netherlands

12 Haaglanden Medical Center, The Hague, Netherlands

13 Netherlands Cancer Institute, Amsterdam, Netherlands|||Leiden University Medical Center, Leiden, Netherlands

14 Alrijne Hospital, Leiderdorp, Netherlands

15 Gelre Hospitals, Apeldoorn, Netherlands

16 Diakonessenhuis, Utrecht, Netherlands

17 Franciscus Gasthuis, Rotterdam, Netherlands

18 Bernhoven Hospital, Uden, Netherlands

Event

UEG Week Berlin 2025

Topics

Colorectal Endoscopy Surgery

Submission format

Abstract

Session

Improving decision-making in colorectal lesions

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Summary: A 360-degree appraisal of acute pancreatitis

Ilaria Tarantino 1

1 ISMETT, Palermo, Italy

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Endoscopy Pancreas Radiology & Imaging

Session

A 360-degree appraisal of acute pancreatitis

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

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Introduction

Guselkumab (GUS), a dual-acting IL-23p19 subunit inhibitor, is highly efficacious in participants (pts) with Crohn’s disease (CD) after intravenous (IV) or subcutaneous (SC) induction followed by SC maintenance. This analysis characterized pharmacokinetics (PK) and exposure-response (E-R) for efficacy and safety of both administration routes and confirmed assumptions for the development of IV and SC induction formulations.

Aims & Methods

GUS efficacy and safety in pts with moderate to severely active CD were evaluated in the phase 2 GALAXI 1 (200, 600, or 1200 mg IV at week [W]0, W4, and W8),¹ phase 3 GALAXI 2 and 3 (200 mg IV at W0, W4, and W8),² and phase 3 GRAVITI studies (400 mg SC at W0, W4, and W8).³ All studies used treat-through designs and the same SC maintenance dose regimens (100 mg q8w or 200 mg q4w). With an estimated ~50% bioavailability of SC GUS, the 2-fold higher SC induction dose was predicted to provide similar overall exposure and noninferior trough concentrations compared with the IV dose.
To characterize GUS PK, a population PK model was used to simulate exposure metrics for IV and SC induction using individual post-hoc PK parameters and actual pt dosages. Relationships between GUS exposure and select efficacy endpoints (clinical response, clinical remission, and endoscopic response) at week 12 were assessed.

Results

SC induction resulted in higher trough serum concentrations (at W12), lower peak serum concentrations, similar average concentrations (W0–W12), and similar area under the concentration-time curves (W0–W12) vs IV induction (Table). Regardless of induction route (IV or SC) or maintenance regimen, GUS serum concentrations reached steady state by W24.
W12 efficacy outcomes were comparable within GUS concentration quartiles after SC vs IV induction. Although pts with higher serum GUS concentrations tended to achieve greater W12 efficacy outcomes, this trend was no longer evident after accounting for a pt’s drug clearance or the half-life of the drug. W48 outcomes were similar in pts who received the same maintenance regimen, regardless of induction dose route. No positive E-R trends were seen between peak concentration and W12 efficacy endpoints; thus, the higher peak concentration observed with IV induction did not seem to improve efficacy. Across concentration quartiles, the incidence of safety events was comparable between pts who received GUS IV or SC induction regimens. No positive associations between serum concentrations and adverse events (infections, serious infections, and serious adverse events) or abnormal liver function tests were observed.

	GUS 200 mg IV q4w (N=622)	GUS 400 mg SC q4w (N=229)
C_max(µg/mL) Mean (SD)	70.1 (25.1)	27.7 (9.06)
C_{ave, week 0-12}(µg/mL) Mean (SD)	21.4 (7.06)	18.9 (6.47)
C_{trough, week 12}(µg/mL) Mean (SD)	9.76 (5.38)	14.7 (6.65)
AUC_{week 0-12}(day*µg/mL) Mean (SD)	1,800 (593)	1,590 (543)
AUC_{week 0-12}=area under the concentration-time curve from week 0 to week 12 (induction); C_{ave, week 0-12}=average concentration from week 0 to week 12 (induction); C_max=maximum concentration; C_{trough, week 12}=trough concentration at week 12 (induction); IV=intravenous; PK=pharmacokinetic; q4w=every 4 weeks; SC=subcutaneous; SD=standard deviation; W=week.

Conclusion

Average serum GUS concentrations and E-R relationships were similar after IV vs SC induction and had no impact on safety, supporting the use of either administration route and induction dose regimen in CD patients.

References

1. Sandborn WJ, et al. Guselkumab for the treatment of Crohn's disease: induction results from the phase 2 GALAXI-1 study. Gastroenterology. 2022; 162(6):1650-1664.e8.
2. Panaccione R, et al. Efficacy and safety of guselkumab therapy in patients with moderately to severely active Crohn’s disease: results of the GALAXI 2 & 3 phase 3 studies. Gastroenterology. 2024; 166 (5 Supplement):1057b.
3. Hart A, et al. Efficacy and safety of guselkumab subcutaneous induction and maintenance in participants with moderately to severely active Crohn's disease: results from the phase 3 GRAVITI study. Gastroenterology. 2025; S0016-5085(25)00522-0.

Disclosure

Geert D’Haens has served as advisor and/or speaker for Abbvie, Abivax, Agomab, Alimentiv, Anaptys Bio, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Galapagos, Glaxo Smith Kline, Index Pharmaceuticals, Johnson and Johnson, Merck, Polpharm, Prometheus biosciences, Sanofi, Takeda, Tillotts.
Omoniyi J. Adedokun, Tae Eun Yang, Nat A. Terry, Mobolaji Olurinde, Rian Van Rampelbergh, and Marion L. Vetter are employees of Janssen Research & Development (a Johnson & Johnson Company) and may own company stock/stock options.
Bruce E. Sands reports potential conflicts of interest with AbbVie, Abivax, Adiso Therapeutics, Agomab, Alimentiv, Amgen, AnaptysBio, Arena Pharmaceuticals, Artugen Therapeutics, AstraZeneca, Biora Therapeutics, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Evommune, Ferring, Fresenius Kabi, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Janssen, Kaleido, Kallyope, Lilly, Merck, Microbiotica, Mobius Care, Morphic Therapeutics, MRM Health, Pfizer, Nexus Therapeutics, Nimbus Discovery, Odyssey, Therapeutics, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Rasayana Therapeutics, Recludix Therapeutics, Reistone Biotherapeutics, Sun Pharma, Surrozen, Target RWE, Takeda, Teva, Theravance Biopharma, TLL Pharmaceutical, TR1X, Union Therapeutics and Ventyx Biosciences.
Silvio Danese reports potential conflicts of interest with AbbVie, Alimentiv, Allergan, Amgen, AstraZeneca, Athos, Biogen, Boehringer Ingelheim, Celgene, Celltrion, Eli Lilly, Enthera, Ferring, Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity, Takeda, TiGenix, UCB, and Vifor.
Tadakazu Hisamatsu reports potential conflicts of interest with AbbVie, Bristol Myers Squibb, Daiichi-Sankyo, EA Pharma Co, Ltd., Eli Lilly, Gilead Sciences, Janssen Research & Development, LLC., JIMRO, Kissei Pharmaceutical Co, Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Pfizer Inc., and Takeda Pharmaceutical Co., Ltd.
Remo Panaccione reports potential conflicts of interest with Abbivax, Abbott, AbbVie, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Fresenius Kabi, Galapagos, Genentech, Gilead Sciences, GlaxoSmithKline, 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, and UCB.