Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most demanding and high-risk endoscopic procedures.
Failures and complications are more common than we realise, they lead to low satisfaction for the patient, high frustration for the endoscopist, higher risks of more instrumentalization in further re-attempts.

Keeping a meticulous updated data logging is fundamental to understand how we perform, what specific factors predict our failures, and identifying areas of improvement, mistakes or learning opportunities.

Aims & Methods

This prospective cohort study was conducted over a 3-year period (September 2020 to January 2024) at a tertiary care centre.
We defined all the adverse events as per ESGE guidelines¹ The 30- mortality was analysed and stratified based on relation to ERCP.
We also identified patients’ factors (Age, sex, frailty, NEWS>4, anticoagulation, antiplatelets, palliative) and technique (First pass cannulation, double wire, precut sphincterotomy, sphincteroplasty). Descriptive statistics, chi-square or t-tests were used to evaluate associations between clinical characteristics and outcomes.

Results

A total of 438 patients underwent ERCP by the single operator during the study period. Procedural success was achieved in 389 cases (88.9%) and in 100% of cases of non-native ampulla. Success rates were lower in malignant cases (80.6%) compared to benign cases (90.05%) with an odds ratio (OR) of 2.21 (CI 1.05–4.63, p = 0.03).
Complications included: Post-ERCP pancreatitis: 12/438 (2.74%) Infections: 4/438 (0.91%) (3 cholangitis, 1 cholecystitis) Perforation: 3/438 (0.68%) and Bleeding: 2/438 (0.45%)
Mortality within 1 month was 17/438 (3.88%) mostly unrelated to the procedure in palliative and frail patients. Procedure-related mortality occurred in 4 cases (0.91%),due to pancreatitis (n=2),perforation (n=1) and sepsis secondary to cholecystitis (n=1).
Of all conscious sedation, only 204 /423 (48.2%) were deemed comfortable. 174/423 (41.1%) had mild discomfort, 32/423 (7.5%) had significant discomfort and 13/423 ( 3.07%) severe or very poor. Female patients demonstrated higher risk of poor tolerance (OR 2.09, CI 1.05–4.18 p = 0.04) but no higher procedural failure.
In difficult cannulation, double-wire succeeded in 19/36(52.8%). When combined with additional techniques after initial failure, success increased to 77.8%. Pre-cut sphincterotomy succeeded only in 13/25( 52%) lower than data published (>75%), thought to be due to learning curve and limited patient tolerance. However, pre-cut helped cannulation in most follow-up ERCPs .
Double wire associated risk of post-ERCP pancreatitis -but exclusively when prophylactic pancreatic duct stent was not placed-OR 3.96 (CI 1.02-15.3) p=0.04. None other AEs were significantly associated with any advanced cannulation techniques.

Conclusion

Overall failure rates and AEs were consistent with published literature. Statistically significant risks of failure included malignant aetiology (OR 2.21) and poor tolerance (OR 2.20). Female sex associated higher intolerance (OR 2.09). Both double-wire and pre-cut sphincterotomy showed failure rates of approximately 50%. Frailty was a significant predictor of 30-day mortality (OR 4.83).

References

1. Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149.
2. Banks PA, BollenTL, Dervenis C et al. Classification of acute pancreatitis– 2012: revision of the Atlanta classification and definitions by international consensus. Gut 2013; 62: 102–111
3. Enochsson L., Swahn F., Arnelo U., Nilsson M., Löhr M., Persson G. Nationwide, population-based data from 11,074 ERCP procedures from the Swedish Registry for Gallstone Surgery and ERCP. Gastrointest. Endosc. 2010;72:1175–1184.
4. Spadaccini M, Binda C, Fugazza A, Repici A, Tarantino I, Fabbri C, Cugia L, Anderloni A, On Behalf Of The Interventional Endoscopy Amp Ultra Sound I-Eus Group. Informed Consent for Endoscopic Biliary Drainage: Time for a New Paradigm. Medicina (Kaunas). 2022 Feb 22;58(3):331.
5.Chen J, Wan JH, Wu DY, Shu WQ, Xia L, Lu NH. Assessing Quality of Precut Sphincterotomy in Patients With Difficult Biliary Access: An Updated Meta-analysis of Randomized Controlled Trials. J Clin Gastroenterol. 2018 Aug;52(7):573-578

Introduction

The risk of colorectal advanced adenomas (CAAs) and colorectal cancer (CRC) in siblings aged ≤ 50 years of patients diagnosed with early-onset CAAs (E-CAAs), defined as having CAA at or below the age of 50 years​, is poorly understood.

Aims & Methods

This study aimed to compare the risks of adenomas, CAA, and CRC in siblings aged ≤ 50 years of patients diagnosed with E-CAA to those in individuals aged ≤ 50 without such a family history.
This case-control study was conducted at a tertiary hospital in Vietnam. The participants included 96 cases who were siblings aged ≤ 50 years of patients diagnosed with E-CAA. Controls were randomly selected from consecutive patients aged ≤ 50 years who did not have siblings diagnosed with E-CAA. The absence of a family history of CAA in the control group was confirmed through comprehensive history taking. ​The controls were matched to cases in a 2:1 ratio for age (±3 years), sex, and smoking status. Individuals with alarming features of CRC or a family history of CRC were excluded. All the participants underwent standard bowel preparation and colonoscopy.

Results

The mean age was similar between cases (40.9 ± 6.0 years) and controls (41.1 ± 6.0 years). Except for the indications for colonoscopy, there were no significant differences in the baseline demographics between the two groups. A higher risk of CAA was documented in cases compared with controls (odds ratio [OR] = 6.33; 95% confidence interval [CI], 1.43–43.8; P = 0.018). This increased risk of CAA was more pronounced among male participants (OR = 13.7; 95% CI, 1.23–262; P = 0.006). Higher risks of colorectal adenomas (OR = 2.43; 95% CI, 1.27–4.67; P = 0.009) and colorectal neoplasia (OR = 2.23; 95% CI, 1.24–4.40; P = 0.011) were also found in cases compared with controls. CRC was found in one case and two controls.

Conclusion

Siblings aged ≤ 50 years of patients diagnosed with E-CAA have an increased risk of adenomas, CAA, and colorectal neoplasia. CRC screening should be initiated early in high-risk individuals.

Table 1. Risk of Colorectal Neoplasia among Siblings of Patients Diagnosed with Advanced Adenomas (n = 288)

References

Ng SC, Lau JY, Chan FK, et al. Risk of Advanced Adenomas in Siblings of Individuals With Advanced Adenomas: A Cross-Sectional Study. Gastroenterology. 2016;150(3):608-e17.
Cottet V, Pariente A, Nalet B, et al. Colonoscopic screening of first-degree relatives of patients with large adenomas: increased risk of colorectal tumors. Gastroenterology. 2007;133(4):1086-1092.

Introduction

Ulcerative colitis (UC) is a chronic inflammatory disorder characterized by periods of relapse and remission. Current treatment options aim to achieve mucosal healing and sustain long-term remission, yet many patients experience treatment failure. Filgotinib (FIL), a selective JAK1 inhibitor, has emerged as a promising therapeutic agent in UC management with favorable outcomes in clinical trials. This study aimed to evaluate the real-world efficacy and safety of FIL in patients with moderate-to-severe UC.

Aims & Methods

We conducted a multicenter, observational, retrospective study involving adult patients with moderate-to-severe UC who were treated with FIL within the ENEIDA registry, a nationwide prospectively-maintained database. Data were collected from 32 Spanish IBD units between 12/2021 and 10/2024. Patients were eligible if they had an established diagnosis of UC, had been initiated on FIL and without previous colectomy. The primary outcome was clinical remission (defined as partial Mayo ≤2 with no subscore >1 and no rectal bleeding) at week 12 and 52, along with its safety profile.

Results

A total of 100 patients were included (mean age of 38.1 years (SD 18), 58% male, and a median disease duration of 98 months [IQR, 37-166], 61% non-smokers, 18% extraintestinal manifestations). Most of them had extensive (51%) or left-sided colitis (40%). Prior exposure to anti-TNF was present in 81%, vedolizumab in 42%, and ustekinumab in 34%, with 18% also exposed to JAK inhibitors; including 27% exposed to >2 mechanisms. The majority of patients had Mayo 2 or 3 endoscopic score at baseline (88%). All but 2 patients started FIL 200 mg bid (98%) and 30% received concomitant steroids or immunosuppressants (4%).
Steroid-free clinical remission was 43% and 32% after 12 and 52 weeks, respectively. FIL persistence was 62% with median treatment duration of 7 months (IQR, 4-11). Among those previously exposed to JAK inhibitors, persistence was 83% and 39% after 12 and 52 weeks, respectively. This subgroup showed steroid-free clinical remission rates of 33% and 14%, respectively. Overall, hospital admission was indicated in 6% and colectomy in 1%.
FIL was generally well-tolerated, with 17% of patients reporting at least one adverse event, 18% of them considered as serious, including herpes zoster infection in 2% (both vaccinated, 1 severe infection requiring FIL withdrawal), with no cardiovascular or thromboembolic events reported.

Conclusion

In this real-world, multicenter observational study, FIL demonstrated its efficacy in the induction and maintenance of clinical remission in patients with active UC. The real-world safety profile was consistent with previous data, with no unexpected adverse events. These findings support FIL as a valuable therapeutic option in the management of UC.

Disclosure

IRL has received financial support for traveling and educational activities from or has served as an advisory board member for Abbvie, Adacyte, Alfasigma, Biogen, Chiesi, Faes Farma, Ferring, Fresenius Kabi, Galapagos, Johnson & Johnson, Eli Lilly, Mirum Pharmaceuticals, Merck, Pfizer, Roche, Takeda, and Tillotts Pharma. Research support from AbbVie. IRL is supported by a research grant from Gobierno Vasco-Eusko Jaurlaritza [Grant No 2020111061 and 2023222006].

Introduction

We conducted a retrospective analysis of a large U.S. based administrative claims database comparing the risk of major adverse cardiovascular events (MACE) and venous thromboembolism (VTE) among patients with inflammatory bowel disease (IBD) initiating advanced biological therapies.

Aims & Methods

Patients with CD and UC who were incident users of advanced biological agents from 2013 to 2023 were identified within the Optum Labs® database. The therapeutic agents included either tumor necrosis factor-α (TNF) antagonists (infliximab, adalimumab, and certolizumab pegol), IL-12/23 antagonists (ustekinumab), IL-23 antagonists (risankizumab), anti-integrin agents (vedolizumab), Janus kinase (JAK) inhibitors (tofacitinib and upadacitinib), or S1PR modulators (ozanimod). Eligible patients were required to have continuous insurance coverage for at least one year before and after treatment initiation. We estimated incidence rates (IRs) and compared risks for VTE and MACE (myocardial infarction and stroke). Fatal cardiovascular outcomes were excluded due to limited specificity and data constraints.
To account for baseline confounding, we applied stabilized inverse probability of treatment weighting (IPTW) using multinomial propensity scores. Hazard ratios were estimated using Cox proportional hazard models.

Results

We included 12,245 patients with CD (mean age: 44.5 ± 17.5 years; 54.2% female; 30.9% using concomitant steroids), and 9,430 patients with UC (mean age: 47.5 ± 17.7 years; 49.2% female; 50% on concomitant corticosteroids). Patients receiving JAK inhibitors and vedolizumab were more likely to have higher comorbidity burden than others for CD while those receiving IL-23 antagonists had the most comorbid burden for UC patients, when assessed through proportion of patients with Charlson comorbidity index of ≥ 5. In UC patients, VTE incidence rates ranged from 1.69 to 2.01 for VTE and MACE rates from 0.52 to 0.99 per 100 person-years. For CD, VTE incidence rates ranged from 0.89 to 2.33 and for MACE, 0.68 to 1.73. Hazard ratios comparing the risk of events across therapies is presented in table 1.

Table 1: Hazard ratios for risk of VTE and MACE in patients with Crohn’s disease and Ulcerative colitis receiving advanced biological therapies and small molecules

Conclusion

In this large real-world IBD cohort, there was no difference in risk of adverse cardiovascular and thrombotic events between any biological agent or small molecule, in compairosn to TNF antagnoists.

Disclosure

• CM: Consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma Inc, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Forte Biosciences, Fresenius Kabi, Gilead, Janssen, McKesson, Mirador Therapeutics, Mylan, Pendopharm, Pfizer, Prometheus Biosciences Inc., Roche, Sanofi, Takeda, Tillotts Pharma; speaker's fees from AbbVie, Amgen, AVIR Pharma Inc, Alimentiv, Bristol Myers Squibb, Eli Lilly, Ferring, Fresenius Kabi, Janssen, Merck, Organon, Pendopharm, Pfizer, Sanofi, Takeda, Tillotts Pharma; royalties from Springer Publishing; research support from AbbVie, Eli Lilly, Ferring, Pfizer.
• VJ: Consulting/advisory board fees from AbbVie, Alimentiv Inc, Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Prometheus, Reistone Biopharma, Roche, Sandoz, Second Genome,Takeda, Teva, Topivert, Ventyx, Vividion; speaker’s fees from, Abbvie, Ferring, Galapagos, Janssen Pfizer Shire, Takeda, Fresenius Kabi
• SS: Research grants from Pfizer

Clinical Case Summary

A 64-year-old woman with a prior diagnosis of type I achalasia underwent Heller myotomy with Dor fundoplication in 2015, which resulted in the resolution of dysphagia and regurgitation. However, she kept experiencing chest pain, which partially improved with nitro-glycerine. In 2018, due to worsening pain, she underwent high-resolution oesophageal manometry (HROM), which demonstrated absent peristalsis without oesophageal pressurization. Also, upper endoscopy was unremarkable, and timed barium swallow (TBS) revealed some tertiary contractions. By 2019, the patient received botulinum toxin injections with partial improvement. Another TBS performed in 2023 showed tertiary contractions in the distal third of the oesophagus, contributing to mild oesophageal emptying delay but without stasis. In 2024, repeat HROM revealed pan-oesophageal pressurization, except in the distal-most centimetres of the oesophagus. During rapid drink challenge, the patient reported pain. Given these findings, she was proposed for peroral endoscopic myotomy (POEM) to extend the myotomy proximally. In August 2024, she underwent a complete distal oesophageal myotomy, including the lower oesophageal sphincter and cardia. Endoscopic assessment in November showed no evidence of stasis, esophagitis, or resistance at the cardia. Latest clinical evaluation in March 2025 confirmed complete resolution of chest pain.
Conclusion: Non-cardiac chest pain is a less common yet challenging symptom to manage in achalasia. Its persistence after disease-directed treatment has been described in the literature, with its primary risk factor being its presence preoperatively¹. However, comparative data on different therapeutic approaches for achalasia-related chest pain remain limited. To our knowledge, only two similar cases have been reported in which pain persisted after Heller myotomy but improved following POEM, probably linked to the inadequate or incomplete myotomy of the oesophageal muscle layer^2,3.

References

1. Olvera-Prado H, et al. Predictive factors associated with the persistence of chest pain in post-laparoscopic myotomy and fundoplication in patients with achalasia. Front Med (Lausanne). 2022 Oct 14;9:941581.
2. Miftahussurur M, Tandan M, Makmun D, Nabi Z. Peroral Endoscopic Myotomy in a Patient with Achalasia Cardia with Prior Heller's Myotomy. Case Rep Gastroenterol. 2020 Jan 22;14(1):48-55.
3. Sato C, et al. Salvage therapy for postoperative residual chest pain due to esophageal achalasia. SAGES 2017 Annual Meeting in Houston [Abstract], https://www.sages.org/meetings/annual-meeting/abstracts-archive/salvage-therapy-for-postoperative-residual-chest-pain-due-to-esophageal-achalasia/