Endoscopic Vacuum Therapy for Upper Gastrointestinal Leaks and Perforations: Analysis From a Multicenter Spanish Registry.

INTRODUCTION: Endoscopic vacuum therapy (EVT) is a novel technique for closing upper gastrointestinal (UGI) defects. Available literature includes single-center retrospective cohort studies with small sample sizes. Furthermore, evidence about factors associated with EVT failure is scarce. We aimed to assess the efficacy and safety of EVT for the resolution of UGI defects in a multicenter study and to investigate the factors associated with EVT failure and in-hospital mortality. METHODS: This is a prospective cohort study in which consecutive EVT procedures for the treatment of UGI defects from 19 Spanish hospitals were recorded in the national registry between November 2018 and March 2022. RESULTS: We included 102 patients: 89 with anastomotic leaks and 13 with perforations. Closure of the defect was achieved in 84 cases (82%). A total of 6 patients (5.9%) had adverse events related to the EVT. The in-hospital mortality rate was 12.7%. A total of 6 patients (5.9%) died because of EVT failure and 1 case (0.9%) due to a fatal adverse event. Time from diagnosis of the defect to initiation of EVT was the only independent predictor for EVT failure (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05, P = 0.005). EVT failure (OR 24.5, 95% CI 4.5-133, P = 0.001) and development of pneumonia after EVT (OR 246.97, 95% CI 11.15-5,472.58, P = 0.0001) were independent predictors of in-hospital mortality. DISCUSSION: EVT is safe and effective in cases of anastomotic leak and perforations of the upper digestive tract. The early use of EVT improves the efficacy of this technique.

Pancreatic Cancer Surveillance in Carriers of a Germline Pathogenic Variant in CDKN2A.

Three percent of patients with pancreatic ductal adenocarcinoma (PDAC) present a germline pathogenic variant (GPV) associated with an increased risk of this tumor, CDKN2A being one of the genes associated with the highest risk. There is no clear consensus on the recommendations for surveillance in CDKN2A GPV carriers, although the latest guidelines from the International Cancer of the Pancreas Screening Consortium recommend annual endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) regardless of family history. Our aim is to describe the findings of the PDAC surveillance program in a cohort of healthy CDKN2A GPV heterozygotes. This is an observational analysis of prospectively collected data from all CDKN2A carriers who underwent screening for PDAC at the high-risk digestive cancer clinic of the "Hospital Clínic de Barcelona" between 2013 and 2021. A total of 78 subjects were included. EUS or MRI was performed annually with a median follow-up of 66 months. Up to 17 pancreatic findings were described in 16 (20.5%) individuals under surveillance, although most of them were benign. No significant precursor lesions were identified, but an early PDAC was detected and treated. While better preventive strategies are developed, we believe that annual surveillance with EUS and/or MRI in CDKN2A GPV heterozygotes may be beneficial.

Motorized Spiral Enteroscopy Is Effective in Patients with Prior Abdominal Surgery.

BACKGROUND: Motorized Spiral Enteroscopy (MSE) reduces procedure time and increases insertion depth into the small bowel; however, there is scarce evidence on factors affecting MSE efficacy. AIMS: To evaluate diagnostic yield and adverse events of MSE including patients with prior major abdominal surgery. METHODS: A prospective observational study was conducted on patients undergoing MSE from June 2019 to December 2021. Demographic characteristics, procedure time, depth of maximum insertion (DMI), technical success, diagnostic yield, and adverse events were collected. RESULTS: Seventy-four anterograde (54.4%) and 62 retrograde (45.6%) enteroscopies were performed in 117 patients (64 males, median age 67 years). Fifty patients (42.7%) had prior major abdominal surgery. Technical success was 91.9% for anterograde and 90.3% for retrograde route. Diagnostic yield was 71.6% and 61.3%, respectively. The median DMI was 415 cm (264-585) for anterograde and 120 cm (37-225) for retrograde enteroscopy. In patients with prior major abdominal surgery, MSE showed significantly longer small bowel insertion time (38 vs 29 min, p = 0.004), with similar diagnostic yield (61 vs 71.4%, p = 0.201) and DMI (315 vs 204 cm, p = 0.226). The overall adverse event rate was 10.3% (SAE 1.5%), with no differences related to prior abdominal surgery (p = 0.598). Patients with prior surgeries directly involving the gastrointestinal tract showed lower DMI (189 vs 374 cm, p = 0.019) with equal exploration time (37.5 vs 38 min, p = 0.642) compared to those with other abdominal surgeries. CONCLUSIONS: MSE is effective and safe in patients with major abdominal surgery, although longer procedure times were observed. A lower depth of insertion was detected in patients with gastrointestinal surgery.

Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial.

BACKGROUND : It is unknown whether there is an advantage to using the wet-suction or slow-pull technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) with new-generation needles. We aimed to compare the performance of each technique in EUS-FNB. METHODS: This was a multicenter, randomized, single-blind, crossover trial including patients with solid lesions of ≥ 1 cm. Four needle passes with 22 G fork-tip or Franseen-type needles were performed, alternating the wet-suction and slow-pull techniques in a randomized order. The primary outcome was the histological yield (samples containing an intact piece of tissue of at least 550 µm). Secondary end points were sample quality (tissue integrity and blood contamination), diagnostic accuracy, and adequate tumor fraction. RESULTS: Overall, 210 patients with 146 pancreatic and 64 nonpancreatic lesions were analyzed. A tissue core was retrieved in 150 (71.4 %) and 129 (61.4 %) cases using the wet-suction and the slow-pull techniques, respectively (P = 0.03). The mean tissue integrity score was higher using wet suction (P = 0.02), as was the blood contamination of samples (P < 0.001). In the two subgroups of pancreatic and nonpancreatic lesions, tissue core rate and tissue integrity score were not statistically different using the two techniques, but blood contamination was higher with wet suction. Diagnostic accuracy and tumor fraction did not differ between the two techniques. CONCLUSION: Overall, the wet-suction technique in EUS-FNB resulted in a higher tissue core procurement rate compared with the slow-pull method. Diagnostic accuracy and the rate of samples with adequate tumor fraction were similar between the two techniques.

The presence and outcome of biliary sphincter disorders in liver-transplant recipients according to the Rome IV classification.

BACKGROUND: Biliary sphincter disorders after liver transplantation (LT) are poorly described. We aim to describe the presence and outcome of patients with papillary stenosis (PS) and functional biliary sphincter disorders (FBSDs) after LT according to the updated Rome IV criteria. METHODS: We reviewed all endoscopic retrograde cholangiopancreatographies (ERCPs) performed in LT recipients between January 2003 and December 2019. Information on clinical and endoscopic findings was obtained from electronic health records and endoscopy databases. Laboratory and clinical findings were collected at the time of ERCP and 1 month after ERCP. RESULTS: Among the 1,307 LT recipients, 336 underwent 849 ERCPs. Thirteen (1.0%) patients met the updated Rome IV criteria for PS [former sphincter of Oddi dysfunction (SOD) type I] and 14 patients (1.0%) met the Rome IV criteria for FBSD (former SOD type II). Biliary sphincterotomy was performed in 13 PS and 10 FBSD cases. One month after sphincterotomy, bilirubin, gamma-glutamyl transferase and alkaline phosphatase levels decreased in 85%, 61%, and 92% of those in the PS group (P = 0.019, 0.087, and 0.003, respectively) and in 50%, 70%, and 80% of those in the FBSD group (P = 0.721, 0.013, and 0.093, respectively). All the 14 patients initially suspected of having a FBSD turned out to have a different diagnosis during the follow-up. CONCLUSIONS: PS after LT is uncommon and occurs in only 1% of LT recipients. Our data do not support the presence of an FBSD after LT. Sphincterotomy is a safe and effective procedure in LT recipients with PS.

Performance of a new flexible 19 G EUS needle in pancreatic solid lesions located in the head and uncinate process: A prospective multicenter study.

Background and study aims The poor flexibility of large-bore EUS needles often leads to technical failure when sampling from the duodenum. The aim of this study was to evaluate the technical and diagnostic performances of a new Menghini tip 19G nitinol EUS needle for sampling pancreatic solid lesions in the head and uncinate process. Patients and methods This was a European prospective multicenter single-arm study. A maximum of four passes were allowed. In case of failure, different needles were permitted. Results We included 75 patients (51 % males) with lesions in the head (n = 68; 91 %) and uncinate process (n = 7; 9 %) (mean size: 33 ±â€Š12 mm; number of passes: 1.8 ±â€Š0.9). Technical success was seen in 71 of 75 (94.7 %). Diagnostic rates were 89.3 % (67/75) and 94.4 % (67/71) in the intention-to-treat (ITT) and per-protocol (PP) analysis, respectively. In the eight cases with failure, diagnosis was obtained with another needle (n = 4), from another lesion (n = 3) or with follow-up (n = 1). A histological sample was obtained in 64 patients (ITT 85.3 % and PP 90 %) and immunohistochemistry was successfully performed in 13 of 15 lesions in which it was required. No differences between rapid on-site evaluation (ROSE) and non-ROSE groups were observed regarding diagnostic success (87.5 % vs 91 %, P  = 0.582) and diagnosis at the first pass (70 % vs 81 %, P  = 0.289). Number of passes was lower in the ROSE group (1.4 + 0.9 vs 2.2 + 0.7, P  < 0.001). One adverse event was recorded (1.3 %) consisting in a duodenal perforation after a single session EUS-ERCP. Conclusions The new nitinol Menghini tip 19G EUS needle showed high technical diagnostic success in safely sampling solid lesions in the head and uncinate process of the pancreas.

Endoscopic Ultrasound-guided Fine-needle Biopsy With or Without Rapid On-site Evaluation for Diagnosis of Solid Pancreatic Lesions: A Randomized Controlled Non-Inferiority Trial.

BACKGROUND AND AIMS: The benefit of rapid on-site evaluation (ROSE) on the diagnostic accuracy of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) has never been evaluated in a randomized study. This trial aimed to test the hypothesis that in solid pancreatic lesions (SPLs), diagnostic accuracy of EUS-FNB without ROSE was not inferior to that of EUS-FNB with ROSE. METHODS: A noninferiority study (noninferiority margin, 5%) was conducted at 14 centers in 8 countries. Patients with SPLs requiring tissue sampling were randomly assigned (1:1) to undergo EUS-FNB with or without ROSE using new-generation FNB needles. The touch-imprint cytology technique was used to perform ROSE. The primary endpoint was diagnostic accuracy, and secondary endpoints were safety, tissue core procurement, specimen quality, and sampling procedural time. RESULTS: Eight hundred patients were randomized over an 18-month period, and 771 were analyzed (385 with ROSE and 386 without). Comparable diagnostic accuracies were obtained in both arms (96.4% with ROSE and 97.4% without ROSE, P = .396). Noninferiority of EUS-FNB without ROSE was confirmed with an absolute risk difference of 1.0% (1-sided 90% confidence interval, -1.1% to 3.1%; noninferiority P < .001). Safety and sample quality of histologic specimens were similar in both groups. A significantly higher tissue core rate was obtained by EUS-FNB without ROSE (70.7% vs. 78.0%, P = .021), with a significantly shorter mean sampling procedural time (17.9 ± 8.8 vs 11.7 ± 6.0 minutes, P < .0001). CONCLUSIONS: EUS-FNB demonstrated high diagnostic accuracy in evaluating SPLs independently on execution of ROSE. When new-generation FNB needles are used, ROSE should not be routinely recommended. (ClinicalTrial.gov number NCT03322592.).

Evaluación del cumplimiento a largo plazo de los indicadores de calidad en la esofagogastroduodenoscopia / Evaluation of long-term adherence to oesophagogastroduodenoscopy quality indicators

INTRODUCCIÓN: En un estudio previo demostramos que un pequeño programa de formación mejoraba los indicadores de calidad de la esofagogastroduodenoscopia (EGD) que llegaban a los estándares recomendados. Sin embargo, desconocemos el efecto de esta formación a largo plazo. El objetivo de este estudio fue valorar la calidad de las EGD después de 3años de haber realizado un programa de mejora. MATERIAL Y MÉTODOS: Estudio comparativo de 2 cohortes: EGD posteriores a un programa de formación realizado en 2016 (grupo A) y EGD en enero-marzo de 2019 (grupo B). El grupo B se dividió en 2 subgrupos: endoscopistas que habían participado en el programa de formación previo (B1) y los que no (B2). Se utilizaron los indicadores de calidad intraprocedimiento recomendados por la ASGE-ACG. RESULTADOS: Se analizaron un total de 1.236 EGD, 600 en el grupo A y 636 en el B (439 subgrupo B1 y 197 subgrupo B2). El número de exploraciones completas fue inferior en el grupo B (566 [94,3%] vs. 551 [86,6%]; p < 0,001). Se observó una disminución significativa en prácticamente todos los indicadores de calidad que, además, no alcanzaron los estándares recomendados: retroversión gástrica (96% vs. 81%; p < 0,001); protocolo de biopsias de Seattle (86% vs. 50%; p = 0,03), descripción de la lesión en la hemorragia (100% vs. 62%; p < 0,01), toma de ≥4 biopsias en sospecha de celiaquía (92,5% vs. 18%; p < 0,001), fotodocumentación de lesión (94% vs. 90%; p < 0,05). Cuando consideramos el global de la prueba (incluyendo la actuación correcta y la fotodocumentación adecuada), también se observó una disminución significativa (90,5% vs. 62%; p < 0,001). No hubo diferencias entre los subgrupos B1 y B2. CONCLUSIONES: La mejora observada en 2016 tras un programa de formación no perdura a los 3años. Es necesario hacer programas de formación continuados para mantener la calidad de la EGD por encima de los estándares recomendados

INTRODUCTION: In a previous study we demonstrated that a simple training programme improved quality indicators of Oesophagogastroduodenoscopy (OGD) achieving the recommended benchmarks. However, the long-term effect of this intervention is unknown. The aim of this study was to assess the quality of OGDs performed 3 years after of having completed a training programme. MATERIAL AND METHODS: A comparative study of 2 cohorts was designed as follows: Group A included OGDs performed in 2016 promptly after a training programme and Group B with OGDs performed from January to March 2019, this group was also divided into 2 subgroups: subgroup B1 of Endoscopists who had participated in the previous training programme and subgroup B2 of Endoscopists who had not. The intra-procedure quality indicators proposed by ASGE-ACG were used. RESULTS: A total of 1236 OGDs were analysed, 600 from Group A and 636 from Group B (439 subgroup B1 and 197 subgroup B2). The number of complete examinations was lower in Group B (566 [94.3%] vs. 551 [86.6%]; p < 0.001). A significant decrease was observed in nearly all quality indicators and they did not reach the recommended benchmarks: retroflexion in the stomach (96% vs. 81%; p < 0.001); Seattle biopsy protocol (86% vs. 50%; p = 0.03), description of the upper GI bleeding lesion (100% vs. 62%; p < 0.01), sufficient intestinal biopsy specimens (at least 4) in suspected coeliac disease (92.5% vs. 18%; p < 0.001), photo documentation of the lesion (94% vs. 90%; p < 0.05). Regarding the overall assessment of the procedure (including correct performance and adequate photo documentation), a significant decrease was also observed (90.5% vs. 62%; p < 0.001). There were no differences between subgroups B1 and B2. CONCLUSIONS: The improvement observed in 2016 after a training programme did not prevail after 3 years. In order to keep the quality of OGDs above the recommended benchmarks, it is necessary to implement continuous training programmes

Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study.

BACKGROUND: Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions. METHODS: The VICOCA study is a prospective, single-centre, randomised trial conducted from March 2014 to May 2016; 662 individuals were invited and 349 were randomised to CCE or CTC before colonoscopy. Endoscopists were blinded to the results of CCE and CTC. RESULTS: Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group. Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group. In the intention-to-screen analysis, sensitivity, specificity and positive and negative predictive values for the identification of individuals with colorectal neoplasia were 98.1%, 76.6%, 93.7% and 92.0% in the CCE group and 64.9%, 95.7%, 96.8% and 57.7% in the CTC group. In terms of detecting significant neoplastic lesions, the sensitivity of CCE and CTC was 96.1% and 79.3%, respectively. Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p = 0.08). Both CCE and CTC identified all patients with cancer. CCE detected more patients with any lesion than CTC (98.6% and 81.0%, respectively; RR = 1.22; p = 0.002). CONCLUSION: Although both techniques seem to be similar in detecting patients with advanced colorectal neoplasms, CCE is more sensitive for the detection of any neoplastic lesion. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02081742 . Registered: September 16, 2013.

Evaluation of long-term adherence to oesophagogastroduodenoscopy quality indicators. / Evaluación del cumplimiento a largo plazo de los indicadores de calidad en la esofagogastroduodenoscopia.

INTRODUCTION: In a previous study we demonstrated that a simple training programme improved quality indicators of Oesophagogastroduodenoscopy (OGD) achieving the recommended benchmarks. However, the long-term effect of this intervention is unknown. The aim of this study was to assess the quality of OGDs performed 3 years after of having completed a training programme. MATERIAL AND METHODS: A comparative study of 2 cohorts was designed as follows: Group A included OGDs performed in 2016 promptly after a training programme and Group B with OGDs performed from January to March 2019, this group was also divided into 2 subgroups: subgroup B1 of Endoscopists who had participated in the previous training programme and subgroup B2 of Endoscopists who had not. The intra-procedure quality indicators proposed by ASGE-ACG were used. RESULTS: A total of 1236 OGDs were analysed, 600 from Group A and 636 from Group B (439 subgroup B1 and 197 subgroup B2). The number of complete examinations was lower in Group B (566 [94.3%] vs. 551 [86.6%]; p<0.001). A significant decrease was observed in nearly all quality indicators and they did not reach the recommended benchmarks: retroflexion in the stomach (96% vs. 81%; p<0.001); Seattle biopsy protocol (86% vs. 50%; p=0.03), description of the upper GI bleeding lesion (100% vs. 62%; p<0.01), sufficient intestinal biopsy specimens (at least 4) in suspected coeliac disease (92.5% vs. 18%; p<0.001), photo documentation of the lesion (94% vs. 90%; p<0.05). Regarding the overall assessment of the procedure (including correct performance and adequate photo documentation), a significant decrease was also observed (90.5% vs. 62%; p<0.001). There were no differences between subgroups B1 and B2. CONCLUSIONS: The improvement observed in 2016 after a training programme did not prevail after 3 years. In order to keep the quality of OGDs above the recommended benchmarks, it is necessary to implement continuous training programmes.

EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial.

Background and study aims EUS-FNA has suboptimal accuracy in diagnosing gastrointestinal subepithelial tumors (SETs). EUS-guided 22-gauge fine needle biopsy (EUS-FNB) and single-incision with needle knife (SINK) were proposed to increase accuracy of diagnosis. This study aimed to prospectively compare the diagnostic accuracy and safety of EUS-FNB with SINK in patients with upper gastrointestinal SETs. Patients and methods All adult patients referred for EUS evaluation of upper gastrointestinal SETs ≥ 15 mm in size were eligible for inclusion. Patients were randomized to undergo EUS-FNB or SINK. Lesions were sampled with a 22-gauge reverse beveled core needle in the EUS-FNB group and by a conventional needle-knife sphincterotome and biopsy forceps in the SINK group. Patients were blinded to the technique used. The primary outcome was diagnostic accuracy. Secondary outcomes included adverse events, histological yield and procedure duration. Study enrollment was terminated early due to poor recruitment. Results A total of 56 patients (31 male (55.37 %); mean age, 67.41 ±â€Š12.70 years) were randomized to either EUS-FNB (n = 26) or SINK (n = 30). Technical success was 96.15 % and 96.66 %, respectively. The majority of lesions were gastrointestinal stromal tumors (51.78 %). No significant difference was found between EUS-FNB and SINK in terms of diagnostic accuracy for a malignant or benign disease (76 % vs. 89.28 %, respectively; P  = 0.278). The rate of adverse events (none severe) was also comparable (7.69 % vs. 10 %, respectively; P =  1.0) including two abdominal pain episodes in the EUS-FNB group compared to two delayed bleeding (one requiring hospitalization and radiologic embolization) and 1 abdominal pain in the SINK group. Conclusion EUS-FNB and SINK are equally effective techniques for upper gastrointestinal SETs sampling. SINK can be associated with mild to moderate delayed bleeding.

Antibiotic Prophylaxis Is Not Required for Endoscopic Ultrasonography-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions, Based on a Randomized Trial.

BACKGROUND & AIMS: Guidelines recommend routine antibiotic prophylaxis for patients undergoing endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic cysts, but there is conflicting evidence for its necessity. We investigated whether performing the procedure without antimicrobial prophylaxis increases the incidence of infection. METHODS: We performed a multicenter, randomized, noninferiority trial to compare prophylaxis with ciprofloxacin vs placebo in patients with a pancreatic cyst requiring EUS-FNA at multiple centers in Spain. From September 2014 to June 2018, patients were randomly assigned to groups that received the prophylaxis with ciprofloxacin (n = 112) or saline solution (n = 114, placebo). We recorded patients' demographic data, lesion characteristics, and procedure data and followed patients for 21 days. A total of 205 patients completed the trial (90.7%), receiving ciprofloxacin or the control, with no statistically significant differences in demographics, baseline data, or procedure characteristics between groups. The primary outcome was FNA-related infection. Secondary outcomes were incidence of fever, procedure complications, and medication-related adverse events. RESULTS: The only case of FNA-related infection (0.44%) occurred in a patient in the placebo group (0.87%); this patient developed acute pancreatitis and bacteremia after the procedure. Prevention of infection was not inferior in the control group; the difference between proportions was 0.87% (95% confidence interval, -0.84% to 2.59%). There were no differences between groups in fever (2 patients in each group: 1.78% vs 1.76%; P = 1.00) or other adverse events. CONCLUSIONS: In a randomized trial of patients undergoing EUS-FNA for pancreatic cyst evaluation, we found the risk of infection to be low. The incidence of infections did not differ significantly with vs without ciprofloxacin prophylaxis. (ClinicalTrials.gov, Number: NCT02261896).

Adverse Events and Acute Chronic Liver Failure in Patients With Cirrhosis Undergoing Endoscopic Retrograde Cholangiopancreatography: A Multicenter Matched-Cohort Study.

BACKGROUND: Data on the outcome of adverse events (AEs) and the risk of developing acute-on-chronic liver failure (ACLF) after ERCP in patients with cirrhosis are unknown. We examined the incidence and risk factors of post-ERCP AEs in patients with cirrhosis and the appearance of ACLF after ERCP. METHODS: In this multicenter, retrospective, matched-cohort study, we evaluated ERCPs performed from January 2002 to 2015. A group of patients with cirrhosis with non-ERCP interventions and one without interventions was also analyzed for the development of ACLF. RESULTS: A total of 441 ERCPs were analyzed; 158 in patients with cirrhosis (cases) and 283 in patients without cirrhosis (controls). The overall rate of AEs after all ERCPs was significantly higher in cases compared to controls (17% vs 9.5, p = 0.02). Cholangitis developed more in cases compared to controls (6.3% vs 1.8%; p = 0.01). In a subanalysis of those with sphincterotomy, the rate of bleeding was higher in those with cirrhosis (9.4% vs 3.4%; p = 0.03). Logistic regression identified cirrhosis (OR, 2.48; 95% CI, 1.36-4.53; p = 0.003) and sphincterotomy (OR, 2.66; 95% CI, 1.23-5.72; p = 0.01) as risk factors of AEs. A total of 18/158 (11.4%) cases developed ACLF after ERCP. ACLF occurred in 7/27 cases with post-ERCP AEs and in 11/131 without post-ERCP AEs (25.9% vs 8.3%; p = 0.01). A total of 3.2% (13/406) patients without interventions developed ACLF compared to 17.5% (102/580) who developed ACLF after non-ERCP interventions. Patients with decompensated cirrhosis at ERCP had a higher risk of developing ACLF (17% vs 6.8%; p = 0.04). Patients with a MELD score ≥ 15 were 3.1 times more likely (95% CI: 1.14-8.6; p = 0.027) to develop ACLF after ERCP. CONCLUSIONS: The rate of AEs after ERCP is higher in patients with cirrhosis compared to the non-cirrhotic population. The incidence of ACLF is higher in those with AEs after ERCP compared to those without AEs, especially cholangitis. The development of ACLF is common after ERCP and other invasive procedures. ACLF can be precipitated by numerous factors which include preceding events before the procedure, including manipulation of the bile duct, and AEs after an ERCP.