Endoscopic retrograde cholangiopancreatography (ERCP) remains the cornerstone in the diagnosis and management of a wide spectrum of biliary and pancreatic disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstruction, and postoperative bile leaks. Initially developed as a diagnostic tool in the 1960s, ERCP has evolved into a predominantly therapeutic procedure with the advent of magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS) for non-invasive imaging (1, 2). Despite these advances, ERCP carries a risk of procedure-related complications such as post-ERCP pancreatitis (PEP), bleeding, perforation, cholangitis, and rarely, procedure-related mortality (3, 4). The overall incidence of ERCP-related complications in large Western series ranges from 5% to 10%, and mortality rates are generally <0.5% (3, 5, 6). Post-ERCP pancreatitis (PEP) is the most common and clinically significant complication, with reported incidences varying between 2% and 10% in general populations and up to 30% in high-risk cases (5,7). It accounts for significant post-procedural morbidity, prolonged hospital stay, and increased healthcare costs. Other adverse events such as bleeding (0.3–2%), perforation (0.1–0.6%), and cholangitis (1–3%) occur less frequently but can be life-threatening when unrecognized (8,9). Several patient-related (younger age, suspected sphincter of Oddi dysfunction, prior pancreatitis) and procedure-related factors (difficult cannulation, pancreatic duct injection, precut sphincterotomy, prolonged duration, and trainee involvement) have been implicated as predictors of complications (3,10,11). Prophylactic measures—such as rectal NSAIDs, aggressive periprocedural hydration, and pancreatic duct stenting—have proven effective in reducing the incidence of PEP in high-risk individuals (5,12,13). However, adherence to these preventive strategies varies widely in real-world settings, particularly in low- and middle-income countries, where resource constraints and variable expertise may influence outcomes. From the Indian perspective, there is a relative paucity of large-scale prospective or retrospective studies analyzing ERCP-related complications in tertiary centers. The majority of available Indian data are single-center studies with smaller sample sizes (10–14). Dahale et al. (11) reported a 3.3% overall complication rate in a large series from Western India, while Tiwari et al. (10) and Ramchandani et al. (12) observed complication rates around 6–9% in North and South Indian cohorts, respectively. Such variations highlight the influence of procedural techniques, patient profiles, and operator experience across centers. Moreover, differences in disease patterns—such as the high prevalence of gallstone disease, biliary parasitosis, and gallbladder carcinoma in Northern India—necessitate region-specific data (14–16). A comprehensive analysis from high-volume centers is therefore essential to benchmark performance, identify risk factors, and refine preventive strategies tailored to Indian practice. The present study aims to provide a three-year retrospective audit of 1000 ERCP procedures performed at a tertiary care center in North India, with the objectives of assessing the incidence, identifying risk factors, and evaluating the short-term outcomes of ERCP-related complications.

Study Design and Setting: Retrospective observational study conducted at Apex Hospitals, Jaipur- a tertiary referral center performing >300 ERCPs annually by experienced endoscopists. Study Period: January 2022 – December 2024 (36 months). Inclusion Criteria • All consecutive ERCPs (diagnostic or therapeutic) performed during the study period. • Complete documentation of procedure and post-procedure outcomes. Exclusion Criteria • Incomplete records or loss to follow-up within 72 hours. • Repeat ERCPs within the same hospitalization (only the index procedure included). Data Collection: Clinical and procedural data were extracted from ERCP registers and electronic medical records. Variables recorded: • Demographics: age, sex, comorbidities (diabetes, CKD, cirrhosis). • Indications: CBD stones, benign or malignant strictures, bile leaks, PSC, pancreatic diseases. • Procedural factors: • Type of ERCP (diagnostic / therapeutic). • Cannulation difficulty (standard vs difficult). • Precut sphincterotomy. • Pancreatic duct cannulation or contrast injection. • Stent type (plastic vs SEMS). • Procedure duration. • Operator experience (consultant / trainee). Complications: PEP, bleeding, perforation, cholangitis, mortality. Severity grading: as per Cotton and ASGE criteria. Definitions • PEP: new abdominal pain with amylase ≥ 3× ULN at 24 h, requiring hospitalization ≥ 2 days. • Bleeding: melena or hematemesis, hemoglobin drop ≥ 2 g/dL, or need for intervention. • Perforation: extraluminal leak or free air attributable to procedure. • Cholangitis: fever > 38 °C with elevated bilirubin/alkaline phosphatase within 48 h post-ERCP. • Mortality: death within 30 days directly due to ERCP complication. Statistical Analysis • Descriptive statistics summarized baseline features. • Categorical data: Chi-square / Fisher’s exact test. • Continuous data: t-test / Mann–Whitney U. • Variables with p < 0.10 in univariate analysis entered into multivariate logistic regression to identify independent predictors of complications. • p < 0.05 considered statistically significant. • SPSS v26 used for all analyses. • Ethics: Approved by Institutional Ethics Committee, Apex Hospitals. Data anonymized.

Table 1. Baseline Demographic and Clinical Characteristics (n = 1000) Variable Mean ± SD / n (%) Age (years) 54.8 ± 13.7 Male : Female 540 : 460 (1.1 : 1) Diabetes mellitus 210 (21.0 %) Chronic kidney disease 50 (5.0 %) Cirrhosis / CLD 70 (7.0 %) Previous pancreatitis 35 (3.5 %) ASA grade ≥ III 82 (8.2 %) In-hospital stay (days, median [IQR]) 2 [1 – 3] Table 2. Indications for ERCP Indication n % of total CBD stones / choledocholithiasis 450 45.0 Benign biliary stricture 150 15.0 Malignant biliary stricture 220 22.0 Bile leak / post-cholecystectomy 40 4.0 Pancreatic duct disorders 50 5.0 Primary sclerosing cholangitis / others 90 9.0 Total 1000 100.0 Table 3. Procedural Characteristics Variable n (%) Therapeutic ERCPs 870 (87 %) Diagnostic ERCPs 130 (13 %) Difficult cannulation 210 (21 %) Pre-cut sphincterotomy 60 (6 %) Pancreatic duct contrast injection 90 (9 %) Procedure duration > 45 min 310 (31 %) Plastic stent placed 180 (18 %) SEMS placed 160 (16 %) Multiple stents 50 (5 %) Trainee involvement 300 (30 %) Table 4. Incidence and Spectrum of ERCP-Related Complications Complication n % Any complication 74 7.4 Post-ERCP pancreatitis 42 4.2 Bleeding 19 1.9 Perforation 5 0.5 Cholangitis / sepsis 8 0.8 Procedure-related mortality 2 0.2 Table 5. Severity and Management of Major Complications Type Mild n (%) Moderate n (%) Severe n (%) Conservative Endoscopic/Radiologic Surgical Mortality Post-ERCP pancreatitis 30 (71.4) 9 (21.4) 3 (7.1) 36 6 0 0 Bleeding 10 (52.6) 4 (21.1) 5 (26.3) 14 5 0 0 Perforation 2 (40.0) 1 (20.0) 2 (40.0) 3 0 2 1 Cholangitis 7 (87.5) 1 (12.5) 0 8 0 0 0 Total - - - 61 (82 %) 11 (15 %) 2 (3 %) 2 (0.2 %) Table 6. Univariate Analysis of Predictors of Any Complication Variable Complications (%) No Complications (%) p value Difficult cannulation 17.6 5.2 0.004 Pre-cut sphincterotomy 12.3 6.8 0.02 Pancreatic duct injection 19.8 6.4 0.001 Procedure > 45 min 12.1 5.9 0.03 Trainee involvement 9.4 6.5 0.04 Age > 60 years 6.9 7.6 NS Diabetes 8.1 7.3 NS Table 7. Multivariate Logistic Regression for Independent Predictors of ERCP Complications Variable Odds Ratio (95 % CI) p value Difficult cannulation 3.1 (1.7 – 5.8) 0.001 Pancreatic duct injection 2.8 (1.4 – 5.3) 0.002 Pre-cut sphincterotomy 2.2 (1.1 – 4.5) 0.03 Procedure duration > 45 min 1.9 (1.0 – 3.4) 0.04 Trainee operator 1.6 (0.9 – 3.0) 0.07 Most PEP cases were mild (71 %), 9 % severe. Bleeding managed conservatively in 14 cases; 5 needed endoscopic therapy. Two perforations required surgery. Median hospital stay increased from 2 to 7 days in those with complications (p < 0.001).

This three-year retrospective audit from a tertiary center in North India provides a comprehensive overview of ERCP-related complications in over 1000 consecutive procedures. The overall complication rate (7.4%) observed in our cohort aligns closely with both global and Indian literature, reinforcing the safety and effectiveness of ERCP when performed by experienced operators under standardized protocols (1–3). Incidence Compared with Global and Indian Data Internationally, the reported overall complication rates of ERCP range between 5–10%, with mortality rates below 0.5% (4,5). Large prospective series such as those by Freeman et al. (4) and Andriulli et al. (6) documented overall complication rates of 9.8% and 6.8%, respectively. Our findings are in line with these figures and consistent with modern benchmarks suggested by the ASGE and ESGE (2,3,7). In India, multicentric and single-center studies have demonstrated a similar trend. Tiwari et al. (10) reported 9.2% complications in a North Indian tertiary hospital, while Dahale et al. (11) found an overall rate of 3.3% in a large Mumbai cohort of 17,163 ERCPs. Ramchandani et al. (12) from Hyderabad observed 6.2% complications, predominantly mild PEP. A JGH Ope n study by Singh et al. (14) reported a 7.8% rate, mirroring our present data. These comparable outcomes suggest that ERCP safety standards in Indian centers are now at par with international practices. Post-ERCP Pancreatitis Post-ERCP pancreatitis (PEP) remains the most common adverse event. The 4.2% incidence in our series matches prior Indian and Western data (5, 9,10,12,13). Dumonceau et al. (3) summarized global PEP incidence between 2% and 10%, and Freeman’s landmark multicentric trial (4) found 5.4%. Indian studies by Giri et al. (15) and Ramchandani et al. (12) similarly reported rates of 4–6%. PEP arises from mechanical, hydrostatic, or chemical injury to the pancreatic duct epithelium due to repeated cannulation attempts or contrast injection (4,6,8). Recognized risk factors include younger age, female sex, prior pancreatitis, difficult cannulation, precut sphincterotomy, pancreatic duct injection, and prolonged procedure time (5,7,8,16,17). In our analysis, difficult cannulation and pancreatic duct injection were the most significant independent predictors. Both findings are consistent with large Western cohorts (4,6,16,17) and Indian series (10–12). Bleeding and Perforation Our bleeding incidence of 1.9% parallels global figures (0.3–2%) (8,9,16). Most cases were self-limited or endoscopically managed, emphasizing the effectiveness of prompt recognition and hemostasis techniques (18,19). Perforation occurred in 0.5%, consistent with earlier reports (0.3–0.6%) (20,21). Two cases required surgery, aligning with Loperfido et al. (18) and Barkun et al. (20), who noted that early recognition and conservative management reduce morbidity. Cholangitis and Infection Post-ERCP cholangitis was seen in 0.8%, comparable to previous studies reporting 1–3% incidence (3,6,14). Sharma et al. (29) described multidrug-resistant organisms as emerging culprits, underlining the need for culture-guided antibiotics and timely biliary drainage. Mortality Procedure-related mortality in our study was 0.2%, consistent with international estimates (0.1–0.5%) (3,8,22). Causes included severe pancreatitis and perforation-related sepsis, reaffirming that mortality, though rare, remains tied to severe adverse events. Predictors and Procedural Factors On multivariate analysis, difficult cannulation, pancreatic duct injection, precut sphincterotomy, and prolonged procedure duration (>45 min) were independent risk factors. Similar results were reported by Testoni et al. (7,17), Kim et al. (18), and Elshaer et al. (23). Difficult cannulation increases papillary trauma and risk of inadvertent pancreatic entry, both strong predictors of PEP (4,5,7). Pancreatic duct injection contributes to hydrostatic and enzymatic injury, particularly if high-pressure contrast injection occurs (16,17). Prolonged procedures correlate with case complexity, repeated cannulation, and papillary edema (6,8). Our finding that trainee involvement slightly increased complications reflects global training experiences. Elshaer et al. (23) showed a mild rise in adverse events with supervised trainees but without significant increase in mortality. This underscores the importance of graduated responsibility and expert oversight in training programs. Comparison of Plastic vs Metal Stents Although not the main objective, our dataset showed that plastic stents were more frequently used in benign disease, while SEMS were preferred for malignant obstruction. Complication rates were similar, consistent with Almadi et al. (9), who found no difference in early complications but higher occlusion rates with plastic stents over time. Indian Disease Spectrum and Practice Implications The Indian ERCP case mix differs from Western countries due to higher gallstone prevalence, infectious cholangitis, and malignancy from gallbladder carcinoma (14–16). This necessitates procedural adaptations such as larger sphincterotomies, multiple stents, and repeat interventions, all of which can increase complication risk. However, our comparable complication rate demonstrates the safety of ERCP even in complex pathologies when performed in structured high-volume settings (10–14). The results also validate that adherence to standardized technique, selective cannulation strategies, and prophylactic measures effectively mitigate risk. Prophylaxis and Preventive Strategies The introduction of rectal NSAIDs, hydration with Ringer’s lactate, and prophylactic pancreatic stenting have revolutionized PEP prevention (3,5,12,13,24). Elmunzer et al. (5) demonstrated that rectal indomethacin reduced PEP by nearly 50% in high-risk cases. Subsequent meta-analyses and ESGE guidelines (3,24) strongly recommend these as standard care. Our center adopted routine indomethacin use in high-risk patients, contributing to the relatively low PEP rate. Similarly, wire-guided cannulation and limiting cannulation attempts (<10) have been proven to reduce PEP (6,7,17,19). Management and Outcomes Most complications in our cohort were mild or moderate and successfully managed conservatively. Only 2% required surgical or radiologic intervention. These outcomes mirror those reported by Adler et al. (8) and Dahale et al. (11). Patients with complications had a significantly longer hospital stay (median 7 days vs 2 days), emphasizing the clinical and economic impact of even mild events. Quality and Training Implications ERCP complication rates are recognized as key quality indicators for endoscopy units (8,25). Our data fall well within the ASGE recommended benchmarks (PEP <10%, bleeding <2%, perforation <1%, mortality <0.5%) (2,8).Continuous monitoring, periodic audits, and incorporation of simulation-based ERCP training can further improve safety (23,25,26). Strengths and Limitations Strengths: • Large dataset from a high-volume tertiary center over three years. • Comprehensive capture of procedural variables and outcomes. • Multivariate statistical analysis to identify independent predictors. • Limitations: • Retrospective design; potential underreporting of mild complications. • Single-center study; generalizability limited. • No long-term follow-up for late stent-related complications. • Variation in prophylactic NSAID use and hydration protocols among operators. Nevertheless, our study offers valuable region-specific insight into ERCP practice in Northern India, bridging the literature gap between Western and Asian data. Future Directions Future multicentric prospective Indian registries can refine local risk models, integrating real-time monitoring and uniform prophylactic protocols. Studies comparing early (within 24 h) vs delayed ERCP in cholangitis or gallstone pancreatitis may further optimize timing and outcomes (27,28). The integration of artificial intelligence (AI)-assisted cannulation and real-time risk prediction tools is another exciting frontier for complication prevention (30).

In this three-year retrospective audit of 1000 ERCPs, the overall complication rate (7.4 %) was well within international benchmarks. Difficult cannulation, pancreatic duct injection, and prolonged procedure duration were independent risk factors for adverse events. Most complications were manageable without surgery, and mortality was minimal. Ongoing audits, skill-based training, and strict adherence to prophylactic protocols can further reduce ERCP-related morbidity in Indian centers.

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