A Single-Center, Prospective Study Focused on Quality Indicators, Success Rate, Features, Outcomes, and Indications of Endoscopic Retrograde Cholangiopancreatography (ECRP) Practice at a Tertiary Care Hospital

Paraashar R Rai¹, Anand Bhandary P²* and Anand Ignatius P³

¹Resident, A.J. Institute of Medical Sciences and Research Center, Mangalore, India ²Department of General Surgery, Assistant Professor, A.J. Institute of Medical Sciences and Research Center, Mangalore, India ³Department of General Surgery, Professor, A.J. Institute of medical sciences & Research Centre, Mangalore, India

Conclusions: In our center's ERCP procedures are carried out by experienced surgeons wellversed with endoscopic proce- dures who achieve good procedural outcomes, meeting the quality standards and good procedural success. Even ERCP has some morbidity and mortality risk, it is a valuable tool for addressing pancreatobiliary disease. The technical success rates met or beyond the ASGE/American College of Gastroenterology Task Force recommendations which was the main objective of this study. When compared to other centers across the country and the western world, cannulation success rates are adequate and comparable to the set norms. Since ERCP seldom results in mortality and has low rates of peri-operative complications, it is regarded as a safe interventional biliary procedure. Keywords: Endoscopic Retrograde Cholangiopancreatography; (ERCP); Pancreatobiliary Disease; Choledocholithiasis; Sphincterotomy; Cholangitis; ERCP Stent; Post ERCP Pancreatitis(PEP)

Abbreviations

CBD: Common Bile Duct; ASGE: American Society of Gastrointestinal Endoscopy; ESGE: European Society for Gastrointestinal Endoscopy; ERCP: Endoscopic Retrograde Cholangiopancreatography; STROCSS: Strengthening the Reporting of Cohort Studies in Surgery.

Introduction

Any endoscopic procedure intended to cannulate the pancreatic duct or the common bile duct (CBD) is referred to as an endoscopic retrograde cholangiopancreatography (ERCP) procedure. Both benign and malignant pancreatic and biliary disorders are treated using ERCP. With a steep learning curve and the potential for major, life-threatening complications, it is a technically challenging treatment. Due to its relatively high complications rates, which range from 3 to 15%, ERCP remains one of the most technically challenging therapeutic endoscopic procedures [1].

The most common indications of ERCP are removal of choledocholithiasis, relieving bile duct obstruction by stent insertion in benign and malignant strictures, drainage of pancreatic fluid collection in acute on chronic pancreatitis, Biliary or pancreatic Sphincter of Oddi dysfunctions, ampullary carcinoma in poor surgical candidates to relieve obstruction and postoperative management of biliary perioperative complications [1].

Cholangitis, perforation, hemorrhage, and pancreatitis are the important complications of the procedure [2, 3]. The most frequent complication following ERCP is pancreatitis, which can occur in 1-7% of individuals and up to 25% of high-risk patients. A small percentage of individuals may experience severe pancreatitis, which can necessitate endoscopic or surgical procedures and prolonged stay in hospital. The majority of post-ERCP pancreatitis cases are mild to moderate [4].

With time, ERCP performance is evolving into a platform for increasingly sophisticated, therapeutic, and advanced procedures such as cholangioscopy and ERCP with altered anatomy. There is a steep significant learning curve for both technical endoscopic abilities and judgment during ERCP procedures during the training period. Therefore, completing such a difficult endoscopic treatment requires the right training, experience, and competence.As a result, the American Society of Gastrointestinal Endoscopy (ASGE) released an updated list of ERCP quality markers in 2015 [5]. A set of performance metrics for pancreatobiliary endoscopy was also released by the European Society for Gastrointestinal Endoscopy (ESGE) [6].

Therefore, the aim and objective was to assess, in a single tertiary center-based study, the indications, results, success rates, incidence, and risk factors for complications linked to endoscopic retrograde cholangiopancreatography (ERCP) procedure and validate the ASGE/American College of Gastroenterology Task Force recommendations and highlight upon the inicators.

Statistical Analysis

A computer running Microsoft Windows was used for data analysis. After being entered into a Microsoft Excel spreadsheet, the data was checked for errors. IBM Corp.’s SPSS Statistics for Windows (issued in 2024, Version 29.0; Armonk, New York, USA) was used for statistical analysis. Frequencies and percentages were used to display categorical variables. Univariate tests were performed to examine the association of having a complication with sex, age, procedure type, class, anesthesia use, antibiotic use, and grade of difficulty. A 2-sample t test was used to assess continuous variables, while a chi square test was used to analyze categorical variables. In order to assess the independent impacts of factors, while accounting for the contribution of the other variables in the model, multivariate logistic regression was carried out, incorporating into the model those variables that were determined to be significant on univariate analysis.

Furthermore, logistic regression analyses have been performed to examine the relationship between technical success and complications and medical experience. A P value of 0.05 was deemed statistically significant for every analysis. Although it is acknowledged that Bonferroni’s method of correction [9] for multiple testing of outcome data would eliminate all findings of statistical significance, with the exception of P values of 0.001, all P values are reported uncorrected for multiple testing of data. Therefore, the results should be interpreted as preliminary and intended solely for descriptive purposes in all other cases where nominal significance is mentioned. To examine the relationship between complications and patient satisfaction, other analyses were conducted. The chi squared test, Fisher’s exact test, and analysis of variance models are among the techniques employed for these analyses.

Results

In all, 948 patients underwent 1024 ERCP procedures. Over the period of five years, from October 1, 2018, to September 30, 2023, the study included 421 (43.4%) procedures in males and 579 (56.6%) procedures in females (mean age being 57.8 years, range from 3 - 76 years). 82.5% of the patients were classified as ASA I or II, 14.3% as ASA III, and 3.2 as ASA IV, according to pre procedure risk assessment. (ASA- American Society of Anaesthesiologists) 34.6% (354) were acute procedures, while 65.4% (670) were elective procedures. 74% of the procedures were grade 1 in difficulty, 16% were grade 2, and 10% were grade 3, according to the modified Schutz score [10]. 780 patients (76.2%) had a papilla in a naive state, while 244 patients (23.8%) had a prior sphincterotomy or stent insertion (Table 3).

Discussion

An important and diagnostic cum therapeutic procedure that is commonly used in the treatment of various pancreatobiliary pathologies is therapeutic ERCP. Although there is a chance of minor complications, ERCP is typically regarded as safe and effective. Most of the research and findings are derived from developed western nations [11]. Our objective of this literature was to provide an overview of ERCP practice in a developing nation such as India, noting success rates and complications that could be compared to previous research from developed countries with advanced centers and technology. (Rishabh Prakash Jain et.al. Procedural Outcomes Analysis of Endoscopic Retrograde Cholangiopancreatography Procedures at Tertiary Centre Hospital in South India) We evaluated 1024 patients who had therapeutic ERCPs performed at our facility for this study. In low volume centers, the ERCP success rate ranges from 76.0% to 80.3%, while in high volume centers, it ranges from 86.9% to 94.3% [12, 13, 14]. Our study’s success percentage, 86.76%, is nearly identical to earlier findings. Both benign and malignant disorders had success rates of 84.34% and 77.35%, respectively. Hilar stricture has a lower success rate than distal biliary stricture.

According to studies from academic institutions, 85.6– 98.1% of cases resulted in effective bile duct cannulation [15, 16, 17]. According to the ASGE quality statement for priority, stone removal should be less than 10 mm with normal anatomy and cannulation rates should be greater than 90%. 18 Both of the quality indicators were met in our study.

Pancreatitis is the one of the most common complications in big series following ERCP (PEP), accounting for 2% to 7% of procedures [18, 19, 20, 21, 22]. In contrast, 8–15% of procedures are linked to this complication in randomized trials, when reporting may be more reliable [23, 24]. Between 0.5 to 2% of individuals under-going ERCP experience hemorrhage [25, 26]. As anticipated, sphincterotomy or pre-cut is linked to this complication [26, 27]. Cholangitis complicates between 0.5% and 2% of ERCPs, according to the majority of large studies [28, 29]. The least frequent ERCP complication is perforation.26 According to large datasets, perforation complicates 0.1% to 1.8% of ERCPs [16, 27, 28, 29]. like the ones occurring in our case scenario in this study. The study we conducted found that our facility meets practically all ASGE procedural quality requirements.

The range of cardiopulmonary events or anesthetic complications includes catastrophic myocardial infarction, pulmonary embolism, respiratory failure, and cardiac arrest, as well as moderate, temporary hypoxia and hypotension.

Conclusions

The study found that skilled surgeons conduct ERCP successfully at high-volume centers, nearly achieving quality requirements. The study identified an unmet need to improve the quality of ERCP-related procedures, including anaesthesia techniques, microbiological surveillance, and training programs. Success requires ongoing training and skill maintenance. Therapeutic ERCP is now a highly effective and safe procedure in the hands of experienced endoscopist. The indications and success rates as well as morbidity and mortality are acceptable compared to those in earlier reports and published guidelines. In comparison to previous similar studies from the west and published guidelines, the indications, success rates, and rates of morbidity and mortality are all acceptable and within the frame work of the ASGE/ ESGE guidelines. Our findings tackle topics that have not been thoroughly examined before and, when combined with information from academic departments, offer a more comprehensive view of ERCP quality indicators.

Author Contributions

Conceptualization, writing original draft – Anand Bhandary Panambur Panambur Formal analysis, supervision and writing review – Anand Bhandary Panambur & Paraashar R Rai Compilation of relevant references and editing – Anand Bhandary Panambur & Anand Peter Ignatius

Funding Information

The authors did not receive any funding.

Conflict of Interest Statement

Authors declare that there is no conflict of interest.