This is one of the important process indicators with a performance target of more than 90%, as per ASGE/ESGE guidelines.7 A clear indication must be documented, and in cases of unclear indication, this should be explained and documented in the consent itself. This is extremely important, as the yield of ERCP in these clinical situations is usually low, and the risk of adverse events is higher and disproportionately severe. ERCP for such indications is often performed after appropriate patient consultation and consent, preferably at high-volume referral centers.

Antibiotics prior to the procedure can be considered in patients with clinical evidence or signs of cholangitis, in patients with biliary obstruction in whom complete drainage of the biliary tree cannot be achieved, and in patients who are at risk of infection.8

This is usually not a relevant clinical indicator as data has shown that even during randomized control trials, it may not reflect adverse events. However, expert opinion suggests that a well-trained endoscopist, trained specifically for ERCP, can perform safe and effective quality examinations, due to the increased complexity and risk of adverse events associated with the procedure. According to the available data, operators with varying levels of expertise and procedure volumes have varying results.9 Currently, this is usually not used as a quality indicator. The main issue is that different individuals may have different learning curves; therefore, it is extremely difficult to quantify the minimum number needed to gain expertise. Many studies and guidelines by various societies have tried to address this question, but there is still no consensus about who should be classified as a “trained” ERCPist.

All performance metrics depend on adequate reporting of adverse events. According to one study, endoscopists who performed approximately 50 yearly ERCPs had lower success rates and more adverse effects, whereas those who performed at least one sphincterotomy each week had fewer adverse events.5 Hence, the number of ERCP procedures performed by each operator, their success rates, and adverse events should be well documented. This is one of the important parameters across institutes, as most require clear documentation of intervention-based procedures. A recent proposal from a research team at the Erasmus Medical Center in Rotterdam, the Netherlands, suggested a self-assessment program to improve endoscopy quality measurement. The Rotterdam Assessment Form for ERCP was created from a form completed by each endoscopist who participated in the study.10 The form was completed after the procedure, and had both objective and subjective criteria. Despite limitations, such as the study was conducted in a single tertiary center and the impact of trainee involvement was not studied, the outcomes were significant. With a sample size of 1,651, the researchers concluded that there was no relationship between the volume and performance of practicing endoscopists. The endoscopist with the lowest volume did not perform worst. Since each individual has a different learning curve for ERCP, the use of the quantified numbers performing ERCP as a quality indicator can be controversial.

Successful cannulation of the desired duct (biliary or pancreatic) is one of the most important and stressful steps for successful ERCP. It is considered one of the priority indicators, but with caveats. However, this must be documented in all cases. Successful cannulation and an understanding of the different methods of cannulation are important aspects of training for ERCP. A meta-analysis suggested that cannulation rates (%) in practice are usually in the high 80% to 90%, with documented differences across the world.11 Some data suggest that quantifying successful biliary cannulation in native anatomy has implications for successful independent ERCP of the trainee.12 Ideally, recording cannulation rates should exclude abnormal anatomy, altered anatomy (due to previous surgeries), or failed examinations due to inadequate sedation. According to the established guidelines, in ERCP, endoscopists are expected to cannulate the duct of interest in >90% of procedures of mild to moderate difficulty. Although there is a caveat or point of contention, that it does not elaborate on the type or method of access achieved.13 The expert consensus of the ASGE/ACG task force recommended that physicians with consistently suboptimal cannulation rates (<80% success) should consider further training or discontinuing their ERCP practice and avoid attempting complex ERCP cases.

The UK Joint Advisory Group consensus statements for training and certification in ERCP, published in 2021, emphasize that while selective cannulation success rate is an important determinant of ERCP performance, it should not be used as the sole indicator of competence.14 We emphasize the fact that cannulation rate is an important parameter to assess the competence of an endoscopist, but the steps after cannulation are of equal importance. Cannulation is one step in the entire procedure, and the quality assessment should not stop at this step. Successful completion of the procedure requires many more skills than cannulation rate alone. There are various methods of achieving cannulation, other than selective cannulation, double-wire technique, pre-cut, fistulotomy, etc., all of which are methods to achieve cannulation but carry a significantly higher risk of adverse events. Hence, the evaluation of a trainee should include a component of the method used and its outcomes.

ERCP requires significant radiation exposure to the patient, which must be reduced to the lowest possible level. Factors that usually affect the radiation dose include patient body habitus, use of barriers, distance of the patient from the radiation source, magnification, oblique views and spot images, and the difficulty and longevity of the procedure. Fluoroscopy time and radiation dose should be documented if possible.

Stone extraction is one of the most important therapeutic procedures performed by endoscopists during ERCP. The size, number, location, and complete extraction of stones must be documented by the endoscopist. Cholangiographic anatomy, variations, and strictures must also be clearly documented. Individual extraction rates must be tracked and should be on par with standard rates across similar centers. This should be compared with a center of similar stature, as some expert endoscopy centers can achieve stone clearance irrespective of size in over 90% of patients.15 Studies have suggested that a trained endoscopist can clear the biliary duct of small-to medium-sized common bile duct stones up to 1 cm in diameter in 90% of cases by using sphincterotomy and balloon or basket stone extraction in patients with normal biliary anatomy. Outcomes related to difficult stones (large-diameter stones, stones above strictures, and stones in patients with altered anatomy) must also be documented and compared with standards for similar situations.

Each ERCP procedure should have a documented protocol for stent placement. This has multiple implications. The documentation should not only include whether the stent was successfully inserted, it should also reflect sufficient information about the indication, stricture location, stent size and type, and presence of post-surgical anatomy. These data will make comparisons and subsequent benchmarking easier. Stent placement is technically easier to achieve in patients with strictures below the hilum than in those with hilar obstruction. Competent endoscopists should be able to place stents for non-hilar obstruction in >90% of cases. Technical success versus clinical success of stent placement as a quality indicator can be debated. As clinical success depends on multiple variables and stenting is only a part of management, we believe that it is the technical skill that should be the quality indicator, and clinical outcomes alone should not be considered a quality indicator.16 The success rate of difficult situations, such as hilar tumors and post-transplant anastomotic strictures, should be tracked for benchmarking purposes.

Sedation protocols are used almost universally during ERCP. Periodic assessment, monitoring, and assessment of the vital signs of the patient are mandatory while using sedation during ERCP. Equipment for emergency resuscitation and a crash cart should be readily available. Availability of a trained anesthesiologist is usually recommended for ERCP. ERCP is a complicated procedure that typically takes longer to complete than routine gastro/colonoscopy. It has been shown that the failure rate of ERCP can be significantly higher if anesthesia has not been correctly administered. This higher failure rate can be caused by premature termination due to insufficient sedation. Sedation for ERCP varies between centers and anesthesiologists. Deep sedation with propofol and general anesthesia are options. General anesthesia has been shown to have higher successful ERCP rates, as duration is usually not a constraint. The decision should be based on procedural and patient factors. Some hospitals prefer to intubate only in the most difficult cases, which are expected to take longer to complete. Deep sedation with propofol can usually be utilized for ERCP that do not require a longer duration or are less complex, whereas for advanced, longer duration procedures, it is better to intubate the patient for safety.17 Use of moderate sedation or conscious sedation may lead to difficulties in accurate assessment and completeness of the procedure, hence, most experts use deep sedation or general anesthesia for ERCP.

The ERCP report should include details of the desired duct cannulation success, photo documentation of all the essential steps including fluoroscopic images, depiction of the events in chronological order, outcomes, adverse events, and overall impression of the endoscopist. The type of anesthesia utilized and any untoward effects of anesthesia on the patient should also be mentioned. Unintentional pancreatic duct cannulation or contrast injection should be mentioned. Clear and appropriate documentation of ERCP findings, without concealment of facts, helps clinicians who are directly involved with patient clinical care in making appropriate patient management decisions.

Adverse events are common in all ERCP and therapeutic procedures. It is important that they are recognized early, and steps are taken to manage them once an untoward incident has occurred. Immediately recognized adverse events should be reported along with a management plan. Bleeding, allergic reactions, cardiopulmonary events (including aspiration), perforation, and post-ERCP pancreatitis (PEP) are the main concerns that must be addressed.

PEP is one of the priority quality indicators in ERCP. It is one of the benchmarks that has been utilized across medical institutions and has significant medicolegal implications.

The incidence of PEP must be documented and tracked. The current rate of PEP (1%–7%) has many related factors, such as operator skill, experience, and type of ERCP procedures undertaken. Therefore, deciding a single performance target for all ERCPs for this indicator is difficult. As multiple parameters are involved, it is important to know the operator’s or unit’s rate of PEP, which has been documented and reported as a quality indicator.18 Various methods have been described and reviewed to minimize PEP. One of the most important parameters is adequate pre-procedural hydration of the patient, which must be part of the pre-procedural protocol. Use of rectal suppositories must be documented, and clear instructions about local protocols must be given to endoscopy staff. Special prophylaxis for PEP, including pancreatic stent placement and the use of non-steroidal anti-inflammatory drugs, should be documented. According to the guidelines, ESGE now recommends PEP prophylaxis using and documenting rectal non-steroidal anti-inflammatory drug administration for all patients undergoing the procedure and pancreatic duct stenting in high-risk cases, to reduce the incidence of PEP.

Duodenal perforation is a serious complication of ERCP. A classification system has been previously described for duodenal perforation and its mechanisms.19 This adverse event has an important bearing on post-procedural management of the patient. It is important that it is recognized early. The procedure can usually be completed even if on table perforation has been identified. An experienced endoscopist should attempt to close the perforation, if feasible, using standard accessories and newer over the scope clips. A naso-jejunal tube for feeding can be placed if a longer duration of stay is anticipated owing to perforation.

The rate of ERCP-related perforations and related information should be recorded at the operator level. Documentation should include the level of perforation and management (conservative or surgical intervention). Because perforation rates are very low (0.1%–0.6%),20 the denominator of cases performed required to generate reliable individual endoscopist perforation rates is unknown, and hence, a reference data point is usually not available for this quality indicator.

The usual cause of bleeding during ERCP is sphincterotomy using electrocautery. The rate of clinically significant hemorrhage associated with ERCP is approximately 1%, with most cases involving mild, intraluminal bleeding.

With more complex procedures, such as ampullectomy and cystogastrostomy, the risk of bleeding increases. The bleeding risk is also dependent on patient factors, such as the use of antithrombotic agents and coagulopathy from any cause, and operator-dependent factors, such as the angle of cutting and amount of electrocautery used. Other factors that have been shown to increase the risk of bleeding include cholangitis, anticoagulant therapy within three days of the procedure, and low endoscopic caseload. The risk of bleeding is almost nil in patients undergoing ERCP without sphincterotomy. Aspirin can be safely used in patients with bleeding.21 All factors that could lead to hemorrhage, level of bleeding, and medications should be recorded and tracked.

Adverse events occurring within 14 days of the procedure should be documented. Efforts to monitor and improve the collection of delayed data on post-ERCP adverse events will generate more reliable outcome data for this procedure in the future. However, this may impact the cost of the procedure. Currently, it is not used as post-procedure quality indicator.

Among the indicators mentioned above, there are certain indicators for which objective criteria have been established and validated, to improve patient outcomes. Clear documentation for these is a must and should be completed at every institute or operator level. These are usually relatively easily measurable; however, their implications are prone to variability across studies. They are as follows: (1) selection of an appropriate indication, (2) cannulation rate, (3) stone extraction success rate, (4) stent insertion success rate, and (5) frequency of PEP.