Endoscopic retrograde cholangiopancreatography in the elderly: results of a retrospective study and a geriatricians’ point of view

The incidence of biliary tract pathology is growing due to the overall aging of the population worldwide, and this is particularly evident among the number of those over the age of 80¹. Endoscopic Retrograde Cholangiopancreatography (ERCP) represents the gold standard exploratory technique for the treatment of biliary or pancreatic tract pathology, and it could be often performed with therapeutic intent by realizing procedures such as insertion of bile duct stents and/or endoscopic sphincterotomy. However, evidence about its safety in the elderly is still controversial.[1‐5] A recent systematic review by Day et al.[4] explored the issue of effectiveness and safety of ERCP in octogenarians (i.e. ≥80 years old) versus younger seniors and late adults, showing that perforation, hemorrhage, biliary infection, and other main complications of the procedure were not statistically different among the three groups. However, despite the sample size of the meta-analysis, patients did not undergo a comprehensive approach to be characterized. Instead of more inclusive tools, the frequency of symptoms, the proportion of some comorbid conditions (namely hypertension, diabetes, coronary heart and cerebrovascular diseases, and “others”), and the American Society of Anesthesiologists (ASA) physical status classification score were the parameters collected.[6] From a geriatric perspective, the assessment of older patients is an interdisciplinary process that should include multiple domains, such as functional and nutritional status, cognition, accurate evaluation of comorbidity, and many others[7].

In order to add knowledge to this scenario and to understand if this gap in patient’s assessment applies to our population, we retrospectively analyzed the clinical records of older patients undergoing ERCP in the endoscopy unit of an Italian university hospital. Our aim was to assess how the specialists in endoscopy evaluate patients undergoing ERCP, the success rate of this procedure, and the incidence of complications in octogenarians compared to that of younger seniors (aged < 80 years old).

The demand for ERCP is increasing in the elderly and it is important to know the procedure risks and benefits in older patients. The two study groups were different in terms of age, sex, CCI and ASA score.

The older group (ages 80 and above) had a significantly higher number of female patients and this is probably due to the different life expectancy between men and women. This data was recently confirmed in the literature [10].

The older group showed a lower mean CCI, thus raising a question about the existence of a possible selection bias. However, if we consider the age-adjusted CCI, the mean values were significantly higher in older patients. In order to perform ERCP procedures, these data suggest that gastroenterologists specializing in endoscopy probably rely on inclusion criteria that do not take into account the multi-faceted characteristics of the geriatric patient. However, the CCI – age-adjusted or not – should not be considered as a stand-alone assessment tool. Those inclusion criteria often imply that older subjects are selected for their apparent “fitness” according to comorbidity, which is a crucial limitation. Even the ASA physical status classification system - despite being validated for assessing fitness of patients undergoing surgery - cannot be considered as a stand-alone tool for the evaluation of elderly subjects scheduled for ERCP. Not surprisingly, ASA score is mainly a qualitative rather than a quantitative index, theoretically insufficient to describe the complexity of the geriatric population.

A further possible signal of selection bias is the fact that ASA III-IV patients were significantly prevalent in the older group, in potential contrast with the simultaneous presence of a lower index of comorbidity in this age group. Again, even by dichotomizing the CCI in < 4 versus ≥4, the younger group displays a higher number of patients with CCI ≥ 4 than the older one, confirming that patients scheduled for ERCP undergo uneven selection criteria. Those criteria tend to exclude the more comorbid elderly subjects from the procedure, presumably according to the assumption that higher comorbidity translates into higher incidence of complications and mortality related to this procedure.

We agree that several older patients are able to tolerate ERCP, and that older people with comorbidities are at higher risk for some complications compared to those without comorbid conditions,[11] but understanding the “big picture” goes beyond the mere collection of medical history or fitness status. When facing older individuals, a comprehensive geriatric assessment (CGA) should be considered as the preferable way to assess their health status in its entirety. The CGA considers the multiple aspects of the elderly, namely comorbid conditions, polypharmacy, functional level, cognition, and nutritional status among other factors which once combined provide a more reliable prognostic estimation than the ASA score or a comorbidity index alone. We are confident that the role of a CGA will be increasingly relevant for risk stratification and risk management of these patients, or at the very least, a useful guide for avoiding ERCP in subjects who have a high risk of experiencing more harm than benefits from the procedure.

Back to our findings in this study, they were consistent with the literature in terms of indications, diagnoses,[1, 10] and success rates (92.8% vs. 93.5%, for the younger and older group, respectively) [12‐15]. The frequencies of ERCP-related complications were 13.2% in the young group and 10.0% in the older, which is slightly higher than the rates reported in the literature (2.5% to 12%). ERCP-related death incidence was 0.7% and 0.5% respectively, in line with previous reports, [12‐25] though the only systematic review of ERCPs in the elderly suggests higher rates of death in octogenarians and nonagenarians than in younger patients.[4] We also observed that advancing age was not related to complications, neither in the case of the continuous variable, nor the dichotomized one (OR = 0.99, 95% C.I.: 0.95–1.02, p = 0.399; and OR 0.67, 95% C.I. 0.40–1.12, p = 0.128, respectively). This is in line with our hypothesis, i.e. that age per se does not carry more complications. However, the finding should still be interpreted carefully because of several limitations.

Neither the indications (given a priori) nor the diagnoses (given ex-post, during or after ERCP completion) resulted as significantly related to complications, and again this could be due to the above-mentioned selection bias. Unexpectedly, the type of invasive procedure performed during ERCP was not related with experiencing complications (Table 6).

Pertaining to the multivariate analysis, it should be noted that the sign of the relationship between CCI (dichotomized between < 4 vs. ≥4) and complications is negative, thus it seems that the higher the CCI class, the lower the risk of complications. This fact does not agree with the literature, but it should be interpreted. Indeed, Table 1 showed that a higher number of patients with CCI ≥ 4 belong to the 70–79 age group, and that they do not experience more complications than the older group, opening various interpretations but also confirming the potential impact of the selection bias for this procedure. However, the literature findings do not agree in terms of risk factors for the onset of complications [12‐16].

The first limitation of our study is represented by the relatively limited sample size (n = 363), though this is similar to that of other studies [3, 23, 26]. The size issue probably explains also part of the difference between findings in the literature. This also gives a possible reason for the absence of significant associations observed at the univariate and multivariate analyses. On the one hand, this is quite unexpected because some of them should be theoretically correlated with complications, e.g. the degree of invasiveness of the procedure (performing sphincterotomy+stent placement is different than an ERCP executed for diagnostic purposes only). On the other hand, those results could be due to the selection bias for this procedure, which is expected to alter the normal correlations, especially if the study population is somewhat limited in size.

In addition, due to the single-centered and retrospective design, our findings cannot be generalized to other acute care settings. Furthermore, we retrieved hospital records but we do not have information about the post-discharge phases of care of the studied ERCP-treated patients. Finally, a major limitation is the lack of a structured, homogenous assessment of the ERCP candidates pre-operatively, which translates to the selection bias enlightened by our analysis. The only study that tried to assess the ERCP-related risk in the elderly population considering multiple domains suggested to include the Duke Activity Status Index (DASI, ranging from 0 to 58.2) to evaluate the functional capacity of subjects with cardiovascular disorders, with higher scores indicating better functional status. Further studies are necessary to confirm the importance of multidimensional scores, i.e. one or more tools able to describe the older patient comprehensively [26].

Given these limitations, this study provides insight and paves the path for including more comprehensive assessment tools in future prospective investigations, which are strongly needed. The final objective is to better characterize the elderly patients pre-operatively and select candidates who will have the highest probability of benefiting from ERCP, reducing the risk of developing intra- and post-operative complications.

ERCP remains a procedure burdened by many known risks, especially if performed with urgency and in the elderly. Similar to many countries worldwide, the Italian population is progressively aging, [27] and the absolute number of older people that will need ERCP procedures specifically in the future will increase. The possible implementation of a user-friendly and rapid tool for older patients’ assessment will benefit both health professionals as well as their patients, reducing selection biases and improving their risk management. This will potentially and ultimately contribute to contain the incidence of post-ERCP complications and to test the real impact on the patient when the procedure is performed at an advanced age.