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Efficacy and safety of endoscopic retrograde cholangiopancreatography in patients over 75 years of age
Shuangping Wang1, Qifeng Lu1, Yabai Zhou1, Hao Zhang2
1 Department of Gastroenterology, Fuyang People's Hospital, Fuyang, P.R. China
2 Department of Clinical Medicine, Wannan Medical College, Wuhu, P.R. China
|Date of Submission||18-Oct-2021|
|Date of Acceptance||31-Jan-2022|
|Date of Web Publication||03-Mar-2022|
Department of Gastroenterology, Fuyang People's Hospital, No. 501, Sanqing Road, Yingzhou District, Fuyang 236000
Source of Support: None, Conflict of Interest: None
Background: To investigate the efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP) in elderly choledocholithiasis patients compared with younger groups.
Methods: This was a case–control study conducted from January 2018 to December 2020 at Fuyang People's Hospital, with 596 patients included. Patients who underwent ERCP were classified as two groups based on age stratification definitions from the National Institute of Health and the World Health Organisation: Patients <75 ages (n = 204) and patients ≥75 ages (n = 392). Demographic characteristics, details of endoscopic therapy, complications were retrospectively reviewed and compared between two groups. The subgroup was pre-formed to further explore the efficacy and safety of ERCP in the elderly population.
Results: Between patients ≥75 ages and patients <75 ages, there were no significant differences in the complete stone removal rate and a second ERCP. Intubation difficulty (odds rate [OR]: 1.723, 95% confidence interval [CI]: 1.118–2.657) and longer ERCP operation time (β = 4.314, 95% CI: 2.366–6.262) were observed in the elderly group at a higher frequency than the younger group. Elder patients were more likely to have intra-operative complications (χ2 = 18.158, P < 0.001), and post-operative complications (χ2 = 8.739, P = 0.003). In the subgroup group, ERCP was efficacious and safe in elderly patients with comorbidities.
Conclusions: ERCP may be efficaciously performed on elderly patients. However, intra-operative and post-operative complications of ECRP should also be taken into consideration when selecting therapeutic options.
Keywords: Cholelithiasis, efficacy, elderly, endoscopic retrograde cholangiopancreatography, safety
|How to cite this URL:|
Wang S, Lu Q, Zhou Y, Zhang H. Efficacy and safety of endoscopic retrograde cholangiopancreatography in patients over 75 years of age. J Min Access Surg [Epub ahead of print] [cited 2022 May 28]. Available from: https://www.journalofmas.com/preprintarticle.asp?id=339060
| ¤ Introduction|| |
Choledocholithiasis is common and frequently occurring diseases of the digestive system, with an incidence rate of 3%–11% in China, and the incidence rate increases with age.,, 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. The number of older patients undergoing therapeutic ERCP is increasing as a result of the rising life expectancy and aging society in many countries. However, ERCP is an invasive procedure and is associated with some complications.,, A higher incidence of periprocedural complications might be expected in elderly patients. Although procedural complications are not age related, significantly high prevalence of comorbidity, such as cardiopulmonary and cerebrovascular diseases, in the elderly may be expected to increase periprocedural morbidity and mortality. Therefore, the possible benefits and risks of ERCP need to be carefully assessed for older patients.
ERCP has been continuously applied in clinical practice. It enters the bile duct through the duodenal scope, and the calculi can be incisive at the sphincter of the nipple to relieve obstruction according to the size of the common bile duct stone, with good clinical effect and less trauma., Previous studies have demonstrated successful cannulation of the bile duct in 86%–98% of cases in the elderly., However, the difficulty of complete extraction of common bile duct stones and myocardial injury in the elderly have also been reported. There is the dearth of studies on the efficacy and safety of ERCP in the elderly. Evidence comparing ERCP in young and elderly patients are also limited. A better understanding of the efficacy and safety of ERCP in the elderly is crucial to balance the risks and benefits and to provide better information for elderly patients to decide whether to accept ERCP.
Therefore, the aim of this study was to explore the efficacy and safety of ERCP in patients aged ≥75 years compared with younger choledocholithiasis patients and to identify the elderly who may benefit from ERCP surgery.
| ¤ Methods|| |
Study design and patients
This retrospective observational study was conducted at Fuyang People's Hospital. A total of 596 consecutive patients who underwent therapeutic ERCP were enrolled from January 2018 to December 2020. The inclusion criteria were as follows: (1) age ≥18 years old; (2) patients with choledocholithiasis diagnosed by magnetic resonance cholangiopancreatography, computed tomography (CT) or abdominal colour Doppler ultrasound; (3) patients receiving ERCP treatment; (4) patients with complete clinical data.
Exclusion criteria were: (1) failure of ERCP intubation due to pyloric obstruction, stenosis, duodenal diverticulum, etc.; (2) no bile-duct stones found in ERCP; (3) patients with a history of upper abdomen surgery and severe abdominal cavity adhesion that cannot undergo ERCP; (4) patients with severe cardiopulmonary or liver and kidney dysfunction who cannot tolerate anaesthesia and surgery; (5) patients with suspected acute pancreatitis or acute attack of chronic pancreatitis before surgery; (6) patients with coagulation dysfunction; (7) patients who participated in other clinical studies within 1 month before being selected for the study. Patients who underwent ERCP were classified as two groups: Patients <75 ages and patients ≥75 ages. Age stratification was based on definitions from the National Institute of Health and the World Health Organisation.
Data collected via case report form, including: (1) patient characteristics: Age (years), gender, body mass index (BMI, kg/m2), systolic blood pressure (SBP, mmHg), diastolic blood pressure (DBP, mmHg), respiration (times/second), body temperature (°C), heart rate (times/min); (2) comorbidities: Hypertension, diabetes, coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), chronic renal insufficiency, malignant tumour, periampullary diverticula; (3) disease characteristics: Number of gallstones, the maximum diameter of stone, inner diameter of the common bile duct.
The primary outcome was the complete stone removal rate. The secondary outcome included rate of a second ERCP, intubation difficulty rate, ERCP operation time, intra-operative bleeding, post-operative hospital stay and intra-operative complications (decrease blood pressure, decreased blood oxygen saturation, bleeding, gastrointestinal perforation, etc.), post-operative complications (including post-operative pancreatitis, post-operative hyperamylasaemia, post-operative biliary tract infection, post-operative bleeding, perforation, bile leakage, incision complications), and cardiopulmonary complications (hypoxemia, hypotension, bradycardia, tachycardia, pneumonia).
Intra-operative gastrointestinal perforation is defined as a perforation that is caused by the entry of the duodenoscope, is relatively large, and requires surgical intervention. Post-operative perforation refers to a small perforation of the duodenal papilla, which occurs before and after stone removal and is caused by incision, dilation or severe stone removal and is confirmed by CT examination or cholangiography.
Before performing ERCP, informed consent was obtained from each patient and/or caregiver. Diazepam in combination with pethidine was administered. All of the patients underwent continuous monitoring by electrocardiograph, blood pressure, and percutaneous oxygen saturation during the operation. After completing the ERCP pre-operative preparation, the patient lied in the prone position, with the head tilted to the right, and the lens was taken from the mouth to observe whether the oesophagus and stomach have ulcers, stenosis and other diseases. The main nipple was found on the inner wall of the duodenum, and the morphology of the nipple was examined to see whether there was inflammation, space occupying, diverticulum and other diseases. After the guidewire was inserted into the contrast catheter (if intubation is difficult, pre-nipple incision is performed), the contrast agent is injected into the bile duct, the diameter of the common bile duct to see whether it is dilated and narrowed, and observed the size, location and number of stones. Inserted the incision knife, routinely cut the duodenal papillary sphincter, cut about 1.0 cm, and ensured there was no bleeding from the wound. After crushing the stone with the gravel basket, used the stone removal basket and the stone removal balloon catheter to remove the stone, and finally performed the imaging again to ensure that the stone was removed. Routine endoscopic nasal bile-duct drainage was performed, the guidewire was withdrawn after the operation, and the nasal bile duct was properly fixed.
The measurement data of normal distribution were described as mean standard deviation (mean ± standard deviation), using Student's t-test for comparison between the two groups. Non-normal distribution was described was exhibited as (M [Q1, Q3]), and comparison between the two groups was performed using the Mann-Whitney U rank-sum test. Enumeration data were described in terms of the number of cases and composition ratio (n [%]). The Chi-square test or Fisher's exact probability method was used for comparison between groups. Logistic regression was pre-formed to investigate the influence of age on primary and secondary outcomes. Model 1 was unadjusted model, Model 2 was a model adjusting for gender and BMI, and Model 3 was adjusting for gender, BMI, number of gallstones, maximum diameter of stones, inner diameter of the common bile duct, hypertension, diabetes, CAD, COPD, malignant tumours, and periampullary diverticula. Subgroup analysis was performed to further explore efficacy and safety of ERCP in the elderly population. Receiver operating characteristic curve was applied using R4.02 software (Institute for Statistics and Mathematics, Vienna, Austria). All statistical tests were conducted by two-side tests, and P < 0.05 was considered to be statistically significant. SAS (version 9.4, SAS Institute Inc., NC, USA.) statistical analysis software was used for statistical analysis.
| ¤ Results|| |
Differences of basic characteristics between <75 ages patients and ≥75 ages patients
A total of 596 patients were included in this study, with 392 patients were ≥75 years, and 204 patients were <75 years. The analysis of differences of basic characteristics between two groups are summarised in [Table 1]. BMI (t = 4.49, P < 0.001) and DBP (t = 3.56, P < 0.001) in the age ≥75 group were lower than those in the age <75 group, with average BMI 22.89 ± 2.00 kg/m2 and average DBP 70.70 ± 12.73 mmHg in patients ≥75 years and average BMI 23.66 ± 1.98 kg/m2, average DBP 74.55 ± 12.12 mmHg in patients <75 years. Number of gallstones ≥2 (χ2 = 26.953, P < 0.001), hypertension (χ2 = 43.441, P < 0.001), diabetes (χ2 = 14.014, P < 0.001), CAD (χ2 = 33.109, P < 0.001), malignant tumour (χ2 = 5.832, P = 0.016) were more frequent in patients ≥75 years. Moreover, the maximum diameter of stone (Z = −7.359, P < 0.001), the inner diameter of common bile duct (Z = −9.096, P < 0.001), SBP (t = −4.98, P < 0.001) were higher in elderly patients.
|Table 1: Differences analysis of basic characteristics between two groups|
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Differences of the primary outcome and secondary outcome between <75 ages patients and ≥75 ages patients
Differences analysis of primary outcome and secondary outcome between the two groups are presented in [Table 2]. The complete stone removal rate of ≥75 years old group was lower than that of <75 years old group. The patients ≥75 ages had a higher risk of intubation difficulty (χ2 = 6.033, P = 0.014), a second ERCP or surgical (χ2 = 6.561, P = 0.010), longer ERCP operation time (t = −7.82, P < 0.001), more intra-operative bleeding (Z = −4.861, P < 0.001), whereas had a lower rate of complete stone removal (χ2 = 10.957, P < 0.001). depicts the efficacy differences between the two groups. [Figure 1] shows the ERCP operation time between two groups. [Figure 2] presents intra-operative bleeding between two groups.
|Figure 1: Endoscopic retrograde cholangiopancreatography operation time between two groups|
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|Table 2: Differences analysis of primary outcome and secondary outcome between two groups|
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Analysis of primary outcome and secondary outcome endoscopic retrograde cholangiopancreatography between <75 ages patients and ≥75 ages patients
Model 1 results showed that the complete stone removal rate in patients ≥75 ages was reduced (odds ratio [OR]: 0.309, 95% confidence interval [CI]: 0.149–0.641, P = 0.002), while the risk of a second ERCP (OR: 2.247, 95% CI: 1.193–4.232, P = 0.012), intubation difficulty (OR: 1.586, 95% CI: 1.096–2.294, P = 0.014), and longer ERCP operation time (β = 6.598, 95% CI: 4.857–8.337, P < 0.001) increased. In model 2, lower complete stone removal rate (OR: 0.311, 95% CI: 0.149–0.653, P = 0.002), increased risk of a second ERCP (OR: 2.328, 95% CI: 1.223–4.431, P = 0.010), higher risk of intubation difficulty (OR: 1.585, 95% CI: 1.087–2.311, P = 0.017), longer ERCP operation time (β = 6.710, 95% CI: 4.929–8.492, P < 0.001) in patients ≥75 ages were observed. There was no significantly difference between patients <75 ages patients and patients ≥75 ages in complete stone removal rate (OR: 0.632, 95% CI: 0.260–1.533, P = 0.310) and a second ERCP (OR: 1.168, 95% CI: 0.531–2.576, 0.699) in model 3. While the risk of having difficulty intubation (OR: 1.723, 95% CI: 1.118–2.657, P = 0.014), and longer ERCP operation time (OR: 4.314, 95% CI: 2.366–6.262, P < 0.001) were more frequent in patients ≥75 ages. The result of analysis of efficacy of ERCP between <75 ages patients and ≥75 ages patients are shown in [Table 3].
|Table 3: The result of analysis of the efficacy of endoscopic retrograde cholangiopancreatography between two groups|
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Analysis of complications of endoscopic retrograde cholangiopancreatography between <75 ages patients and ≥75 ages patients
The results showed that ≥75 ages patients were more likely to have intra-operative complications (χ2 = 18.158, P < 0.001), decreased blood oxygen saturation (χ2 = 32.229, P < 0.001), post-operative complications (χ2 = 8.739, P = 0.003) and cardiopulmonary complications (χ2 = 13.053, P < 0.001). The differences in complications between the two groups are described in [Table 4] and [Figure 3].
|Table 4: Differences of complications of endoscopic retrograde cholangiopancreatography between two groups|
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Subgroup analysis of efficacy and safety of endoscopic retrograde cholangiopancreatography in ≥75 ages patients
Subgroup analysis results are reported in [Table 5]. Among male subgroup, patients with ages ≥75 had a higher risk of intra-operative complications (OR: 3.422, 95% CI: 1.535–7.631), while there were no differences between the two groups in stone removal, a second ERCP, intubation difficulty, ERCP operation time, intra-operative bleeding, post-operative hospital stay, and post-operative complications. In the female subgroup, increased age was associated with a higher risk of intra-operative complications (OR: 2.505, 95% CI: 1.298–4.835) and post-operative complications (OR: 2.385, 95% CI: 1.446–3.931). Moreover female patients ≥75 years of age had an increased risk of having intubation difficulty (OR: 1.972, 95% CI: 1.122–3.463), longer ERCP operation time (β = 5.010, 95% CI: 2.373–7.648), and more intra-operative bleeding (β = 1.203, 95% CI: 0.254–2.151). Moreover, female patients ≥75 years of age had a lower rate of complete stone remove (OR: 0.181, 95% CI: 0.036–0.905).
|Table 5: Subgroup analysis of efficacy and safety of endoscopic retrograde cholangiopancreatography in ≥75 ages patients|
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Among patients with BMI between 18.5 and 23.9, the incidence of intra-operative complications increased in those aged ≥75 years (OR: 1.756, 95% CI: 1.459–5.204), but there was no statistically significant difference in post-operative complications. And patients ≥75 years of age had an increased risk of intubation difficulty (OR: 2.357, 95% CI: 1.351–4.112), and longer ERCP operation time (β = 5.141, 95% CI: 2.672–7.610). Among patients with BMI over 23.9, intra-operative complications (OR: 3.048, 95% CI: 1.297–7.162) and post-operative complications (OR = 2.257, 95% CI: 1.189–4.288) were more common in the ≥75 age group.
Among patients with one stone, the incidence of intra-operative complications increased by 1.605-fold (OR: 2.605, 95% CI: 1.473–4.608) and post-operative complications increased by 0.858-fold (OR: 1.858, 95% CI: 1.208–2.858) in patients ≥75 years of age. Patients aged 75 or higher had a longer ERCP operation time (β = 4.447, 95% CI: 2.288–6.606), more intra-operative bleeding (β = 0.545, 95% CI: 0.015–1.074). Among patients with a number of stones ≥2, age increased intra-operative complications (OR: 3.899, 95% CI: 1.129–13.470).
In the subgroup with the maximum stone diameter <8, the incidence of intra-operative complications (OR: 3.093, 95% CI: 1.371–6.977) and post-operative complications (OR: 1.997, 95% CI: 1.084–3.682) increased in patients aged ≥75 years. And patients aged 75 or higher were with longer ERCP operation time (β = 5.991 95% CI: 3.103–8.878) and more intra-operative bleeding (β = 0.800, 95% CI: 0.261–1.360). In the subgroup with the maximum stone diameter ≥8, increasing age increased the intra-operative complications (OR: 2.641, 95% CI: 1.367–5.102). While ERCP operation time lasted longer in people ≥75 years (β = 3.149, 95% CI: 0.481–5.817).
Among patients with inner diameter of common bile duct <15, the incidence of intra-operative complications increased by 2.820-fold (OR: 3.820, 95% CI: 1.895–7.702) in patients ≥75 years old. However, longer ERCP operation time was observed in patients ≥75 years (β = 4.890, 95% CI: 2.302–7.479). In the subgroup of patients with the inner diameter of the common bile duct ≥15, advanced age was associated with an increased incidence of post-operative complications (OR: 2.074, 95% CI: 1.062–4.051). While a longer ERCP operation time was also found in people ≥75 years of age (β = 2.302, 95% CI: 0.379–6.705).
Among people with hypertension, there was no statistically significant between the two groups in stone removal, a second ERCP rate, intubation difficulty, ERCP operation time, intra-operative bleeding and post-operative hospital stay, intra-operative and post-operative complications. In patients with diabetes, there were also no statistically significant differences between the two groups in difficulty intubation, ERCP operation time, intra-operative blood loss, intra-operative complications, post-operative complications, and post-operative hospital stay. Among people with CAD, no statistical differences were found between the two groups in a second ERCP rate, intubation difficulty, ERCP operation time, intra-operative blood loss, intra-operative complications, post-operative complications, and post-operative hospital stay.
| ¤ Discussion|| |
The number of patients aged 75 years or older undergoing ERCP is increasing as a result of the increase in life expectancy, and efficacy and safety of ERCP in elderly patients should be ensured. In this study, we explored the efficacy and safety of ERCP in patients aged ≥75 years compared with younger choledocholithiasis patients. Our results indicated that ERCP was efficacious in elderly patients. However, the risk of intubation difficulty and ERCP operation time increased with increasing age. Moreover, the incidence of some complications of ERCP appears to have increased in elderly patients. In our subgroup analysis, ERCP was effective and safe in elder patients with comorbidities.
In this study, ERCP can be efficaciously performed on elderly patients. In a study of ERCP in elderly patients with the Hispanic origin, it was found that the efficacy of ERCP in patients aged 75 and over was similar to that of younger patients. Iida et al. reported that ERCP in patients aged 85 years or older could be used effectively. Similar success rates of ERCP between the elder and young were reported in multiple studies., Regarding procedure outcomes, ERCP duration was longer in the elder group. This might be due to the difficulty of clearing more numerous and larger bile duct stones in elderly patients. In addition, we found that increasing age was associated with the increasing risk of having difficulty intubation. Chong et al. reported difficult cannulation of the common bile duct was more frequent in the elderly. Difficult cannulation increased the risk of post-ERCP complications., Ukkonen et al. found that the risk of pancreatitis was almost sevenfold in patients with whom cannulation was difficult. This may be due to difficulty cannulation and repeated intubations leading to sphincter damage. For patients with difficulty in intubation, various indicators and signs should be closely observed after surgery to prevent complications.
Regarding complications, our result indicated that intra-operative and post-operative complications of patients underwent ERCP might be influenced by age. The incidence of periampullary diverticula in elderly patients was significantly higher. It may be caused by increasing age, degenerative changes of the intestinal wall combined with congenital muscular dysplasia, and external herniation of the intestinal wall of the weak area of the biliopancreatic confluence due to intraintestinal pressure. Periampullary diverticula increased the incidence of biliary tract disease and even affected the success rate of ERCP intubation. A study demonstrated that among octogenarians, cardiopulmonary adverse events were by far the most frequent type of adverse event, while non-agenarians were at higher risk of ERCP-related bleeding and cardiopulmonary adverse events. Several factors could explain these findings, including that these elderly patients may have more or more severe comorbidities, take more prescribed medications, or exhibit greater sensitivity to sedation. The complications of ERCP therapy in the elderly deserve attention. Special care before receiving ERCP and strategies to minimise adverse events in elderly adults are required.
The general state of a patient's health may play an important role in determining the outcome of any invasive treatments. Previous studies have shown that higher prevalence of comorbidities in elderly patients underwent ERCP,,, which are consistent with our findings. However, no significant difference in the presence of ERCP efficacy and safety in elderly patients with comorbidities in our subgroup. This is supported by a study that concluded that individuals older than 65 years tolerate laparoscopic procedures extremely well, despite underlying comorbidities. Tohda et al. also found that there was no relationship between comorbidities and ERCP-related complications. When facing older choledocholithiasis patients with comorbidities, ERCP can be applied.
The strengths of the current study need to be mentioned. In this study, we adjusted for confounding factors to avoid bias. Several limitations associated with the present study warrant mention. First, this work was a single-centre retrospective design, with a limited population, which might either lack the scientific precision or external validity needed to assist widespread changes in practice. Second, we failed to collect some variables, for example, the location of the stone that may also have an impact on the efficacy and safety of ERCP. Thirdly, we did not monitor long-term outcomes in patients who underwent ERCP in this study. Prospective studies with long-term follow-up periods based on a large population will be required.
| ¤ Conclusions|| |
This study demonstrates that ERCP is effective and safe for the treatment of choledocholithiasis in the elderly, especially for patients with comorbidities. However, it is necessary to pay attention to the occurrence of complications. This study may be helpful for clinical decision-making and comparative effectiveness and safety analyses when choosing ERCP for the elderly.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]