Abstract
Background and Aims
In patients awaiting cholecystectomy, the role of endoscopic biliary sphincterotomy (EST) with biliary stenting is controversial. We aimed to assess the impact of biliary stenting in these patients.
Methods
The Nationwide Readmissions Database (2016-2020) was queried to identify adult hospitalizations with cholelithiasis and choledocholithiasis that underwent ERCP with EST without biliary stenting (group 1) and biliary stenting (group 2). Readmission characteristics, post-ERCP pancreatitis (PEP), mean length of hospital stay (LOS), and mean total hospitalization charge (THC) were analyzed.
Results
For all biliary events, the risks of 30-day (1.18% vs .67%; adjusted hazard ratio [aHR], 1.78, 95% confidence interval [CI], 1.55-2.04; P < .001), 60-day (2.12% vs 1.04%; aHR, 2.0; 95% CI, 1.82-2.28; P < .001), and 90-day (2.66% vs 1.27%; aHR, 2.07; 95% CI, 1.86-2.30; P < .001) readmissions were higher in group 2 than in group 1. Similarly, the risks of 30-, 60-, and 90-day readmissions for choledocholithiasis, cholecystitis, cholangitis, and gallstone pancreatitis, and mean LOS and THC were higher in group 2 than in group 1. After adjusting for confounders, group 2 had higher rates of readmission for PEP within 48 hours after hospital discharge (.05% vs .03%; adjusted odds ratio, 1.93; 95% CI, 1.05-3.52; P = .032) compared with group 1, whereas there was no statistical difference in the rates of PEP from 48 hours to 7 days after hospital discharge between the groups.
Conclusions
For biliary events, patients with biliary stenting had higher readmission risk, LOS, THC, and PEP within 48 hours after discharge compared with nonstented patients.
Gallstones and related diseases are common and lead to significant morbidity, mortality, and health care utilization in the United States.1,2 Recent estimates assessing the cumulative burden of GI, liver, and pancreatic disease in the United States found that cholelithiasis was the physician diagnosis for 863,000 office visits and 327,000 emergency department visits in 2016. Taken together, cholelithiasis and cholecystitis were the second most common disease diagnoses and fifth most common cause of 30-day readmissions in U.S. hospitals in 2018.3 Although most patients with cholelithiasis remain asymptomatic, adverse events, including choledocholithiasis, cholangitis, cholecystitis, and pancreatitis, often occur.4 It has been reported that among patients with gallstone pancreatitis, concurrent choledocholithiasis may be present in up to 15%.5,6
Cholecystectomy remains a mainstay of treatment for patients with gallstone pancreatitis as well as for those with cholelithiasis and choledocholithiasis after stone clearance.7, 8, 9, 10, 11 Among patients who do not undergo cholecystectomy after acute gallstone pancreatitis, endoscopic biliary sphincterotomy (EST) has been shown to reduce biliary events, particularly, further episodes of pancreatitis during the follow-up period.12, 13, 14 In addition, to maintain patency of the biliary system until definitive surgery can be performed, biliary stents are commonly placed to maintain drainage and reduce the risk of jaundice or cholangitis. Current consensus guidelines recommend placement of biliary stents to facilitate removal of difficult choledocholithiasis or irretrievable biliary stones that warrant biliary drainage.15,16 However, the role of routine prophylactic biliary stenting after EST and stone clearance, before cholecystectomy, remains unclear.17
We conducted a propensity-matched analysis of the U.S.-based National Readmissions Database (NRD) to assess the effect of biliary stenting after EST in reducing the recurrence of adverse events among patients awaiting cholecystectomy.
Methods
Data source
In this retrospective study, we used the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project NRD from 2016 to 2020. The NRD is the largest multiethnic publicly available all-payer inpatient health care readmissions database in the United States.
Study population
The International Classification of Diseases, Tenth Revision (ICD-10) coding system was used to identify all adult (≥18 years old) hospitalizations with cholelithiasis and choledocholithiasis that underwent ERCP with EST. This population was further divided into 2 distinct groups, which included patients that received ERCP with EST without biliary stenting (group 1) and those that underwent ERCP with EST with stent placement (group 2).
Individuals <18 years of age, traumatic admissions, and elective admissions, as well as patients with biliary strictures and pancreaticobiliary malignancies, were excluded from the analysis. Each patient included in the NRD has an assigned unique database identification number that is used to identify subsequent admissions. Using this unique identifier, we included only the first readmission within the timeframe of analysis to avoid multiple inclusions of the same patient in the data set. Patients who underwent cholecystectomy within 2 weeks after discharge also were excluded to ensure they were not captured in our readmission analysis. Furthermore, admissions in December, admissions in November and December, and admissions in October, November, and December were excluded for the 30-day, 60-day, and 90-day analyses, respectively, to avoid missing readmissions that could have spanned to the next calendar year and thus recorded in the next data set file with different identifiers.
Study outcomes
The primary outcome of the study was 30-, 60-, and 90-day readmissions for a biliary event (choledocholithiasis, cholecystitis, cholangitis, or gallstone pancreatitis). Readmission rates were calculated for all biliary events and for each individual cause. The secondary outcomes included inpatient mortality during readmission, readmission for post-ERCP pancreatitis within 48 hours and from 48 hours to 7 days after discharge, length of stay (LOS) at readmission, and total hospitalization charge (THC). The THC was adjusted for inflation based on the Consumer Price Index for the health care sector, as maintained by the U.S. Bureau of Labor and Statistics.
Statistical analysis
All statistical analyses were performed with the use of Stata version 18 software (StataCorp, College Station, Tex). The sampling design in NRD is such that it produces a weighted sample that can be used to generate nationally representative results. A multivariate Cox regression analysis was used to obtain adjusted hazard ratios (aHRs) for all clinical outcomes with the referent cohort being those that underwent ERCP with EST without biliary stenting, and adjusting for all potential confounders. Continuous variables were compared using the Student t test. The mean LOS and THC were compared between the 2 groups by means of a multivariate regression analysis while adjusting for all potential confounders. A P value <.05 was considered to be statistically significant for all analyses.
Results
Baseline characteristics
There were a total of 176,575, 160,797, and 144,207 index hospitalizations in group 1 at 30, 60, and 90 days after the initial admission. Among group 2, 60,111, 54,711, and 49,065 index hospitalizations were identified at the 30-, 60,- and 90-day time intervals. Mean age ranged from 57.62 to 57.64 years in group 1 and from 61.96 to 62 years in group 2. Overall, there was a trend toward patients ranging in the age group 65 to 79 years in both groups. Further patient characteristics are outlined in Table 1.
Table 1.
Patient characteristics for biliary-stent and no-stent groups in patients with cholelithiasis and choledocholithiasis after ERCP and biliary sphincterotomy on index admission in the United States from 2016 to 2020
| Index population for 30-day readmissions |
Index population for 60-day readmissions |
Index population for 90-day readmissions |
||||
|---|---|---|---|---|---|---|
| No biliary stent placement | Biliary stenting | No biliary stent placement | Biliary stenting | No biliary stent placement | Biliary stenting | |
| Total no. of hospitalizations | 176,575 | 60,111 | 160,707 | 54,711 | 144,207 | 49,065 |
| Age, y | 57.64 ± 0.20 | 61.96 ± .29 | 57.64 ± .20 | 62 ± .30 | 57.62 ± 0.21 | 61.96 ± .32 |
| Age groups, y | ||||||
| 18-34 | 34,663 (19.69) | 7916 (13.23) | 31,533 (19.68) | 7168 (13.16) | 28,307 (19.6) | 6489 (13.29) |
| 35-49 | 28,036 (15.92) | 7921 (13.24) | 25,632 (15.99) | 7198 (13.22) | 23,028 (16.01) | 6396 (13.10) |
| 50-64 | 36,368 (20.66) | 12,941 (21.63) | 33,060 (20.63) | 11,778 (21.63) | 29,707 (20.66) | 10,612 (21.73) |
| 65-79 | 45,783 (26) | 17,936 (29.9) | 41,558 (25.93) | 16,352 (30.03) | 37,203 (25.87) | 14,677 (30) |
| ≥80 | 31,179 (17.71) | 13,090 (21.88) | 28,427 (17.74) | 11,939 (21.93) | 25,516 (17.74) | 10,645 (21.8) |
| Charlson comorbidity index | ||||||
| 0 | 86,828 (49.32) | 25,490 (42.62) | 79,124 (49.38) | 23,141 (42.51) | 71,067 (49.43) | 20,853 (42.71) |
| 1 | 42,015 (23.86) | 14,949 (24.99) | 38,320 (23.91) | 13,628 (25.03) | 34,397 (23.92) | 12,262 (25.11) |
| 2 | 19,954 (11.33) | 7729 (12.92) | 18,127 (11.31) | 7086 (13.01) | 16,291 (11.33) | 6323 (12.95) |
| Charlson comorbidity index ≥3 | 27,231 (15.46) | 11,638 (19.45) | 24,640 (15.37) | 10,580 (19.43) | 220,006 (15.3) | 9281 (19.21) |
| Hospital region | ||||||
| Metropolitan | 170,621 (96.92) | 57,994 (96.97) | 155,316 (96.94) | 52,801 (96.99) | 139,389 (96.95) | 47,329 (96.94) |
| Micropolitan | 4940 (2.8) | 1655 (2.76) | 4476 (2.79) | 1488 (2.73) | 3999 (2.78) | 1356 (2.77) |
| Nonubran | 469 (.26) | 157 (.26) | 420 (.26) | 146 (.26) | 375 (.26) | 133 (.27) |
| Hospital size (by beds) | ||||||
| Small | 27,148 (15.42) | 8218 (13.74) | 24,647 (15.38) | 7493 (13.76) | 22,174 (15.42) | 6788 (13.90) |
| Medium | 48,767 (27.7) | 15,005 (25.08) | 44,396 (27.71) | 13,657 (25.08) | 93,840 (27.71) | 12,239 (25.06) |
| Large | 100,115 (56.87) | 36,528 (61.16) | 91,168 (56.9) | 33,285 (38.85) | 81,748 (56.86) | 29,792 (61.02) |
| Discharge type | ||||||
| Routine (home) | 150,591 (85.54) | 48,140 (80.49) | 137,052 (85.54) | 43,804 (80.46) | 122,971 (85.53) | 39,405 (80.71) |
| Transfer to short-term hospital | 508 (.28) | 289 (.48) | 447 (.27) | 260 (.47) | 410 (.28) | 234 (.47) |
| Transfer to another facility | 10,163 (5.77) | 4805 (8) | 9318 (5.81) | 4380 (8.04) | 8394 (5.83) | 3873 (7.93) |
| Home health care | 13,279 (7.54) | 5974 (9.98) | 12,056 (7.52) | 5472 (10.05) | 10,803 (7.51) | 4861 (9.95) |
| Discharge against medical advice | 905 (0.51) | 288 (.48) | 821 (0.51) | 258 (.47) | 726 (.5) | 226 (.46) |
| Insurance | ||||||
| Medicare | 77,765 (44.17) | 31,252 (52.25) | 70,772 (44.17) | 28,514 (52.38) | 63,424 (44.11) | 25,485 (52.20) |
| Medicaid | 28,410 (16.13) | 8260 (13.81) | 25,860 (16.14) | 7479 (13.73) | 23,299 (16.20) | 6756 (13.84) |
| Private insurance | 55,647 (31.61) | 16,117 (26.95) | 50,630 (31.6) | 14,671 (26.95) | 45,416 (61.59) | 13,197 (27.03) |
| Self-pay | 8328 (4.73) | 2444 (4.08) | 7579 (4.73) | 2241 (4.11) | 6871 (4.77) | 2021 (4.14) |
Values are mean ± SE or n (%).
30-day readmission rates
Overall, the risk of 30-day readmission for all biliary events was higher in group 2 (1.18% vs .67%; aHR, 1.78, 95% confidence interval [CI], 1.55-2.04, P value < .001) than in group 1 (Table 2). These patients also had higher risk of readmissions for choledocholithiasis (0.39% vs 0.25%; aHR, 1.65; 95% CI, 1.31-2.07; P < .001), cholecystitis (.49% vs .3%; aHR, 1.64; 95% CI, 1.34-2; P < .001), cholangitis (.15% vs .06%; aHR, 2.36; 95% CI, 1.6-3.49; P < .001), and gallstone pancreatitis (.13% vs .05%; aHR, 2.35; 95% CI, 1.51-3.67; P < .001) compared with group 1.
Table 2.
Comparison of risk of readmission between biliary-stent and no-stent groups in patients with cholelithiasis and choledocholithiasis after ERCP and biliary sphincterotomy on index admission
| No biliary stent placement | Biliary stenting | Adjusted HR | 95% CI | P value | |
|---|---|---|---|---|---|
| 30-day readmission | |||||
| All biliary events | 1191 (.67) | 706 (1.18) | 1.78 | 1.55-2.04 | <.001 |
| Choledocholithiasis | 445 (.25) | 238 (.39) | 1.65 | 1.31-2.07 | <.001 |
| Cholecystitis | 528 (.3) | 296 (.49) | 1.64 | 1.34-2.0 | <.001 |
| Cholangitis | 114 (.06) | 93 (.15) | 2.36 | 1.6-3.49 | <.001 |
| Gallstone pancreatitis | 103 (.05) | 79 (.13) | 2.35 | 1.51-3.67 | <.001 |
| 60-day readmission | |||||
| All biliary events | 1671 (1.04) | 1151 (2.12) | 2.04 | 1.82-2.28 | <.001 |
| Choledocholithiasis | 576 (.35) | 349 (.64) | 1.85 | 1.53-2.23 | <.001 |
| Cholecystitis | 829 (.51) | 529 (.97) | 1.83 | 1.56-2.14 | <.001 |
| Cholangitis | 157 (.09) | 179 (.32) | 3.31 | 2.4-4.57 | <.001 |
| Gallstone pancreatitis | 109 (.06) | 94 (.17) | 2.68 | 1.77-4.04 | <.001 |
| 90-day readmission | |||||
| All biliary events | 1832 (1.27) | 1294 (2.66) | 2.07 | 1.86-2.30 | <.001 |
| Choledocholithiasis | 609 (.42) | 394 (.8) | 1.92 | 1.61-2.30 | <.001 |
| Cholecystitis | 932 (.64) | 617 (1.26) | 1.9 | 1.64-2.2 | <.001 |
| Cholangitis | 187 (.12) | 188 (.38) | 2.89 | 2.13-3.92 | <.001 |
| Gallstone pancreatitis | 104 (.07) | 94 (.19) | 2.78 | 1.83-4.23 | <.001 |
CI, Confidence interval; HR, hazard ratio.
60-day readmission rates
The risk of 60-day readmission for all biliary events was higher in group 2 (2.12% vs 1.04%; aHR, 2.04; 95% CI, 1.82-2.28; P < .001) than in group 1 (Table 2). Furthermore, after index admission, patients in Group 2 had higher risk of readmission for choledocholithiasis (.64% vs .35%; aHR, 1.85; 95% CI, 1.53-2.23; P < .001), cholecystitis (.97% vs .51%; aHR, 1.83; 95% CI, 1.56-2.14; P < .001), cholangitis (.32% vs .09%; aHR, 3.31; 95% CI, 2.4-4.57; P < .001), and gallstone pancreatitis (.17% vs .06%; aHR, 2.68; 95% CI, 1.77-4.04; P < .001) compared with Group 1.
90-day readmission rates
For 90-day readmissions, the overall risk of readmission for all biliary events was higher for group 2 patients (2.66% vs 1.27%; aHR, 2.07; 95% CI, 1.86-2.30; P < .001) than for group 1 (Table 2). Similarly, after index admission, patients in group 2 had higher readmission rates for choledocholithiasis (.8% vs .42%; aHR, 1.92; 95% CI, 1.61-2.30; P < .001), cholecystitis (1.26% vs .64%; aHR, 1.9; 95% CI, 1.64-2.2; P < .001), cholangitis (.38% vs .12%; aHR, 2.89; 95% CI, 2.13-3.92; P < .001), and gallstone pancreatitis (.19% vs .07%; aHR, 2.78; 95% CI, 1.83-4.23; P < .001) compared with group 1.
Health care burden in the United States
Patients in group 2 had longer mean LOS for 30-day (4.04 vs 2.93 days; difference on regression, 1.04; 95% CI, .4-1.68; P = .001), 60-day (3.92 vs 2.99 days; difference on regression, .80; 95% CI, .16-1.44; P = .013), and 90-day (3.78 vs 3.02 days, difference on regression 0.66; 95% CI, .096-1.24; P = .022) readmissions compared with patients in group 1 (Table 3).
Table 3.
Comparison of length of stay and total hospitalization charges at 30-, 60-, and 90-day readmissions between biliary-stent and no-stent groups in patients with cholelithiasis and choledocholithiasis after ERCP and biliary sphincterotomy on index admission
| 30-day readmission |
60-day readmission |
90-day readmission |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| No biliary stent placement | Biliary stent | Difference on regression (95% CI), P value | No stent | Stent | Difference on regression (95% CI), P value | No stent | Stent | Difference on regression (95% CI), P value | |
| Length of stay, d | 2.93 | 4.04 | 1.04 (.4-1.68), .001 | 2.99 | 3.92 | .80 (.16-1.44), .013 | 3.02 | 3.78 | .66 (.096-1.24), .022 |
| Total hospitalization charges , $ | 45,838 | 60,175 | 12,938 (3891-21,985), .005 | 46,649 | 59,536 | 10,901 (3008-18,793), .007 | 47,734 | 57,904 | 8349 (1141-15,556), .023 |
CI, Confidence interval.
From a cost perspective, group 2 patients had a higher mean THC for 30-day ($60,175 vs $45,838; difference on regression, $12,938; 95% CI, $3891-$21,985; P = .005), 60-day ($59,536 vs $46,649; difference on regression, $10,901; 95% CI, $3008-$18,793; P = .007), and 90-day ($57,904 vs $47,734; difference on regression, $8349; 95% CI, $1141-$15,556; P = .023) readmissions compared with patients in group 1 (Table 3).
Post-ERCP pancreatitis
After adjusting for all possible confounders, including hospitalization characteristics, hospital characteristics, and patient comorbidities, group 2 patients had higher rates of readmission for PEP within the first 48 hours after hospital discharge (.05% vs .03%; adjusted odds ratio [aOR], 1.93; 95% CI, 1.05-3.52; P = .032) compared with group 1 patients (Table 4). However, we did not find a statistical difference in the rates of PEP from 48 hours to 7 days after hospital discharge between the groups (.8% vs .05%; aOR, 1.54; 95% CI, .95-2.49; P = .079).
Table 4.
Comparison of post-ERCP pancreatitis on readmission between biliary-stent and no stent groups in patients with cholelithiasis and choledocholithiasis after ERCP and biliary sphincterotomy on index admission
| Post-ERCP pancreatitis | No biliary stent placement | Biliary stent | aOR (95% CI) | P value |
|---|---|---|---|---|
| Readmission within 48 h after discharge | 68 (.03) | 37 (.05) | 1.93 (1.05-3.52) | .032 |
| Readmission 48 h to 7 d after discharge | 103 (.05) | 54 (.08) | 1.54 (.95-2.49) | .079 |
Values are n (%).
aOR, Adjusted odds ratio; CI, confidence interval.
Discussion
Our analysis shows that among patients with cholelithiasis and choledocholithiasis, prophylactic biliary stenting in addition to endoscopic biliary sphincterotomy does not offer any additional protection against gallstone-related adverse events while awaiting cholecystectomy. We found higher 30-, 60-, and 90-day readmission rates for adverse events including acute cholecystitis, cholangitis, choledocholithiasis, and gallstone pancreatitis, as well as longer LOS among patients who received a biliary stent compared with those who did not.
Gallstone disease has a high worldwide prevalence, and 10% to 20% of patients with choledocholithiasis may develop adverse events, including gallstone pancreatitis and cholangitis. Patients with combined cholelithiasis and choledocholithiasis require treatment for both biliary obstruction and gallbladder stones.18, 19, 20 Therapeutic ERCP for choledocholithiasis may be performed before, during, or after cholecystectomy.21, 22, 23 Patients with a low probability of choledocholithiasis are generally recommended to have cholecystectomy, with or without an intraoperative cholangiogram, with selective postoperative ERCP, whereas those with a high probability are recommended to have ERCP first, followed by cholecystectomy.24, 25, 26, 27
In modern clinical practice, biliary stenting after EST and bile duct clearance is often performed, particularly in patients with ascending cholangitis, with difficult choledocholithiasis or cystic duct stones, or in whom it is thought that more stones are likely to pass into the common bile duct before cholecystectomy can be performed, to prevent occurrence of biliary adverse events in the time interval to cholecystectomy.16 In addition, if a delay in cholecystectomy is anticipated, biliary stenting is often performed to guarantee patency of the bile duct.
However, in the absence of compelling indications, the role of prophylactic biliary stent after EST and stone clearance, especially among patients with cholelithiasis and choledocholithiasis, is not fully clear, with some studies favoring28,29 and others showing no benefit of biliary stenting.30 A retrospective case-control study of patients with choledochocystolithiasis who underwent EST with or without prophylactic common bile duct stent insertion before cholecystectomy found that biliary stent placement had no significant impact on biliary adverse events.17 Similarly, a more recent retrospective analysis of 136 patients31 and a randomized controlled trial of 70 patients reported similar findings.32 In addition, the latter reported higher rates of adverse events in the stent group, with 2 patients developing cholecystitis and 3 developing PEP, compared with no adverse events in the no-stent group. Our findings are in line with these observations, that patients in the stent group had higher incidence of cholelithiasis, choledocholithiasis, cholecystitis, cholangitis, or gallstone pancreatitis compared with the no-stent group.
The utility of biliary stenting and its effect on outcomes of cholecystectomy also have been explored. A study by Nair et al33 suggested that the placement of a bile duct stent for 6 weeks duration before elective laparoscopic cholecystectomy affected the operation time, conversion rate, bile leak rate, and LOS. In contrast, Lee et al34 reported there were no surgical adverse events regardless of whether biliary stenting was performed, and that the insertion of a stent was not a predictor of conversion to open cholecystectomy or a long operative time. Although we were unable to assess for peri- or postprocedural adverse events in our cohort of patients, we did note a trend toward longer lengths of hospital stay and higher total health care costs at 90 days among the stented cohort of patients.
Our analysis has several notable strengths. First, our inclusion and exclusion criteria were well defined, which allowed us to capture all patients from the readmissions database without any cohort overlap. Second, we assessed outcomes at 3 different time intervals after the index ERCP, from 30 to 90 days. This was done to take into account the variability of time interval to cholecystectomy that is often seen in clinical practice. We assessed readmissions compositely for most common biliary adverse events, including cholecystitis, choledocholithiasis, cholangitis, and gallstone pancreatitis, as well as each of these individually. We also assessed outcomes of PEP among both cohorts of patients. Finally, in addition to assessing biliary adverse events among patients with cholelithiasis and choledocholithiasis, we also analyzed the LOS and total health care costs, which are important to consider when analyzing health care cost burden among these patients.
However, although our study findings are aligned with recent studies on this topic, the results must be viewed in light of several limitations, most of which are inherent to any retrospective database analysis. First, although we accounted for both cohorts of patients undergoing biliary sphincterotomy, we were unable to assess and perform propensity score matching for additional factors such as age, sex, common bile duct diameter, and number of bile duct stones. Second, procedure-related data, including endoscopic papillary balloon dilation, use of precut or needle knife fistulotomy for difficult biliary cannulation, whether use cholangioscopy with electrohydraulic lithotripsy was needed for clearance of stone and type (plastic or metallic), as well as size and length of stent used, were not available for further analysis. In addition, the ICD-10 codes used for capturing patients who underwent ERCP with stent placement do not further categorize into biliary versus pancreatic duct stent placement.
Third, there was no definitive and conclusive way to assess if complete bile duct clearance was achieved in both cohorts of patients, because individual procedure reports were not available for review. Fourth, the NRD lacks data on hospitalization course and etiology of LOS and adverse events noted in the study. In addition, it is unknown how many patients had evidence of purulent bile or cystic duct stones at the time of the ERCP, factors that could influence the decision of whether or not to place a biliary stent. It is important to consider that higher readmission risk, LOS, THC, and PEP within 48 hours after discharge among patients with biliary stenting may be due to technical difficulties encountered during the procedure or presence of large stones resulting in incomplete ductal clearance thereby necessitating placement of a biliary stent. Similarly, higher readmission rates could be due to incomplete common bile duct clearance at the index procedure. Because patients who underwent cholecystectomy within 2 weeks after discharge and index ERCP were excluded, the role of prophylactic biliary stenting and incidence of PEP in this subset of patients remains unclear. Finally, the retrospective nature of the study, use of ICD-10 codes to capture patient data, concern for misdiagnosis, underreporting of some variables, and incorrect diagnosis entry likely resulted in selection bias.
In conclusion, our analysis found that prophylactic biliary stenting in addition to biliary sphincterotomy may not offer any additional advantage in preventing biliary adverse events among patients with cholelithiasis and choledocholithiasis in the time interval to cholecystectomy. It is important to recognize that biliary stent placement may still be indicated among patients with a variety of findings seen at ERCP, including ascending cholangitis, Mirrizi syndrome, and difficult choledocholithiasis, or if a delay in cholecystectomy is anticipated or further stone passage from the gallbladder to the common bile duct is thought to be likely, among others. Further well designed randomized controlled trials are warranted to validate our findings.
Ethical Statement
The NRD is publicly available and lacks patient- and hospital-specific identifiers. Therefore, institutional review board (IRB) approval was not required according to guidelines put forth by our IRB for analysis of national databases.
Disclosure
All authors disclosed no financial relationships.
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