Endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound with fine needle aspiration (EUS-FNA) are useful techniques for a variety of pancreaticobiliary disorders. Despite their benefit, both procedures carry potential adverse events (AE), which may lead to substantial morbidity and mortality [
The aim of this study was to evaluate the 30-day AE of inpatient versus ASC ERCP or EUS in a multicenter, prospective cohort in high-risk subjects. We evaluated the epidemiologic and procedural risk factors for AE, as well as costs related to these procedures. Our hypothesis was that there would be no significant difference in 30-day AE when comparing the inpatient group with the ASC group.
This prospective multicenter study was approved by our Institutional Review Board (IRB 14-046EX) and was performed in accordance with the Declaration of Helsinki. From June 2014 until November 2014, we prospectively enrolled consecutive subjects from three medical centers (one tertiary care center (Cooper University Hospital), two community centers (Our Lady of Lourdes Medical Center in Camden and Burlington, New Jersey) (NJ)), their subsequent ASCs (1 tertiary care endoscopy unit (Cooper University Hospital Digestive Health Institute in Mount Laurel, NJ), and 2 community-based units (Our Lady of Lourdes Medical center in Camden and Burlington, NJ)). The ASC for Cooper University Hospital was located 10 miles from its tertiary care center and the ASCs for Our Lady of Lourdes were located 1 mile away from each community hospital location. All advanced endoscopy rooms were staffed with 2 skilled endoscopy nurses and 1 skilled endoscopy technician. Informed consent was obtained from all participants for our study and no substituted consent was used.
Both men and women ≥ 18 years of age were included in this study. All subjects were undergoing ERCP and/or EUS for various indications. Inpatients and ASC subjects who completed all data points and follow-up were included. We excluded pregnant women and subjects with missing data from this study.
Demographic data was then obtained from all participants and included age, sex, ethnicity, relevant comorbid conditions (i.e., cardiovascular disease (acute coronary syndrome, stroke, and systolic congestive heart failure with ejection fraction under 45%), pulmonary disease (obstructive sleep apnea, chronic obstructive pulmonary disease, etc.), cirrhosis, end-stage renal disease on dialysis), and surgical history (i.e., endoscopic interventions). A medication history was obtained to evaluate the use of anticoagulants and antiplatelet agents at the time of advanced endoscopy. All subjects received baseline liver enzymes, an amylase, and lipase to determine whether pancreatitis was present prior to the procedure [
Subjects were deemed to be at high risk by standard criterion (see supplemental appendix 1 in Supplementary Material available online at
On the day of the examination, the indication(s) for the intervention were recorded. Then, assessment of ASA class and Mallampati score were evaluated using standard means (defined in supplemental appendix 3) [
At time zero, subjects were prospectively enrolled and given study identification using a random number generator. Prior to their procedure, an anesthesiologist determined the location of their ERCP/EUS based upon this randomization.
Three endoscopists participated in this study, all of whom had >5 years of endoscopy experience and have performed over 200 ERCPs and EUSs per year. Two postgraduate year 6 (PGY-6) fellows participated in all endoscopies performed at our tertiary care setting.
Anesthesia was administered using propofol-based monitored anesthesia care (MAC) for the duration of the procedure. No rectal indomethacin was used as prophylaxis during the study as was not the standard practice at our center during enrollment.
Presence of any AE was the primary outcome and each of the individual AE was among the secondary outcomes. AE were defined by the presence of any of the following: fever, worsening abdominal pain (based upon Likert score), gastrointestinal bleeding (GIB), infection, perforation, aspiration, need for intubation, cardiovascular arrest, acute coronary syndrome (ACS), arrhythmia, surgery, admission (if so, reason for admission, length of stay, and cost of stay), service call (if so, reason and number of calls), systemic inflammatory response syndrome (SIRS), sepsis, infection, multiorgan failure (MOF), and death (reason). Additional AE included the presence of post-ERCP pancreatitis (PEP) (see supplemental appendix 5), defined by the presence of (1) new or worsening abdominal pain that is clinically consistent with acute pancreatitis and (2) associated pancreatic enzymes elevation ≥ 3 times the upper limit of normal twenty-four hours after the procedure and (3) resultant or prolongation of existing hospitalization of ≥2 nights. Other secondary outcomes included the cost of each procedure along with subsequent AE-related costs (i.e., hospital admission and surgery) obtained using insurance data.
In order to monitor for these outcomes, data were obtained intraprocedurally and postprocedurally, as well as 1 and 30 days after endoscopy. During the procedure, hemodynamic measurements and endoscopic interventions were recorded (i.e., sphincterotomy and FNA). After their procedure, subjects were then brought to the recovery room and monitored in standard fashion. Once conscious, the ten-point pain assessment scale was again assessed. If there was a concern for AE, the subjects underwent hemodynamic monitoring and intravenous fluid (IVF) resuscitation with 1-2 liters of crystalloid and the endoscopist was then able to admit the subject to our institution if needed. If admitted, all subjects underwent basic lab work (chemistry, blood count, amylase, lipase, and liver function testing), as well as abdominal imaging if required.
To evaluate delayed complications, subjects were encouraged to return to the institution in which their procedure was performed. For comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours or 30 days from their procedure.
We determined 292 subjects would reach statistical significance. This is assuming 12% AE for ERCP and 3% for EUS with 5% risk of producing an alpha error to obtain 80% power.
Group and treatment comparisons were carried out using Fisher’s exact test for categorical variables and ANOVA with contrasts for continuous variables. Outcomes were evaluated using single variable logistic regression with odds ratios and 99% confidence intervals. A
From June 2014 until November 2014, a total of 562 ERCP and EUS subjects were screened for study participation. Of those eligible for study participation, 375 agreed to participate in our study and were subsequently analyzed. Among this study sample, 98 procedures were inpatients and 277 were ASC subjects. Of these procedures, 76 were ERCP alone and 22 EUS alone were inpatients, while 160 ERCP and 117 EUS were ASC subjects (see our study schema, Figure
Study schema with group distribution and number/reason for exclusion in the study.
Demographic and comorbid condition data did not demonstrate statistical significance between inpatients and ASC subjects (see Table
Demographic and risk data for inpatient versus ASC ERCP, EUS, and the total population.
ERCP | EUS | Total | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
IN | ASC | ALL | | IN | ASC | All | | IN | ASC | ALL | | |
Total cases | 76 | 160 | 236 | 22 | 117 | 139 | 98 | 277 | 375 | |||
Mean age (years) | 61.8 | 60.2 | 62 | 0.54 | 64.2 | 67.6 | 63.5 | 0.62 | 62.7 | 63.8 | 63.5 | 0.85 |
Sex | ||||||||||||
Male | 31 (41%) | 46 (29%) | 77 (33%) | 0.17 | 18 (82%) | 56 (48%) | 74 (53%) | 0.13 | 49 (50%) | 102 (37%) | 151 (40%) | 0.1 |
Female | 45 (59%) | 114 (71%) | 159 (67%) | 4 (18%) | 61 (52%) | 65 (47%) | 49 (50%) | 175 (63%) | 224 (60%) | |||
Comorbid conditions | ||||||||||||
Cardiovascular disease | 35 (46%) | 55 (34%) | 90 (38%) | 0.12 | 4 (18%) | 57 (49%) | 61 (44%) | 0.22 | 39 (40%) | 112 (40%) | 151 (40%) | 0.27 |
Pulmonary disease | 17 (22%) | 18 (11%) | 35 (15%) | 0.04 | 2 (9%) | 17 (15%) | 19 (14%) | 0.53 | 19 (19%) | 35 (13%) | 54 (14%) | 0.97 |
ESRD on dialysis | 12 (16%) | 27 (17%) | 39 (17%) | 0.70 | 1 (5%) | 31 (27%) | 32 (23%) | 0.28 | 16 (16%) | 62 (22%) | 78 (21%) | 0.03 |
Cirrhosis | 5 (7%) | 7 (4%) | 12 (5%) | 0.53 | 0 | 5 (4%) | 5 (4%) | 0.99 | 5 (5%) | 13 (5%) | 18 (5%) | 0.98 |
Medications | ||||||||||||
Anticoagulation | 3 (4%) | 6 (4%) | 9 (4%) | 1.00 | 1 (5%) | 4 (3%) | 5 (4%) | 0.28 | 4 (4%) | 10 (4%) | 14 (4%) | 0.55 |
Antiplatelet agent | 16 (21%) | 23 (14%) | 39 (17%) | 0.25 | 1 (5%) | 25 (2%) | 26 (19%) | 0.43 | 17 (17%) | 48 (17%) | 65 (17%) | 0.07 |
Endoscopic risk factors | ||||||||||||
High risk features | 17 (22%) | 69 (43%) | 86 (36%) | 0.09 | 0 | 6 (5%) | 6 (4%) | 0.99 | 17 (17%) | 75 (27%) | 92 (25%) | 0.1 |
History of SOD | 4 (5%) | 19 (12%) | 23 (10%) | 0.09 | 0 | 6 (5%) | 6 (4%) | 1.00 | 4 (4%) | 25 (7%) | 29 (6%) | 0.72 |
History of post-ERCP pancreatitis | 0 | 0 | 0 | 1.00 | 0 | 0 | 0 | 1.00 | 0 | 0 | 0 | 1.00 |
Pancreatic sphincterotomy | 7 (9%) | 37 (23%) | 44 (19%) | 0.03 | NA | 1.00 | 7 (7%) | 37 (13%) | 44 (12%) | 0.01 | ||
Precut sphincterotomy | 1 (1%) | 1 (1%) | 2 (1%) | 0.62 | NA | 1.00 | 1 (1%) | 1 (1%) | 2 (1%) | 1.00 | ||
>8 cannulation attempts | 0 | 0 | 0 | 1.00 | NA | 1.00 | 0 | 0 | 0 | 1.00 | ||
Pneumatic dilation of an intact biliary sphincter | 5 (7%) | 9 (6%) | 14 (6%) | 0.84 | NA | 1.00 | 5 (5%) | 9 (3%) | 14 (4%) | 1.00 | ||
Ampullectomy | 0 | 3 (2%) | 3 (1%) | 0.95 | NA | 1.00 | 0 | 3 (1.1%) | 3 (0.8%) | 1.00 | ||
Moderate risk features | 19 (25%) | 68 (43%) | 87 (37%) | 0.10 | 0 | 7 (6%) | 7 (5%) | 0.98 | 19 (19%) | 75 (27%) | 94 (25%) | 0.02 |
Age < 50 and female | 9 (12%) | 26 (16%) | 35 (15%) | 0.29 | 0 | 3 (3%) | 3 (2%) | 0.99 | 9 (9%) | 29 (11%) | 38 (10%) | 0.09 |
History of recurrent pancreatitis | 6 (8%) | 7 (4%) | 13 (6%) | 0.38 | 0 | 4 (3%) | 4 (3%) | 0.99 | 6 (6%) | 11 (4%) | 17 (5%) | 0.93 |
>3 injections to PD, 1 to tail | 1 (1%) | 11 (7%) | 12 (5%) | 1.00 | NA | 1.00 | 1 (1%) | 11 (4%) | 12 (3%) | 1.00 | ||
Excessive injection PD contrast, leading to acini | 0 | 0 | 0 | 1.00 | NA | 1.00 | 0 | 0 | 0 | 1.00 | ||
Acquisition of cytology from PD using brush | 3 (4%) | 5 (3%) | 8 (3%) | 0.30 | NA | 1.00 | 3 (3%) | 5 (2%) | 8 (2%) | 0.30 | ||
Anesthesia risk | ||||||||||||
Mean Mallampati score | 1.7 | 1.4 | 1.5 | 0.09 | 1.6 | 1.5 | 1.5 | 0.93 | 1.7 | 1.5 | 1.5 | 0.02 |
Mean ASA score | 2.8 | 2.3 | 2.5 | 0.12 | 2.8 | 2.6 | 2.6 | 0.38 | 2.8 | 2.4 | 2.5 | 0.24 |
1 | 2 (3%) | 17 (11%) | 19 (8%) | 0 | 1 (1%) | 1 (1%) | 2 (2%) | 18 (7%) | 20 (5%) | |||
2 | 17 (22%) | 74 (46%) | 91 (39%) | 4 (18%) | 45 (39%) | 49 (35%) | 21 (21%) | 119 (43%) | 140 (37%) | |||
3 | 52 (68%) | 69 (43%) | 121 (51%) | 18 (82%) | 71 (61%) | 89 (64%) | 70 (71%) | 140 (51%) | 210 (56%) | |||
4 | 5 (7%) | 0 | 5 (2%) | 0 | 0 | 0 | 5 (5%) | 0 | 5 (1%) |
ERCP: endoscopic retrograde cholangiopancreatography; EUS: endoscopic ultrasound; IN: inpatients; ASC: ambulatory surgical center patients; ALL: inpatients + ASC patients; CI: confidence interval; ESRD: end-stage renal disease; SOD: sphincter of Oddi dysfunction; PD: pancreatic duct; ASA: American society of anesthesia class.
Preprocedural risk factors, namely, “high-risk” components, were slightly variable among inpatients versus ASC ERCPs (22.3% versus 43.1%, resp.,
Among the inpatients versus ASC groups that underwent both ERCP and EUS, there were no significant differences in the indication. All indications can be summarized in Table
Indications, findings, and interventions for inpatient versus ASC ERCP, EUS, and the total population.
ERCP | EUS | Total | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
IN | ASC | ALL | | IN | ASC | ALL | | IN | ASC | ALL | | |
| ||||||||||||
Biliary | ||||||||||||
Obstructive jaundice | 39 (51%) | 37 (23%) | 76 (32%) | | 10 (46%) | 8 (7%) | 18 (13%) | 0.07 | 49 (50%) | 45 (16%) | 94 (25%) | |
SOD | 24 (32%) | 40 (25%) | 64 (27%) | 0.02 | 3 (14%) | 8 (7%) | 11 (8%) | 0.98 | 27 (28%) | 48 (17%) | 75 (20%) | 0.02 |
Dilated biliary ductal system | 31 (41%) | 25 (16%) | 56 (24%) | | 4 (18%) | 5 (4%) | 9 (7%) | 0.94 | 35 (36%) | 30 (11%) | 65 (17%) | |
Choledocholithiasis | 19 (25%) | 22 (14%) | 41 (17%) | 0.046 | 0 | 0 | 0 | 1.00 | 19 (19%) | 22 (8%) | 41 (11%) | 0.55 |
Elevated LFT | 17 (20%) | 5 (3%) | 22 (9%) | | 3 (14%) | 1 (1%) | 4 (3%) | 1.00 | 20 (20%) | 6 (2%) | 26 (7%) | |
Cholangitis | 9 (12%) | 0 | 9 (4%) | 0.92 | 0 | 0 | 0 | 1.00 | 9 (9%) | 10 (3%) | 9 (2%) | 1.00 |
Biliary stricture | 3 (4%) | 8 (5%) | 11 (5%) | 0.37 | 1 (5%) | 1 (1%) | 2 (1%) | 0.99 | 4 (4%) | 9 (3%) | 13 (4%) | 0.62 |
Stent extraction | 9 (12%) | 28 (18%) | 37 (16%) | 0.12 | 1 (5%) | 0 | 1 (1%) | 0.99 | 10 (10%) | 28 (10%) | 38 (10%) | 0.03 |
Bile leak | 10 (13%) | 14 (9%) | 24 (10%) | 0.53 | 1 (5%) | 0 | 1 (1%) | 0.98 | 11 (11%) | 14 (5%) | 25 (7%) | 0.35 |
Pancreatic | ||||||||||||
Pancreatic mass | 8 (11%) | 10 (6%) | 18 (8%) | 0.09 | 6 (27%) | 26 (22%) | 32 (23%) | 0.19 | 14 (14%) | 36 (13%) | 50 (13%) | |
Pancreatic cyst | 0 | 6 (4%) | 6 (3%) | 0.96 | 1 (5%) | 38 (33%) | 39 (28%) | 0.22 | 1 (1%) | 44 (16%) | 45 (12%) | |
Chronic pancreatitis | 2 (3%) | 16 (10%) | 18 (8%) | 0.11 | 1 (5%) | 8 (7%) | 9 (7%) | 0.37 | 3 (3%) | 24 (9%) | 27 (7%) | 0.48 |
Gall stone pancreatitis | 11 (15%) | 1 (1%) | 12 (5%) | | 3 (14%) | 3 (3%) | 6 (3%) | 0.02 | 14 (14%) | 4 (1%) | 18 (5%) | |
Pancreatic divisum | 1 (1%) | 10 (6%) | 11 (5%) | 0.11 | 0 | 2 (2%) | 2 (1%) | 0.99 | 1 (1%) | 14 (5%) | 15 (4%) | 0.44 |
Neoplastic | ||||||||||||
Any neoplasm | 11 (15%) | 12 (8%) | 23 (10%) | 0.10 | 3 (14%) | 29 (25%) | 32 (23%) | 0.61 | 21 (21%) | 44 (16%) | 65 (17%) | |
Palliation neoplasm | 5 (7%) | 1 (1%) | 6 (3%) | 0.06 | 2 (9%) | 0 | 2 (1%) | 1.00 | 7 (7%) | 1 (1%) | 8 (2%) | 0.50 |
Staging of neoplasm | 6 (8%) | 6 (4%) | 12 (5%) | 0.68 | 5 (23%) | 46 (39%) | 51 (37%) | 0.98 | 11 (11%) | 52 (19%) | 63 (17%) | |
Generalized | ||||||||||||
Chronic abdominal pain | 8 (11%) | 53 (33%) | 61 (26%) | | 0 | 6 (5%) | 6 (3%) | 0.99 | 8 (8%) | 59 (21%) | 67 (18%) | |
| ||||||||||||
ERCP | ||||||||||||
Biliary | ||||||||||||
EBS | 57 (75%) | 108 (68%) | 165 (70%) | | NA | 1.00 | 57 (58%) | 108 (39%) | 165 (44%) | | ||
Needle knife | 1 (1%) | 1 (1%) | 2 (1%) | 1.00 | NA | 1.00 | 1 (1%) | 1 (1%) | 2 (1%) | 1.00 | ||
SEMS | 12 (16%) | 5 (3%) | 17 (8%) | 0.06 | NA | 1.00 | 12 (12%) | 5 (2%) | 17 (5%) | 0.06 | ||
Plastic stent | 23 (30%) | 18 (11%) | 41 (17%) | | NA | 1.00 | 23 (24%) | 18 (7%) | 41 (11%) | | ||
Cytology | 11 (15%) | 22 (14%) | 33 (14%) | | NA | 1.00 | 11 (1%) | 22 (8%) | 33 (9%) | | ||
Cholangioscopy | 4 (5%) | 11 (7%) | 15 (11%) | 0.40 | NA | 1.00 | 4 (4%) | 11 (4%) | 15 (4%) | 0.40 | ||
Manometry | 2 (3%) | 18 (11%) | 20 (9%) | 0.47 | NA | 1.00 | 2 (2%) | 18 (7%) | 20 (5%) | 0.47 | ||
Pancreatic | ||||||||||||
EPS | 6 (8%) | 30 (19%) | 36 (15%) | 0.03 | NA | 1.00 | 6 (6%) | 30 (11%) | 36 (10%) | 0.03 | ||
Minor duct papillotomy | 1 (1%) | 8 (5%) | 9 (4%) | 0.92 | NA | 1.00 | 1 (1%) | 8 (3%) | 9 (2%) | 0.92 | ||
PD Stent | 21 (28%) | 44 (28%) | 65 (28%) | 1.00 | NA | 1.00 | 21 (21%) | 44 (16%) | 65 (17%) | 0.60 | ||
Ampullary biopsy | 2 (3%) | 13 (8%) | 15 (6%) | 0.13 | 0 | 1 (1%) | 1 (1%) | 1.00 | 3 (3%) | 14 (5%) | 17 (5%) | 0.81 |
EUS | ||||||||||||
FNA | NA | 1.00 | 12 (55%) | 77 (66%) | 89 (64%) | | 12 (12%) | 77 (28%) | 89 (24%) | |
ERCP: endoscopic retrograde cholangiopancreatography; EUS: endoscopic ultrasound; IN: inpatients; ASC: ambulatory surgical center patients; ALL: inpatients + ASC patients; GI: gastrointestinal; LFT: liver function tests; SOD: sphincter of Oddi dysfunction; GIST: gastrointestinal stromal tumor; IPMN: intraductal papillary mucinous neoplasm; NE: neuroendocrine; EBS: endoscopic biliary sphincterotomy; EPS: endoscopic pancreatic sphincterotomy; SEMS: self-expanding metal stent; FNA: fine needle aspiration.
Evaluating interventions at higher risk for AE (including needles knife sphincterortomy, manometry, ampullary biopsy, EPS, and minor duct papillotomy), we found no significant difference between inpatients and ASC subjects. There was also no significant difference in subjects who receive PD stents. All interventions are summarized in Table
AE occurred in 7.2% of the study population. The overall AE rate of the total inpatient population (11.2%) was not significantly higher compared to the ASC population (5.8%,
When we evaluated each individual’s procedure-related AE, no statistically significant differences in any groups or subpopulations were detected. Overall, 5.9% of subjects had PEP, among which there was no difference in the total inpatient versus ASC study population (8.2% versus 5.1%,
Outcomes and cost for inpatient versus ASC ERCP, EUS, and the total population.
ERCP | EUS | Total | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
IN | ASC | ALL | | IN | ASC | ALL | | IN | ASC | ALL | | |
| ||||||||||||
Postprocedural complications | 10 (13%) | 12 (8%) | 18 (8%) | 0.20 | 1 (5%) | 4 (3%) | 5 (4%) | 0.60 | 11 (11%) | 16 (6%) | 27 (7%) | 0.11 |
Pancreatitis | 7 (9%) | 11 (7%) | 18 (8%) | 0.60 | 1 (5%) | 3 (3%) | 4 (3%) | 0.20 | 8 (8%) | 14 (5%) | 22 (6%) | 0.43 |
Hemorrhage | 3 (4%) | 1 (1%) | 4 (2%) | 0.25 | 0 | 1 (1%) | 1 (1%) | 0.98 | 3 (3%) | 2 (0.7%) | 5 (1%) | 0.92 |
Perforation | 0 | 0 | 0 | 1.00 | 0 | 0 | 0 | 1.00 | 0 | 0 | 0 | 1.00 |
| ||||||||||||
| ||||||||||||
All-cause | 7 (9%) | 1 (1%) | 8 (3%) | 0.01 | 1 (5%) | 2 (2%) | 3 (2%) | 0.12 | 9 (9%) | 3 (1%) | 12 (3%) | 0.09 |
| ||||||||||||
| ||||||||||||
Fevers | 7 (9%) | 2 (1%) | 9 (4%) | 0.02 | 2 (9%) | 2 (2%) | 4 (3%) | 1.00 | 9 (9%) | 4 (1%) | 13 (4%) | 0.047 |
Nausea/vomiting | 8 (11%) | 17 (11%) | 25 (11%) | 0.87 | 0 | 7 (6%) | 7 (5%) | 0.98 | 8 (8%) | 24 (9%) | 32 (9%) | 0.79 |
Abdominal pain | 16 (21%) | 37 (23%) | 53 (23%) | 0.41 | 2 (9%) | 11 (9%) | 13 (9%) | 0.98 | 18 (18%) | 48 (17%) | 66 (18%) | 0.13 |
| ||||||||||||
| ||||||||||||
ED | 2 (3%) | 5 (3%) | 7 (3%) | 0.60 | 0 | 2 (2%) | 2 (%) | 0.94 | 2 (2%) | 7 (3%) | 9 (2%) | 0.70 |
Urgent care | 1 (1%) | 2 (1%) | 3 (1%) | 1.00 | 0 | 0 | 0 | 1.00 | 1 (1%) | 2 (1%) | 3 (1%) | 0.90 |
Hospitalization | 1 (1%) | 4 (3%) | 5 (2%) | 0.32 | 0 | 2 (2%) | 2 (1%) | 0.94 | 1 (1%) | 6 (2%) | 7 (2%) | 0.34 |
LOS | 9.3 | 0.6 | 3.6 | | 4.4 | 0.7 | 2.8 | 0.21 | 8.7 | 0.8 | 2.8 | |
Readmission | 8 (11%) | 10 (6%) | 18 (8%) | 0.04 | 1 (5%) | 10 (9%) | 11 (8%) | 0.80 | 9 (19%) | 20 (7%) | 29 (8%) | 0.17 |
| ||||||||||||
| ||||||||||||
Procedure | | | | 0.12 | | | | 0.35 | | | | |
Total | | | | | | | | 0.21 | | | | |
ERCP: endoscopic retrograde cholangiopancreatography; EUS: endoscopic ultrasound; IN: inpatients; ASC: ambulatory surgical center patients; ALL: inpatients + ASC patients; ARDS: acute respiratory distress syndrome; CI: confidence interval; SIRS: systemic inflammatory response syndrome; MOF: multiple organ failure; MI: myocardial infarction; ED: emergency department; LOS: length of stay.
When evaluating 30-day mortality (3.2% overall), there was no significant difference among the total populations (9% versus 1%), ERCP (9% versus 1%), and EUS (5% versus 2%) (Table
We found no significant difference in service calls for any reason (Table
Finally, mean procedural and total medical cost was evaluated. Mean procedural cost was significantly higher in the inpatient total population compared with the ASC population ($482.30 versus $423.20,
In this prospective, multicenter, observational study, we demonstrated no difference in overall or individual AE for subjects undergoing inpatient versus ASC advanced endoscopy. Our study population demonstrated a low AE rate, even with an increased incidence of high-risk procedural features and proportion with an ASA class ≥3.
At present, the American Society for Gastrointestinal Endoscopy (ASGE) has released two documents regarding quality indicators in therapeutic endoscopy [
Overall there is paucity of data regarding the safety of therapeutic endoscopy procedures in the ASC cancer population. Composite data from prior studies yielded low proportions of ampullary and pancreatic carcinomas when compared with our population [
Other than cancer subjects, another unique determination in our study is evaluation of AE in the ASC setting using this “higher risk” population. Freeman et al., among others, have evaluated various risk factors, which served to increase the risk of PEP, along with other AE after ERCP [
In addition to high-risk procedural factors, our study population did include a large proportion of subjects who had ASA classes greater than or equal to III (57.3% overall), determined to be high-risk from an anesthesia perspective. The ASA along with the ASGE has also expressed usage of ASA classes prior to endoscopic procedures [
At our institution, we utilize propofol-based anesthesia under the guidance of an anesthesiologist/Certified Registered Nurse Anesthetists (CRNA) for all endoscopic procedures. Using this care model, with no statistical difference in the mean ASA class in the inpatient population compared with the ASC population (2.8 inpatients versus 2.4 ASC subjects,
Potential weakness could have included our cost analysis for procedures that may have been different between inpatients and ASC subjects because of the instruments utilized between procedures. However, standardized tools were utilized for all cases. Another potential risk may have been the large number of variables examined, which led to our statistical cut-off being
In an age where healthcare costs continue to rise, the feasibility of performing both ERCP and EUS safely in the ASC setting has become of paramount importance. Also, with the publication of value-based metrics set forth by the ASGE, it has been integral for endoscopists to perform quality therapeutic procedures in a manner safe for subjects. In this prospective multicenter study, with 30-day follow-up, we determined that ERCP and EUS are safe and cost-effective procedures in the high-risk ASC population.
Endoscopic retrograde cholangiopancreatography
Endoscopic ultrasound
Endoscopic ultrasound with fine needle aspiration
Ambulatory surgical center
Sphincter of Oddi dysfunction
American Society for Anesthesiologists
New Jersey
Monitored anesthesia care
Postgraduate year
Boston Scientific Corporation, Incorporated
Angiotensin converting enzymes inhibitors
Angiotensin II receptor blocker
Intravenous fluids
Emergency department
Post-ERCP pancreatitis
Gastrointestinal bleeding
Acute coronary syndrome
Systemic inflammatory response syndrome
Multiple organ failure
End-stage renal disease
Length of stay
Analysis of variance
Statistical analysis system
Odds ratio
Endoscopic biliary sphincterotomy
Endoscopic pancreatic sphincterotomy
American Society for Gastrointestinal Endoscopy
Certified Registered Nurse Anesthetists.
Shaffer R. S. Mok, Henry C. Ho, and John P. Gaughan have no competing interests. Adam B. Elfant is a consultant for Boston Scientific Corporation.
The authors would like to thank Tara L. Lautenslager and Jeffrey M. Costanzo for their assistance in this project and care of the subjects. They would also like to thank Krystal Hunter for providing additional statistical support. Finally, they would like to thank Samuel N. Giordano for allowing them to involve his subjects in this study.