Outpatient therapeutic ERCP: a series of 262 consecutive cases

doi:10.1016/S0016-5107(96)70097-4

Gastrointestinal Endoscopy

Volume 44, Issue 4, October 1996, Pages 443-449

https://doi.org/10.1016/S0016-5107(96)70097-4 Get rights and content

Abstract

Background: Because of possible complications, it has been common practice to admit most if not all patients undergoing therapeutic ERCP. Therefore, little descriptive data exist on the safety of outpatient therapeutic ERCP.

Methods: We assessed 262 consecutive ERCPs in 209 patients undergoing outpatient therapeutic ERCP over a 5-year period, with particular attention to the development of complications. All outpatient endoscopic sphincterotomies and stent placements performed over a 5-year period were prospectively entered into an ongoing data base that was used for the analysis. In addition, hospital and office records for all patients were retrospectively reviewed, including a 30 to 45 day follow-up in a private office setting.

Results: Suspected or documented choledocholithiasis was the most common indication for ERCP and was present in 132 (50%), followed by malignant obstruction in 77 (29%), type I sphincter of Oddi dysfunction (on the basis of symptoms, liver test abnormalities, and bile duct dilatation) in 36 (14%), chronic pancreatitis in 10 (3.8%), HIV cholangiopathy in 4 (1.5%), and other conditions in 3 (1.1%). Overall, 181 patients (69%) underwent a sphincterotomy. The 30-day post-ERCP complication rate was 5.7% (95% CI: 3.2% to 9.3%), occurring in 15 of 262 cases. Complications necessitating hospitalization developed in 9 of the 262 ERCPs for a rate of 3.4% (95% CI: 1.6% to 6.4%). The mean duration of hospital stay among patients admitted for a complication was 2.7 ± 1.8 days (range, 1 to 7 days). All patients were discharged without permanent sequelae. No 30-day procedure-related fatalities were reported.

Conclusion: In this selected series of 262 consecutive cases, endoscopic sphincterotomy and stent placement were safely performed in an ambulatory setting. Prior to recommending a generalized change in existing practice, however, this finding requires validation with larger series of cases, including the performance of other outpatient therapeutic ERCP techniques. (Gastrointest Endosc 1996;44:443-9.)

Section snippets

Patient selection

Over a 5-year period, 1291 ERCPs were completed by a single endoscopist at the Montreal General Hospital. Of these, 590 (46%) were performed on an outpatient basis. Patients who had ERCP performed on an outpatient basis were those who fulfilled the following criteria: any nonadmitted patient exhibiting an American Society of Anaesthesiologists (ASA) score less than or equal to 3,²¹ without coagulopathy or active cholangitis, and who lived within 30 minutes of the Montreal General Hospital or

Study population

Overall, 262 consecutive outpatient ERCPs were performed in 209 patients. The study population (Table 1) included 77 (37%) men and 132 (63%) women. The mean age was 51.9 ± 31.3 years (range, 16 to 98). Sixty-five (31%) patients resided within the immediate city limits, 85 (41%) lived within 30 minutes of the Montreal General Hospital, with the remaining 59 (28%) residing at further distances from the Montreal General Hospital. At the time of ERCP, 72 (34%) patients were receiving no

DISCUSSION

Therapeutic ERCP procedures are among the most effective of currently available techniques for the management of pancreaticobiliary disorders. They are also among the most complex and hazardous that endoscopists perform today, yet are quite safe when carried out by an experienced endoscopist.²⁵ Nonetheless, significant complications do occasionally develop, even in experienced hands. Large prospective and retrospective series have defined the incidence of complications arising from ERCP. These

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Cited by (40)

Development and Validation of a Prediction Model for Admission After Endoscopic Retrograde Cholangiopancreatography
2015, Clinical Gastroenterology and Hepatology
Citation Excerpt :
The majority of post-ERCP complications (>70%) can be identified within the first 6 hours after procedure.9 As reflected in these data, our practice has been to observe almost all of our patients for several hours after their procedure, with selective testing of serum amylase/lipase in the PACU for those at risk for PEP.5–7,10,18,19 However, these data were generated in an era of moderate sedation, where patients would receive high doses of opiates for sedation that could have masked the symptoms of post-ERCP complication.
In outpatients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with anesthesia, rates of and risk factors for admission are unclear. We aimed to develop a model that would allow physicians to predict hospitalization of patients during postanesthesia recovery.
We conducted a retrospective study of data from ERCPs performed on outpatients from May 2012 through October 2013 at the Indiana University School of Medicine. Medical records were abstracted for preanesthesia, intra-anesthesia, and early (within the first hour) postanesthesia characteristics potentially associated with admission. Significant factors associated with admission were incorporated into a logistic regression model to identify subgroups with low, moderate, or high probabilities for admission. The population was divided into training (first 12 months) and validation (last 6 months) sets to develop and test the model.
We identified 3424 ERCPs during the study period; 10.7% of patients were admitted to the hospital, and 3.7% developed post-ERCP pancreatitis. Postanesthesia recovery times were significantly longer for patients requiring admission (362.6 ± 213.0 minutes vs 218.4 ± 71.8 minutes for patients not admitted; P < .0001). A higher proportion of admitted patients had high-risk indications. Admitted patients also had more severe comorbidities, higher baseline levels of pain, longer procedure times, performance of sphincter of Oddi manometry, higher pain during the first hour after anesthesia, and greater use of opiates or anxiolytics. A multivariate regression model identified patients who were admitted with a high level of accuracy in the training set (area under the curve, 0.83) and fair accuracy in the validation set (area under the curve, 0.78). On the basis of this model, nearly 50% of patients could be classified as low risk for admission.
By using factors that can be assessed through the first hour after ERCP, we developed a model that accurately predicts which patients are likely to be admitted to the hospital. Rates of admission after outpatient ERCP are low, so a policy of prolonged observation might be unnecessary.
Outpatient ERCP-everybody is doing it: does this make it right?
2008, Gastrointestinal Endoscopy
ERCP as an outpatient treatment: a review
2008, Gastrointestinal Endoscopy
Citation Excerpt :
For example, there may be a difference in the risk for post-ERCP complications between pancreatic-stent placement and biliary-stent placement or between a pancreatic and a biliary sphincterotomy. Unfortunately, most reviewed studies did not distinguish between these treatments.5,10-12,15 In addition, patients who were undergoing a high-risk ERCP procedure (ie, pancreatic therapy), associated with SOD or with concurrent comorbidity were already scheduled for 24-hour postprocedural observation in some studies.5,11-13,15
ERCP on an outpatient basis could be as safe as on an inpatient basis and may also reduce medical costs.
To review the available literature to determine the safety of an ERCP performed on an outpatient basis.
A review of the published literature was performed by searching PubMed, the Cochrane Library, EMBASE, and the Web of Science.
Patients who were undergoing an ERCP.
An ERCP on an inpatient or outpatient basis.
Patient and treatment characteristics, complications, and prolonged hospital admissions and readmissions.
Eleven studies were included in this review, of which 5 were comparative studies, 5 were prospective studies, and 1 was a retrospective study. In these series, a total of 2483 patients underwent an ERCP on an outpatient basis and 2320 patients were admitted overnight after an ERCP. Complications were seen in 184 of 2483 outpatients (7%), of which 72% of complications (107/149) presented within 2 to 6 hours, 10% (15/149) within 6 to 24 hours, and 18% (27/149) more than 24 hours after the ERCP. Three percent of the inpatients (82/2320) developed a complication, of which 95% of complications (78/82) presented within 24 hours and 5% (4/82) presented more than 24 hours after the ERCP. A prolonged hospital stay after an ERCP was indicated in 6% of the designated outpatients (148/2483), whereas 3% of outpatients (74/2149) and <1% of inpatients (4/2320) were readmitted after discharge.
Limited data available.
This review shows that, with a selective policy, an ERCP on an outpatient basis seems as safe as when performed on an inpatient basis.
Complications after ERCP in patients with primary sclerosing cholangitis
2008, Gastrointestinal Endoscopy
Citation Excerpt :
The study protocol was reviewed and approved by the University of Washington Institutional Review Board. Sample size was calculated by estimating a complication rate of 18% and 6% for PSC and non-PSC indications, respectively, on the basis of available literature.3,4,16,19-26 Assuming an α error of 5%, a sample size of 68 in each group was estimated to result in a 70% power to detect differences.
There are conflicting data regarding the role of ERCP in patients with primary sclerosing cholangitis (PSC) and the risk of procedure-related complications.
We compared the complication rate after ERCP in a consecutive series of patients with PSC compared with control patients with biliary strictures who did not have PSC.
Retrospective cross-sectional study.
A tertiary referral academic hospital.
Incidence of complications after ERCP.
A total of 85 ERCPs among 30 patients with PSC and 70 ERCPs among 45 control patients were reviewed. There was no significant difference in the overall complication rates between patients with and without PSC (11/85 [12.9%] vs 6/70 [8.6%], P = .45). Complications in PSC were more likely to occur after ERCP done to evaluate an acute sign or symptom than in elective cases (7/24 [29.2%] vs 4/61 [6.6%], P = .01). Patients with PSC who had complications had more total and acute ERCPs than did those without complications. There was no significant difference in the rate of complications in diagnostic versus therapeutic ERCPs nor between stent placement and dilation-only therapeutic ERCPs in the PSC population.
Retrospective study design and limited power related to the small sample sizes.
Elective ERCP is safe and carries a modest risk in patients with PSC; however, ERCP for acute indications greatly increases the probability of postprocedure complications. The overall complication rate after therapeutic ERCP in patients with PSC is similar to that in patients without PSC.
A Prospective Study of Complications of Endoscopic Retrograde Cholangiopancreatography and Endoscopic Ultrasound in an Ambulatory Endoscopy Center
2006, Clinical Gastroenterology and Hepatology
Background & Aims: Our aim was to assess the safety of endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound (EUS) in an ambulatory endoscopy center (AEC). Methods: Complications occurring in consecutive patients undergoing ERCP or EUS from March 2003 to February 2004 at our AEC were recorded prospectively. Comprehensive complications were defined as consensus criteria plus other adverse events: use of reversal agents, unplanned hospital admission, hospitalization beyond planned 23-hour observation, unplanned emergency department or primary care provider visit, and 30-day mortality. Results: A total of 497 patients (median age, 57 y; 82% American Society of Anesthesiologists class II or III) underwent 685 procedures. Monitored or general anesthesia was used in 25% of EUS and 50% of ERCP procedures. ERCP interventions were as follows: biliary or pancreatic stenting (N = 168), stone extraction (N = 70), sphincterotomy (N = 62), sphincter of Oddi manometry (N = 53), other (N = 66). EUS indications were as follows: known or suspected pancreatic mass (N = 103), upper-gastrointestinal mass/submucosal lesion (N = 71), luminal malignancy staging (N = 40), other (N = 96); 52% had EUS fine-needle aspiration. There was follow-up evaluation in 94% of the patients. There were 43 comprehensive ERCP complications (12.9%), 18 (5.4%) of these fit consensus criteria: pancreatitis (N = 14), cholangitis (N = 2), and perforation (N = 2). There were 9 comprehensive EUS complications (2.9%), 2 (.7%) of these fit consensus criteria: pancreatitis (N = 1) and bleeding (N = 1). Other adverse events for ERCP and EUS were as follows: prolongation of 23-hour observation (N = 14), emergency room visits (N = 3), primary care physician visits (N = 6), use of reversal agents (N = 3), unplanned admissions (N = 2), infection (N = 3), and death (N = 1). Conclusions: ERCP and EUS can be performed in an AEC, provided mechanisms for admission and anesthesia support are in place. The assessment of comprehensive complications is more reflective of adverse events related to ERCP and EUS than consensus criteria alone.
A randomized trial of endoscopic biliary sphincterotomy using pure-cut versus combined cut and coagulation waveforms
2005, Clinical Gastroenterology and Hepatology
Background & Aims: Endoscopic biliary sphincterotomy has complication rates of 5%–12%. The output from the electrosurgical generator may influence the degree of coagulation and the rapidity of the incision, and thus rates of pancreatitis, hemorrhage, and perforation. Some modern generators incorporate feedback control to standardize output and automate the alternating cut and coagulation modes. Our aim was to compare 2 feedback-controlled generators, one with constant pure cutting–type output and the other with an alternating cut and coagulation mode. Methods: In this multicenter randomized study, 133 patients were assigned to the alternating cut/coag output and 134 patients were assigned to constant pure-cut output. Patients were stratified by their risk for pancreatitis. Results: The overall pancreatitis rate was 1.5%, including 3 patients in the cut/coag group and 1 patient in the pure-cut group (P > .05). There were 11 poorly controlled (zipper) incisions in the pure-cut group and none in the cut/coag group (P = .02). The incision was completed in all patients without stalling. Immediate hemorrhage occurred in 35 pure-cut patients and 8 cut/coag patients output (P = .002). There were no episodes of clinically significant bleeding, delayed bleeding, or perforation. Conclusions: Biliary sphincterotomy using feedback-controlled generators results in dependable progression of incision with a low pancreatitis rate. Control of the incision is improved subjectively with the cut/coagulation output, but this did not translate into a difference in clinically significant complications.

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^☆: From the Montreal General Hospital, Montreal, Quebec, Canada.

^☆☆: Reprint requests: Alan N. Barkun, MD, Gastroenterology, Room D7.148, The Montreal General Hospital, 1650 Cedar Ave., Montreal, Quebec, CANADA, H3G 1A4.

^★: 37/1/72877

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Outpatient therapeutic ERCP: a series of 262 consecutive cases☆,☆☆,★

Abstract

Section snippets

Patient selection

Study population

DISCUSSION

Lancet

Gastroenterology

Surg Clin North Am

Gastrointest Endosc

Gastrointest Endosc

Gastrointest Endosc

Gastroenterology

Gastrointest Endosc

Clin Radiol

Clin Gastroenterol

Gastrointest Endosc

Complications of therapeutic gastrointestinal endoscopy

Endoscopy

Complications of endoscopic sphincterotomy and their treatment

Endoscopy

Computer analysis of a decade of ERCP

Gut

Early and late complications after endoscopic sphincterotomy for biliary lithiasis with and without the gallbladder in situ

Gut

Endoscopic sphincterotomy of the papilla of Vater: an analysis of 300 cases

Aust NZ J Med

Hemmorhage from endoscopic sphincterotomy (ES): a prospective, multicenter, 30-day study

Gastrointest Endosc

Pancreatitis from endoscopic sphincterotomy (ES): a prospective, multicenter, 30-day study

Gastrointest Endosc

Major complications from diagnostic and therapeutic ERCP: a prospective multicenter study

Gastroenterology

The experience of use of endoscopic papillotomy

Klin Med (Mosk)

Endoscopic papillotomy for common bile duct stones: factors influencing the complication rate

Endoscopy

Endoscopic sphincterotomy. Its complications and their follow-up

Acta Gastroenterol Latinoam

Successes, failures, early complications and their management following endoscopic sphincterotomy: results in 394 consecutive patients from a single centre

Br J Surg

Endoscopic sphincterotomy in 1000 consecutive patients

Lancet

Endoscopic retrograde cholangiopancreatography. A diagnostic outpatient procedure

AORN J

Endoscopic papillotomy in the treatment of biliary tract disease—258 procedures and results

Dig Dis Sci

Endoscopic papillotomy

Surgery

ASA physical status classification: a study of consistency of ratings

Anesthesiology