Biliary Endoscopic Drainage of Septic ICU Patients Deemed Emergent (BEDSIDE)

doi:10.21203/rs.3.rs-3867481/v1

Download PDF

Research Article

Biliary Endoscopic Drainage of Septic ICU Patients Deemed Emergent (BEDSIDE)

https://doi.org/10.21203/rs.3.rs-3867481/v1

This work is licensed under a CC BY 4.0 License

You are reading this latest preprint version

Background

Mortality for severe acute cholangitis is significantly reduced after endoscopic biliary drainage. Our institution has utilized ERCP without fluoroscopy in the intensive care unit (ICU), termed Biliary Endoscopic Drainage of Septic ICU patients Deemed Emergent (BEDSIDE) ERCP, in rare circumstances for critically ill patients with severe acute cholangitis where timely conventional ERCP was not available and delayed biliary drainage could adversely affect clinical outcomes. The objective of this study is to describe the BEDSIDE technique and its feasibility to provide expedited biliary drainage in critically ill patients in the ICU with severe acute cholangitis where timely conventional ERCP was not available.

Methods

We performed a retrospective cohort study from 2012–2022 at our tertiary care hospital system of patients who underwent BEDSIDE ERCP for acute cholangitis. Data collection included demographics, hospital course, and endoscopic findings.

Results

We identified 14 patients who underwent BEDSIDE ERCPs. Identified patients were critically ill with high incidences of vasopressor requirements (79%), mechanical ventilation (43%), and SIRS (100%). Median time from admission to ERCP was 13.6 hrs (range 9.3–18.5 hrs). BEDSIDE approach had successful biliary stent placement in 11 patients (79%), including all 5 patients with prior biliary sphincterotomies. 30-day cholangitis-related mortality was 14%.

Conclusion

BEDSIDE ERCP is proposed as a feasible approach to expedited biliary drainage for critically ill patients in the ICU with severe acute cholangitis in the rare circumstances that timely conventional ERCP with fluoroscopy is unavailable and further delayed biliary drainage could negatively affect clinical outcomes.

ERCP

endoscopy

cholangitis

sepsis

cholangiography

The Tokyo Guidelines for Acute Cholangitis (2018) helped to determine severity scoring for acute cholangitis with severe (grade III) defined as acute cholangitis that does not respond to initial conservative medical treatment and is associated with the onset of dysfunction in at least one organ system [1]. Prior to the advent of ERCP, mortality associated with severe acute cholangitis was greater than 50% [2]. The prognosis for acute cholangitis is predicated on timely administration of antibiotics, underlying patient comorbidities, and timing of biliary drainage with earlier biliary drainage associated with improved clinical outcomes [3], [4]. Guidelines on the management of cholangitis recommend endoscopic biliary drainage within 48 hours of admission to improve clinical outcomes, which is typically achieved with conventional ERCP aided by fluoroscopy [5]. After biliary drainage, the overall mortality of acute cholangitis decreases to less than 10% [6].

The urgency of infectious source control with endoscopic biliary drainage is magnified in septic patients with severe acute cholangitis who are admitted to the intensive care unit (ICU) for blood pressure support and management of end organ dysfunction. Although ERCP in these patients is deemed emergent, it can be delayed due to hemodynamic instability of the patient and limited availability of patient transportation, anesthesia personnel, fluoroscopy, and ERCP-capable procedure rooms [i.e. endoscopy suite or operating room (OR)]. Additional delays specific to our institution to pursuing timely conventional ERCP included competing for OR availability and personnel with a robust trauma surgery program, having a closed endoscopy unit outside of typical business hours, and being unable to utilize fluoroscopy in the ICU.

Our institution began performing ERCP without fluoroscopic guidance at bedside in the ICU in the early 2010’s in select patients with prior biliary sphincterotomies who presented with severe life-threatening acute cholangitis to expedite biliary decompression due to significant unforeseen delays to timely conventional ERCP. Initial success led to expansion of this approach to patients who had no prior biliary sphincterotomy. We have termed this procedure BEDSIDE – Biliary Endoscopic Drainage of Septic ICU patients Deemed Emergent. The purpose of this retrospective study is to describe the BEDSIDE technique and its feasibility to provide expedited biliary drainage in critically ill patients with severe acute cholangitis where timely conventional ERCP was not available.

We performed a retrospective cohort study of patients from 2012–2022 at our tertiary care hospital system who underwent BEDSIDE ERCP for management of acute cholangitis. Patients were identified initially by searching our endoscopy reporting database (ProVation MD, Minneapolis, MN, USA) for all ERCPs performed in our institution and subsequent manual review of inpatient electronic medical records to identify patients who underwent ERCP for acute cholangitis in the ICU. Acute cholangitis was defined as presence of Charcot’s triad, elevated white blood cell count and total bilirubin, and imaging demonstrating signs of biliary obstruction: common bile duct dilation, thickening of bile duct wall, and/or choledocholithiasis. Patients with prior acute cholangitis diagnoses or who had previously undergone ERCP, prior biliary sphincterotomy, and/or previous cholecystectomy were not excluded. Patients who were transported to the OR for initial ERCP with fluoroscopy for acute cholangitis were not included. Study protocol was approved by the Institutional Review Board of Human Investigation at University Hospitals of Cleveland Medical Center (STUDY 20220588).

General Technique For BEDSIDE

Sedation for this procedure is administered per ICU staff (no anesthesia personnel required), which includes either moderation sedation or propofol with many patients already intubated. Patient would be positioned in left lateral position for the procedure. After identification of the major papilla, a sphincterotome loaded with a guidewire is used to cannulate the biliary orifice by aiming at the 11 o'clock position. The sphincterotome is bowed towards the anticipated direction of the bile duct, and the guidewire is used to cannulate the duct with gradual probing of the duct to ensure that resistance is not felt upon insertion of at least 10 cm of wire, suggesting that selective deep biliary cannulation has been achieved. The length of inserted wire is monitored by measuring the wire at the accessory channel, taking care not to insert more than 20 cm of guidewire. Once the wire has achieved presumed deep biliary cannulation, the sphincterotome is advanced into the duct and a syringe is used to aspirate bile and/or pus, confirming successful biliary cannulation. If either bile or pus is not visualized upon aspiration, the catheter and guidewire are withdrawn, and cannulation is re-attempted. The markings on the sphincterotome are used to assess depth of insertion. The sphincterotome is withdrawn, and the guidewire is kept in place, while endoscopically observing the markings on the guidewire to ensure the wire stays in position. Next, a 10 Fr x 7 cm or 9 cm Cotton-Leung (Cook Medical, Bloomington, IN, USA) plastic biliary stent is inserted for biliary decompression using an OASIS One Action Stent Introduction System (Cook Medical, Bloomington, IN, USA). The stiffening introducer catheter is first inserted to the second mark, which corresponds to 13 cm; the pusher catheter is then disconnected from the introducer and used to push the stent into position. The entire procedure is performed under endoscopic guidance without fluoroscopy. A post-procedural abdominal radiography is then obtained to confirm positioning of the stent towards anatomic right, confirming biliary placement. Please refer to video demonstration for additional guidance on BEDSIDE ERCP supplies and technique. After successful biliary decompression, the patient is closely monitored for adverse events of ERCP (i.e. pancreatitis, abdominal pain, etc.) and continued supportive medical management for acute cholangitis. Patients are recommended to undergo repeat inpatient or outpatient ERCP with fluoroscopy to address primary pathology such as choledocholithiasis after the acute cholangitis has resolved. Refer to Video 1 that reviews the supplies and technique of BEDSIDE ERCP in a patient with severe acute cholangitis in the ICU.

Retrospective Data Extraction

Electronic medical records were reviewed. Data collection included patient demographics, clinical comorbidities, and if applicable, date of death. We additionally measured length of stay (LOS), vital signs, laboratory and imaging studies, medical interventions, and procedural adverse events. Patient’s pre-anesthesia medical co-morbidities were classified by ASA Physical Status Classification System [7]. Sepsis was defined as meeting at least two criteria of Systemic Inflammatory Response Syndrome (SIRS) classification [8]. Tokyo Guidelines for Acute Cholangitis (2018) were utilized for grading severity of acute cholangitis [1]. Lastly, we analyzed endoscopy reports for procedure timing plus endoscopic findings and interventions performed. We defined successful biliary duct decompression as placement of plastic biliary stent in biliary duct as confirmed by endoscopy and post-procedural imaging.

The primary outcome was feasibility of successful biliary drainage with biliary stent placement using the BEDSIDE ERCP technique for critically ill patients with severe acute cholangitis in the ICU. We performed simple analyses to describe and summarize the distributions of variables. All statistics were performed in R Studio.

Fourteen patients who underwent BEDSIDE ERCP were included in our study (Table 1). Five patients (36%) had prior biliary sphincterotomies. Refer to Table 2 for patient demographics and clinical characteristics. BEDSIDE patients were critically ill with high incidences of vasopressor requirements [11 patients (79%)], mechanical ventilation (MV) [6 patients (43%)], acute kidney injury (AKI) [12 patients (86%)], new hemodialysis requirements [2 patients (17%)], SIRS [14 patients (100%)], severe (grade III) acute cholangitis [13 patients (93%)], and ASA > 3 [10 patients (71%)]. Median time from admission to ERCP for patients was 13.6 hrs (range 9.3–18.5 hrs).

Table 1

Individual Patient Demographics and ERCP Findings
Case Number	Age (years)	Gender	Time to ERCP (hrs)¹	Prior Biliary Sphincterotomy	Successful Biliary Cannulation	Pus in Biliary Tract	Biliary Stent Placement	Reason for Unsuccessful Biliary Stent Placement	Repeat ERCP Inpatient	Death Within 30 Days of BEDSIDE ERCP
1	79	F	---	Yes	Yes	Yes	No	Unsuccessful removal of prior occluded biliary stent	Yes	Yes
2	85	F	7.3	Yes	Yes	No	Yes	---	Yes	No
3	74	M	9.6	Yes	Yes	Yes	Yes	---	No	No
4	57	F	---	No	Yes	No	Yes	---	No	Yes
5	70	M	20.5	Yes	Yes	Yes	Yes	---	No	No
6	72	F	11.2	No	Yes	Yes	Yes	---	Yes	No
7	83	F	3.1	No	Yes	Yes	Yes	---	Yes	No
8	81	F	13.7	No	Yes	No	No	Unable to confirm appropriate wire placement due to lack of bile aspiration	Yes	No
9	75	M	13.6	No	Yes	No	Yes	---	No	Yes²
10	85	F	17.2	No	Yes	Yes	Yes	---	No	No
11	89	F	18.1	No	Yes	Yes	Yes	---	No	Yes²
12	69	M	36.6	Yes	Yes	No	Yes	---	Yes	No
13	73	F	19.9	No	Yes	No	Yes	---	No	No
14	72	F	---	No	No	No	No	Inability to pass duodenoscope through a large paraesophageal hernia	No	No
¹time to ERCP not available for all patients due to ERCP prior to admission and/or lack of clinical suspicion for acute cholangitis upon initial presentation ²designating death attributed to acute cholangitis diagnosis

Table 2

Patient Demographics and Clinical Characteristics
	BEDSIDE ERCPs (n = 14)
Age, median (range), y	75 (57–89)
Female	10 (71%)
Male	4 (29%)
African American	3 (21%)
Caucasian	11 (79%)
Non-Hispanic or Latino	14 (100%)
BMI, median (range), kg/m²	32 (25–34)
Alcohol abuse	1 (7%)
Smoking	5 (36%)
COPD	2 (14%)
Heart failure	2 (14%)
Chronic kidney disease	2 (14%)
Cholecystectomy	6 (43%)
Prior biliary sphincterotomy	5 (36%)

For BEDSIDE patients, biliary cannulation was achieved in 12 patients (86%), including all 5 patients with prior biliary sphincterotomies. Pus was seen in the biliary tract for 7 patients (50%), and no patients underwent biliary balloon sweeps. One patient (7%) underwent a biliary sphincterotomy. Biliary stents were placed successfully in 11 patients (79%), which included all 5 patients with prior biliary sphincterotomies. Biliary stents were not placed in 3 patients (21%) due to unsuccessful removal of prior occluded biliary stent, unable to confirm appropriate wire placement due to lack of bile aspiration, and inability to pass duodenoscope through a large paraesophageal hernia. No intraprocedural bleeding or post-procedural adverse events were noted. Six patients (43%) underwent planned repeat conventional ERCP with fluoroscopy after BEDSIDE ERCPs during the same admission, of which only two patients had prior unsuccessful BEDSIDE ERCPs. No patients required rescue percutaneous or surgical biliary drainage despite overall illness severity. The patient with the large paraesophageal hernia did not undergo repeat ERCP due to subsequent clinical course decreasing the suspicion for severe acute cholangitis.

Median total bilirubin level (µmol/L) upon admission was 5.0 (range 2.0–8.7) and decreased to 2.0 (range 1.5–6.0) by post-procedure day 3. Median white blood cell count (cells x 10⁹/L) upon admission was 17.0 (range 7.0–22.0) and decreased to 10.0 (range 9.0–14.0) by post-procedure day 3. 7-day mortality and 30-day mortality were 21% (3 patients) and 29% (4 patients); however, 30-day mortality included only 2 patients (14%) with deaths attributed to acute cholangitis.

BEDSIDE ERCP was shown to be a feasible maneuver for expedited biliary drainage for severe acute cholangitis patients in the ICU in the situation of delayed timely conventional ERCP with fluoroscopy, especially if prior biliary sphincterotomy was present. We outline the procedural technique for BEDSIDE ERCP as adopted at our institution with experienced advanced endoscopists. No procedural adverse events were attributed to BEDSIDE ERCPs, and the 30-day cholangitis-associated mortality was comparable to previously published acute cholangitis mortality data [6].

BEDSIDE ERCP was successful in a majority (79%) of patients, providing expedited biliary drainage to critically ill patients where delayed intervention could have negatively affected clinical outcome. In patients with a prior biliary sphincterotomy, expedited biliary drainage with BEDSIDE ERCP was successful in all patients. Biliary stent placement was unsuccessful in three patients without prior biliary sphincterotomies. The additional support of fluoroscopy would not have been beneficial in two of these patients (large paraesophageal hernia and unsuccessful removal of prior occluded biliary stent); however, repeat ERCP with fluoroscopy was beneficial for one of these patients (inability to confirm appropriate wire placement due to lack of bile aspiration). Biliary cannulation rates with BEDSIDE ERCP for patients without prior biliary sphincterotomies were lower than conventional ERCP biliary cannulation rates; whereas, biliary cannulation rates are comparable to those of conventional ERCP for BEDSIDE ERCP in patients with prior biliary sphincterotomies [9]. Biliary sphincterotomy occurred in one patient with a native papilla with successful biliary duct stent placement and without an adverse event.

The BEDSIDE ERCP technique is proposed as an alternative biliary drainage maneuver to prevent delayed management rather than a replacement for conventional ERCP with fluoroscopy. We do not propose pursuing BEDSIDE ERCP when conventional ERCP is available in an expedited manner. Additionally, repeat conventional ERCP can be pursued (36%) after BEDSIDE ERCP during the same admission for choledocholithiasis management since biliary balloon sweeps are not attempted during BEDSIDE ERCP. BEDSIDE ERCP can be attempted in those with a native papilla, although the success rate will not be as high. If it fails, a conventional ERCP can be performed when the patient is hemodynamically stable for transport and a fluoroscopy-capable procedure room with appropriate personnel is available. All patients demonstrated improvement in clinical parameters after successful BEDSIDE ERCP as evidenced by decrease to near normal range in both median total bilirubin and white blood cell count from admission to post-procedure day 3.

Limitations of our study are namely its retrospective design and small cohort size. Overall mortality for acute cholangitis after biliary drainage is less than 10%; however, our study noted a 29% 30-day all-cause mortality rate [3]. The patients considered for BEDSIDE ERCP were inherently sicker, requiring ICU admission, vasopressor support, and having single or multi-organ failure, which all contribute to an increased mortality rate. Clinical history of a prior biliary sphincterotomy was considered but not required for BEDSIDE ERCP. BEDSIDE ERCP was pursued in ICU patients with severe cholangitis in the rare circumstances that emergent conventional ERCP with fluoroscopy was not available in a timely manner and there was clinical concern that delayed endoscopic biliary decompression could adversely affect clinical outcomes. The decision to pursue BEDSIDE ERCP for each patient included in our study could not be explicitly elucidated through retrospective chart review but likely contributing factors were repeat delays in OR availability due to staffing and room concerns in addition to worsening clinical status of the patients. Consideration to pursue BEDSIDE ERCP should be based on the advanced endoscopist’s evaluation of whether a delay in biliary drainage could significantly impact the patient’s clinical prognosis.

BEDSIDE ERCP is proposed as a feasible approach to expedited biliary drainage for critically ill patients with severe acute cholangitis in the rare circumstances that timely conventional ERCP with fluoroscopy is unavailable and further delayed biliary drainage could negatively affect clinical outcomes.

i. Ethics approval and consent to participate – “Study protocol was approved by the Institutional Review Board of Human Investigation at University Hospitals of Cleveland Medical Center (STUDY 20220588), and informed consent was waived.”

ii. Consent for publication – Not applicable.

iii. Availability of data and materials - The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.

iii. Competing interests – Authors Dr. Vibhu Chittajallu, Dr. Abbinaya Elangovan, Dr. Yazan Abu Omar, Dr. Sagarika Satyavada, Dr. Umar Hayat, Dr. Catherine Vozzo, Dr. Richard C. Wong, Dr. John A. Dumot, Dr. Brooke Glessing, Dr. Gerard A. Isenberg, Dr. Ashley L. Faulx, and Dr. Amitabh Chak have no conflicts of interest to disclose.

iv. Funding – No funding to disclose.

v. Authors' contributions - VC conception and design, analysis and interpretation of the data, drafting of article; AE conception and design and analysis and interpretation of the data; YAO analysis and interpretation of the data; SS critical revision of the article for important intellectual content; UH critical revision of the article for important intellectual content; CV critical revision of the article for important intellectual content; RCW critical revision of the article for important intellectual content; JAD critical revision of the article for important intellectual content; BG critical revision of the article for important intellectual content; GAI critical revision of the article for important intellectual content; ALF critical revision of the article for important intellectual content; AC critical revision of the article for important intellectual content and final approval of the article

Wada K, et al. Diagnostic criteria and severity assessment of acute cholangitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1). 10.1007/s00534-006-1156-7.
Andrew DJ, Johnson SE. Acute suppurative cholangitis, a medical and surgical emergency. A review of ten years experience emphasizing early recognition., Am J Gastroenterol, vol. 54, no. 2, pp. 141–54, Aug. 1970.
Ahmed M. Acute cholangitis - an update. World J Gastrointest Pathophysiol. Feb. 2018;9(1):1–7. 10.4291/wjgp.v9.i1.1.
Tan M, Schaffalitzky de OB, Muckadell, Laursen SB. Association between early ERCP and mortality in patients with acute cholangitis. Gastrointest Endosc. Jan. 2018;87(1):185–92. 10.1016/j.gie.2017.04.009.
Buxbaum JL, et al. ASGE guideline on the management of cholangitis. Gastrointest Endosc. 2021;94(2). 10.1016/j.gie.2020.12.032.
Zhang W-Z, Chen Y-S, Wang J-W, Chen X-R. Early diagnosis and treatment of severe acute cholangitis. World J Gastroenterol. Feb. 2002;8(1):150–2. 10.3748/wjg.v8.i1.150.
Saklad M. Grading of patients for surgical procedures. Anesthesiology. 1941;2:281–4.
Bone RC et al. Jun., Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine., Chest, vol. 101, no. 6, pp. 1644–55, 1992, 10.1378/chest.101.6.1644.
Saito H et al. Mar., Factors Predicting Difficult Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography for Common Bile Duct Stones., Clin Endosc, vol. 55, no. 2, pp. 263–269, 2022, 10.5946/ce.2021.153.

No competing interests reported.

Download PDF

Editorial decision: Revision requested
09 Aug, 2024
Reviews received at journal
04 Aug, 2024
Reviews received at journal
24 Jul, 2024
Reviewers agreed at journal
21 Jul, 2024
Reviewers agreed at journal
17 Jul, 2024
Reviewers agreed at journal
16 Jul, 2024
Reviewers invited by journal
16 Jul, 2024
Editor invited by journal
15 Jul, 2024
Editor assigned by journal
02 Feb, 2024
Submission checks completed at journal
02 Feb, 2024
First submitted to journal
15 Jan, 2024

You are reading this latest preprint version

Biliary Endoscopic Drainage of Septic ICU Patients Deemed Emergent (BEDSIDE)

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

INTRODUCTION

METHODS

General Technique For BEDSIDE

Retrospective Data Extraction

RESULTS

DISCUSSION

Declarations

References

Additional Declarations

Status:

Version 1