P0837 - Comparison of Single Use Duodenoscopes and Reusable Duodenoscopes With a Single Cover for ERCP in a Tertiary Care Cancer Center

Sunday, October 22, 2023

3:30 PM – 7:00 PM PT

Location: Exhibit Hall

Has Audio

Presenting Author(s)

Antonio Pizuorno Machado, MD

University of Texas Health Science Center
Houston, TX

Antonio Pizuorno Machado, MD¹, Phillip Ge, MD², Brian R. Weston, MD², William A Ross, MD², Ahmad Al Nakshabandi, MD³, Daniel J. Low, MD², Jeffrey H. Lee, MD, MPH², Emmanuel Coronel, MD²
¹University of Texas Health Science Center, Houston, TX; ²University of Texas MD Anderson Cancer Center, Houston, TX; ³University of Texas MD Anderson Cancer Center, Houxton, TX

Introduction: The previous generation of duodenoscopes had a complex design that led to failure in proper decontamination and outbreaks of duodenoscope related infections. Recently, multiple endoscope manufacturers have addressed this issue and single use duodenoscopes (SD) and reusable duodenoscopes with a modified design (RD) are now available for clinical use. The aim of this study is to compare the performance of these devices in a complex patient population that require ERCP interventions.

Methods: This is a retrospective matched case-control study of adult patients who required ERCP procedures between 06/2020 and 12/2022. Cases were defined as all ERCPs performed with the SD (EXALT TM Model D, Boston Scientific, Marlborough, MA) and controls were defined as ERCPs performed with the RD with a single-use distal cover (TJF-Q190V, Olympus). Demographic and clinical characteristics, ERCP indications, maneuvers performed, and outcomes were collected. Adverse events were recorded. Controls were matched to cases according the ASGE complexity and maneuvers performed.

Results: A total of 156 patients were included. Most patients were male 93 (59.6%) and white 111 (71.1%). Mean age was 64 (IQR 54-72). Most patients had a previous diagnosis of pancreatic adenocarcinoma 61 (39.1%). There was no statistically significant difference between groups when adjusted by age, race, type of cancer and complexity. As for the device used for ERCP, in 52 (33.3%) patients the SD was used and in 104 (66.6%) the RD was used. Most ERCPs were ASGE Grade 3 in complexity 97 (62.1%). The median duration of ERCPs between groups did not reach significance ( p= 0.054). Most patients who had an ERCP with the SD had a prior ERCP (SD 63.4% versus RD 30.7%, p=0.0001). ERCP with SD failed in 7 patients (13.4%) for which usage of RD was needed and successful in 5 patients (9.6%). Most ERCP maneuvers that were attempted with the SD were successful, most cases performed with the SD had placement of biliary stents (p=0.04) while most cases performed with the RD had biliary dilation (p=0.003) and biliary sphincterotomy (p=0.001), mild complications appeared in 8 patients (5.1%), no severe adverse events were reported.

Discussion: This retrospective study shows that the use of the SD for complex ERCPs is technically feasible and safe. Approximately 10% of cases required crossover to a RD for ERCP completion, despite having a prior ERCP performed. Advances in technology and improvements in the design of SD may improve ERCP completion rates.

Table 1. ERCP - Characteristics	SD N=52	RD N= 104	P-value
Prior ERCP, n (%)	33 (63.4)	32 (30.7)	0.0001
Successful ERCP maneuvers
Esophageal Intubation, n (%)	51 (98)	104 (100)	NS
Passage to Stomach, n (%)	50 (96.1)	104 (100)	NS
Duodenal intubation, n (%)	49 (94.2)	104 (100)	NS
Biliary Cannulation, n (%)	45 (86.5)	104 (100)	NS
Biliary sphincterotomy, n (%)	2 (3.8)	36 (34.6)	< 0.001
Clearance of bile duct stones, n (%)	2 (3.8)	10 (9.6)	NS
Placement of biliary stents, n (%)	48 (92.3)	82 (78.8)	0.04
Placement of pancreatic stents, n (%)	1 (1.9)	6 (5.7)	NS
Balloon dilation of biliary stricture, n (%)	15 (28.8)	56 (53.8)	0.003
Mean duration of procedure (minutes) (SD)	43.4 (32.4)	55.2 (39.2)	NS
Failed ERCP, n (%)	7 (11.5)	0 (0)	-
Successful ERCP after switching to RD, n (%)	5 (9.6)	N/A	-
ERCP adverse events
Mild Pancreatitis, n (%)	1 (1.9)	3 (2.9)	-
Abdominal pain, n (%)	0 (0)	2 (1.9)	-
Post-sphincterotomy bleeding, n (%)	0 (0)	2 (1.9)	-
Total, n (%)	1 (1.9)	7 (6.1)	-
Abbreviations: RD = reusable duodenoscope, SD = single use duodenoscope, ERCP = endoscopic retrograde cholangiopancreatography, ASGE = American Society for Gastrointestinal Endoscopy, SD = standard deviation, NS= not significant

Table: Table 1. ERCP related characteristics and statistical analysis for both single use duodenoscopes and reusable duodenoscopes.

Disclosures:

Antonio Pizuorno Machado indicated no relevant financial relationships.

Phillip Ge: Alira Health – Consultant. Boston Scientific – Consultant. Neptune Medical – Consultant. Ovesco America – Consultant.

Brian Weston indicated no relevant financial relationships.

William A Ross indicated no relevant financial relationships.

Ahmad Al Nakshabandi indicated no relevant financial relationships.

Daniel Low indicated no relevant financial relationships.

Jeffrey Lee: Boston Scientific – Consultant. Pentax – Consultant.

Emmanuel Coronel indicated no relevant financial relationships.

Antonio Pizuorno Machado, MD¹, Phillip Ge, MD², Brian R. Weston, MD², William A Ross, MD², Ahmad Al Nakshabandi, MD³, Daniel J. Low, MD², Jeffrey H. Lee, MD, MPH², Emmanuel Coronel, MD². P0837 - Comparison of Single Use Duodenoscopes and Reusable Duodenoscopes With a Single Cover for ERCP in a Tertiary Care Cancer Center, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.