P1069 - Uncovered vs Fully Covered Self-Expandable Metal Stents for the Management of Distal Malignant Biliary Obstruction

Monday, October 25, 2021

10:30 AM – 4:15 PM PT

Location: Shoreline Exhibit Hall

Has Audio

Presenting Author(s)

Rabih Ghazi, MD

Mayo Clinic
Rochester, MN, United States

Rabih Ghazi, MD¹, Tala Mahmoud, MD¹, John A. Martin, MD¹, Ryan Law, DO¹, Michael J. Levy, MD¹, Barham K. Abu Dayyeh, MD, MPH¹, Andrew C. Storm, MD², Bret T. Petersen, MD¹, Vinay Chandrasekhara, MD¹
¹Mayo Clinic, Rochester, MN; ²Mayo Clinic College of Medicine, Rochester, MN

Introduction: Self-expandable metal stents (SEMS) are widely used for palliation of distal malignant biliary obstruction (dMBO). However, previous studies comparing the clinical outcomes between uncovered (UCSEMS) and covered (FCSEMS) report conflicting results. The primary aim of this study is to compare the clinical outcomes and adverse event (AE) rates between UCSEMS and FCSEMS.

Methods: This is a retrospective cohort study of patients with dMBO who underwent a SEMS placement between January 2018 and December 2020. Clinical success was defined as a reduction in serum bilirubin by either 33% within a week or 50% within 2 weeks of stent insertion, or as the resolution of symptoms attributed to biliary obstruction in patients with normal baseline bilirubin. The measured outcomes were compared between the two groups using Fisher’s exact test for categorical variables and Student’s t-test or Wilcoxon rank-sum test for continuous variables based on normal distribution.

Results: Our cohort included 234 patients (177 UCSEMS and 57 FCSEMS) (Table 1). Median duration of patient follow-up was 8.0 months and was similar between the two groups (p=0.289). UCSEMS and FCSEMS were associated with comparable rates of clinical success (87.6% vs 89.5%, p=0.817) and overall AEs (42.9% vs 40.4%, p=0.760). However, UCSEMS had a significantly higher rate of stent occlusion compared to FCSEMS (38.4% vs 15.8%, OR=3.3, p=0.002), a lower rate of post-ERCP pancreatitis (PEP) (4.0 vs 12.3%, OR=0.3, p=0.047), and lower rate of stent migration (1.7% vs 10.5%, OR=0.3, p=0.008). There was a higher rate of unplanned reinterventions with UCSEMS (37.9% vs 19.3%, OR=2.5, p=0.047). Both UCSEMS and FCSEMS had comparable median stent dwell time (8.0 vs 5.0 months, p=0.113), time to stent occlusion (4.0 vs 9.0 months, p=0.226) and time to unplanned reintervention (4.7 vs 4.0 months, p=0.826). The rates of other stent-related AEs were comparable between both groups.

Discussion: Overall, UCSEMS and FCSEMS were associated with similar rates of clinical success and AEs when used for palliation of dMBO. However, UCSEMS were associated with higher rates of stent occlusion and unplanned reintervention, but lower rates of PEP and stent migration. Endoscopists should consider these differences in AE profiles when considering SEMS for management of dMBO.

Table 1: Baseline characteristics and clinical outcomes of 234 patients who underwent metal biliary stent placement for the management of malignant distal biliary obstruction.
					UCSEMS			FCSEMS
		UCSEMS (n=177)	FCSEMS (n=57)	p-value	Flexxus (n=103)	Wallflex (n=74)	p-value	Wallflex (n=43)	Viabil (n=14)	p-value
Baseline Characteristics	Age	67.5 ±11.2	66.6 ±10.5	0.613	68.1 ±11.2	66.5 ±11.1	0.353	65.2 ±10.6	71.1 ±9.4	0.068
	Male	117 (66.1)	26 (45.6)	0.008	69 (70.0)	48 (64.9)	0.872	22 (51.2)	4 (28.6)	0.217
	BMI (kg/m²⁾	26.7 ±6.3	27.7 ±6.5	0.277	26.5 ±6.7	27.0 ±5.8	0.644	27.3 ±6.1	29.1 ±7.7	0.373
	Total Bilirubin (mg/dL)	5.3 (1.4-12.0)	3.4 (0.9-10.8)	0.363	6.3 (2.2-14.3)	3.3 (1.1-9.8)	0.028	3.6 (0.9-10.9)	3.2 (1.2-11.4)	0.934
	Duration of follow-up (months)	8.0 (3.0-14.5)	9.0 (4.0-19.5)	0.289	10.0 (3.0-16.0)	6.5 (2.0-11.3)	0.018	11.0 (5.0-25.0)	5.0 (0.8-11.3)	0.012
	Stent Diameter 8 mm 10 mm	10 (5.6) 167 (94.4)	5 (8.8) 52 (91.2)	0.370 -	7 (6.8) 96 (93.2)	3 (4.1) 71 (95.9)	0.524 -	0 (0.0) 43 (100.0)	5 (35.7) 9 (64.3)	< 0.001
Clinical Outcomes	Clinical Success	155 (87.6)	51 (89.5)	0.817	90 (87.4)	65 (87.8)	1.000	39 (90.7)	12 (85.7)	0.629
	Adverse Events	76 (42.9)	23 (40.4)	0.760	48 (46.6)	28 (37.8)	0.283	17 (39.5)	6 (42.9)	1.000
	Stent Occlusion	68 (38.4)	9 (15.8)	0.002	43 (41.7)	25 (33.8)	0.348	7 (16.3)	2 (14.3)	1.000
	Ingrowth Outgrowth Food and debris	53 (70.1) 1 (0.6) 14 (7.9)	2 (3.5) 0 (0.0) 7 (12.3)	< 0.001 1.000 0.300	36 (35.0) 0 (0.0) 7 (6.8)	17 (23.0) 1 (1.4) 7 (9.5)	0.098 0.418 0.579	1 (2.3) 0 (0.0) 6 (14.0)	1 (7.1) 0 (0.0) 1 (7.1)	0.434 - 0.669
	PEP	7 (4.0)	7 (12.3)	0.047	4 (3.8)	3 (4.1)	1.000	5 (11.6)	2 (14.3)	1.000
	Stent Migration	3 (1.7)	6 (10.5)	0.008	3 (2.9)	0 (0.0)	0.266	6 (14.0)	0 (0.0)	0.319
	In-migration	0 (0.0)	2 (3.5)	0.059	0 (0.0)	0 (0.0)	-	2 (4.7)	0 (0.0)	1.000
	Out-migration	3 (1.7)	4 (7.1)	0.062	3 (2.9)	0 (0.0)	0.266	4 (9.3)	0 (0.0)	0.563
	Other adverse events*	5 (2.8)	3 (5.3)	-	4 (3.9)	1 (1.4)	1 (2.3)	2 (14.2)	-	-
	Time to stent occlusion (months)	4.0 (3.0-7.0)	9.0 (1.5-15.5)	0.226	4.0 (3.0-6.0)	5.0 (3.0-8.0)	0.317	12.0 (6.0-18.0)	-	-
	Unplanned reintervention	67 (37.9)	11 (19.3)	0.001	42 (40.7)	25 (33.8)	0.432	8 (18.6)	3 (21.4)	1.000
	Time to unplanned reintervention (months)	4.7 (3.0-7.6)	4.0 (0.4-14.6)	0.826	4.6 (2.8-7.1)	5.5 (3.2-8.6)	0.294	12.3 (1.9-18.8)	0.4 (0.0-1.8)	-
	Stent dwell time (months)	8.0 (3.0-13.5)	5.0 (2.0-12.5)	0.113	10.0 (4.0-15.0)	6.0 (3.0-10.0)	0.009	8.0 (3.0-14.0)	2.0 (1-4.3)	0.001
UCSEMS uncovered self-expandable metal stent, FCSEMS fully covered self-expandable metal stent, PEP post-ERCP pancreatitis Values are presented as mean ±SD, median (IQR), or n (%) *Include stent maldeployment, cholecystitis, perforation, ulceration, and bleeding. No significant difference was found across the compared groups.

Table: Table 1: Baseline Characteristics and Clinical Outcomes of 234 Patients who Underwent Metal Biliary Stent Placement for the Management of Distal Malignant Biliary Obstruction.

Disclosures:

Rabih Ghazi indicated no relevant financial relationships.

Tala Mahmoud indicated no relevant financial relationships.

John Martin indicated no relevant financial relationships.

Ryan Law: Medtronic – Consultant. Olympus – Consultant. UpToDate – Other Financial or Material Support, Independent Contractor.

Michael Levy indicated no relevant financial relationships.

Barham Abu Dayyeh: Apollo Endosurgery – Grant/Research Support. BFKW – Consultant. Boston Scientific – Consultant. DyaMX – Consultant. Endogastric Solutions – Other Financial or Material Support, Speaking and Teaching. Hemostasis – Consultant. Johnson and Johnson – Consultant. Medtronic – Grant/Research Support. USGI – Grant/Research Support.

Andrew Storm: Boston Scientific – Grant/Research Support. ERBE – Consultant.

Bret Petersen: Abbvie – Stockholder/Ownership Interest (excluding diversified mutual funds). AMBU – Consultant. Boston Scientific – Grant/Research Support. Medtronic – Stockholder/Ownership Interest (excluding diversified mutual funds). Olympus America – Advisory Committee/Board Member. Pentax – Advisory Committee/Board Member. Pfizer – Stockholder/Ownership Interest (excluding diversified mutual funds).

Vinay Chandrasekhara: Covidien LLP – Consultant. Interpace Diagnostics – Advisory Committee/Board Member. Nevakar Corporation – Stockholder/Ownership Interest (excluding diversified mutual funds).

Rabih Ghazi, MD¹, Tala Mahmoud, MD¹, John A. Martin, MD¹, Ryan Law, DO¹, Michael J. Levy, MD¹, Barham K. Abu Dayyeh, MD, MPH¹, Andrew C. Storm, MD², Bret T. Petersen, MD¹, Vinay Chandrasekhara, MD¹. P1069 - Uncovered vs Fully Covered Self-Expandable Metal Stents for the Management of Distal Malignant Biliary Obstruction, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.