Trial Outcomes & Findings for Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction (NCT NCT01038713)

NCT ID: NCT01038713

Last Updated: 2016-06-23

Results Overview

Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: Time of stent occlusion, attempted surgical resection or patient death to 300 days
• Results posted on: 2016-06-23

Participant Flow

The protocol initially was designed to measure five groups - we elected not to study patients with unresectable disease and thus only patients with presumed resectable disease are included

94 patients recruited for the study. 63 were randomized into three arms

Participant milestones

Measure	Resectable; Plastic Stent Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Overall Study STARTED	26	20	17
Overall Study COMPLETED	21	17	16
Overall Study NOT COMPLETED	5	3	1

Reasons for withdrawal

Measure	Resectable; Plastic Stent Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Overall Study Patient to hospice	1	1	1
Overall Study Lost to Follow-up	3	0	0
Overall Study Neuroendocrine Tumor	0	1	0
Overall Study died from PEP	0	1	0
Overall Study Autoimmune Pancreatitis	1	0	0

Baseline Characteristics

Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Baseline characteristics by cohort

Measure	Resectable; Plastic Stent n=21 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent n=17 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent n=16 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Total n=54 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 9.67 • n=5 Participants	64.8 years STANDARD_DEVIATION 8.47 • n=7 Participants	67.2 years STANDARD_DEVIATION 11.4 • n=5 Participants	65.9 years STANDARD_DEVIATION 9.74 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment United States	21 participants n=5 Participants	17 participants n=7 Participants	16 participants n=5 Participants	54 participants n=4 Participants

PRIMARY outcome

Timeframe: Time of stent occlusion, attempted surgical resection or patient death to 300 days

Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement

Outcome measures

Measure	Resectable; Plastic Stent n=21 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent n=17 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent n=16 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. Attempted Surgical Resection	4 participants	6 participants	8 participants
Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. Death	6 participants	5 participants	4 participants
Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction. Stent Occlusion	11 participants	6 participants	4 participants

SECONDARY outcome

Timeframe: Costs measured up to 500 days

Outcome measures

Measure	Resectable; Plastic Stent n=21 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent n=17 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent n=16 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.	39,955 United States Dollars	41,476 United States Dollars	41,112 United States Dollars

SECONDARY outcome

Timeframe: From stent placement up to 500 days post stent

Number of total days of hospitalization for all patients in each group

Outcome measures

Measure	Resectable; Plastic Stent n=21 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent n=17 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent n=16 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Determine the Days of Hospitalization Following Stent Placement	0 Days	14 Days	15 Days

SECONDARY outcome

Timeframe: Time from stent placement to 500 days

Total number of days in which neoadjuvant therapy was delayed due to stent related issues

Outcome measures

Measure	Resectable; Plastic Stent n=21 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent n=17 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent n=16 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents	73 Days	50 Days	3 Days

SECONDARY outcome

Timeframe: time from stent placement to 500 days

Outcome measures

Measure	Resectable; Plastic Stent n=21 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent n=17 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent n=16 Participants Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Assess Rate of Acute Cholecystitis Associated With Each Type of Stent	0 Participants	0 Participants	0 Participants

Adverse Events

Resectable; Plastic Stent

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Resectable; Uncovered Metal Stent

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Resectable; Fully Covered Metal Stent

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Resectable; Plastic Stent n=21 participants at risk Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Uncovered Metal Stent n=17 participants at risk Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.	Resectable; Fully Covered Metal Stent n=16 participants at risk Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction. Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP.
Gastrointestinal disorders Post-ERCP Pancreatitis	0.00% 0/21 • Time from stent placement to 500 days	17.6% 3/17 • Time from stent placement to 500 days	18.8% 3/16 • Time from stent placement to 500 days

Additional Information

Timothy Gardner

Dartmouth-Hitchcock Medical Center

Phone: 603-650-6472

Email: timothy.b.gardner@hitchcock.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place