Trial Outcomes & Findings for A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures (NCT NCT01047332)

Last Updated: 2017-04-11

Results Overview

Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.

Recruitment status

COMPLETED

Study phase

Target enrollment

129 participants

Primary outcome timeframe

Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

Results posted on

2017-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Uncovered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Overall Study STARTED	61	68
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	57	64

Reasons for withdrawal

Reasons for withdrawal
Measure	Uncovered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Overall Study SEMS Obstruction	11	20
Overall Study Died Unobstructed	38	41
Overall Study Lost to Follow-up	8	3

Baseline Characteristics

A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Uncovered Wallstent n=61 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent n=68 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).	Total n=129 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 13 • n=5 Participants	66 years STANDARD_DEVIATION 14 • n=7 Participants	66 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	38 Participants n=7 Participants	68 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	30 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

Population: All randomized participants.

Outcome measures

Outcome measures
Measure	Uncovered Wallstent n=61 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent n=68 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Time to Recurrent Biliary Obstruction	711 days Interval 283.0 to Unable to calculate upper confidence interval because the largest value in the Kaplan-Meier analysis of time to recurrent biliary obstruction was censored.	357 days Interval 264.0 to 1302.0

SECONDARY outcome

Timeframe: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

Population: All randomized participants.

Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.

Outcome measures

Outcome measures
Measure	Uncovered Wallstent n=61 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent n=68 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Patient Survival	239 days Interval 84.0 to 401.0	227 days Interval 99.0 to 365.0

SECONDARY outcome

Timeframe: From time of stent placement to participant death or lost to follow-up (up to 1302 days)

Population: All randomized participants.

Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.

Outcome measures

Outcome measures
Measure	Uncovered Wallstent n=61 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent n=68 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Number of Participants With Serious Adverse Events (SAEs)	27 Participants	42 Participants

SECONDARY outcome

Timeframe: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm

Population: All randomized participants.

Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.

Outcome measures

Outcome measures
Measure	Uncovered Wallstent n=61 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent n=68 Participants Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism Food debris in the stent	1 participants	1 participants
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism Tumor ingrowth	8 participants	6 participants
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism Tumor overgrowth	0 participants	3 participants
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism Stent migration	0 participants	6 participants
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism Sludge	1 participants	4 participants
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism Stent failed to expand	0 participants	1 participants
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism Unknown	2 participants	2 participants

Adverse Events

Uncovered Wallstent

Serious events: 27 serious events

Other events: 0 other events

Deaths: 0 deaths

Partially Covered Wallstent

Serious events: 42 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Dr. David L. Carr-Locke, MD, FRCP

Brigham and Women's Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Uncovered Wallstent n=61 participants at risk Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).	Partially Covered Wallstent n=68 participants at risk Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Hepatobiliary disorders Recurrent biliary obstruction	24.6% 15/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	50.0% 34/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
General disorders Stent migration	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	11.8% 8/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Pancreatitis	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Hepatobiliary disorders Cholecystitis	4.9% 3/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	4.4% 3/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
General disorders Pain	9.8% 6/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	8.8% 6/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Infections and infestations Line infection	3.3% 2/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	2.9% 2/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Nausea	3.3% 2/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	2.9% 2/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Metabolism and nutrition disorders Dehydration	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Vascular disorders Deep vein thrombosis	3.3% 2/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	2.9% 2/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Gastric outlet obstruction	8.2% 5/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	2.9% 2/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Radiation gastritis	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Infections and infestations Pneumonia	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	10.3% 7/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Nervous system disorders Stroke	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	2.9% 2/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Surgical and medical procedures Whipple resection	3.3% 2/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Gastrointestinal bleeding	8.2% 5/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	7.4% 5/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Vomiting	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Perforation	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	2.9% 2/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Diarrhea	8.2% 5/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Small bowel obstruction	3.3% 2/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Gastrointestinal disorders Hernia	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Hepatobiliary disorders Liver abscess	3.3% 2/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Hepatobiliary disorders Cholangitis without biliary obstruction	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Infections and infestations Cellulitis	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Infections and infestations Fever	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Nervous system disorders Seizure	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Nervous system disorders Change in mental status	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Surgical and medical procedures Spinal surgery for cervical stenosis	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Vascular disorders Pulmonary embolus	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Cardiac disorders Myocardial infarction	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Respiratory, thoracic and mediastinal disorders Shortness of breath	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Renal and urinary disorders Urinary obstruction	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Renal and urinary disorders Kidney stone	1.6% 1/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	0.00% 0/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Vascular disorders Epistaxis	0.00% 0/61 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).	1.5% 1/68 • From time of stent placement to participant death or lost to follow-up (up to 1302 days).