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

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ClinicalTrials.gov Identifier: NCT01047332
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
David L. Carr-Locke, MD, FRCP, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Inoperable Tumors of the Bile Duct
Interventions Device: Partially Covered Wallstent
Device: Uncovered Wallstent
Enrollment 129

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Uncovered Wallstent Partially Covered Wallstent
Hide Arm/Group Description Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Period Title: Overall Study
Started 61 68
Completed 4 [1] 4 [1]
Not Completed 57 64
Reason Not Completed
SEMS Obstruction             11             20
Died Unobstructed             38             41
Lost to Follow-up             8             3
[1]
Alive at final follow-up
Arm/Group Title Uncovered Wallstent Partially Covered Wallstent Total
Hide Arm/Group Description Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). Total of all reporting groups
Overall Number of Baseline Participants 61 68 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 68 participants 129 participants
65  (13) 66  (14) 66  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 68 participants 129 participants
Female
30
  49.2%
38
  55.9%
68
  52.7%
Male
31
  50.8%
30
  44.1%
61
  47.3%
1.Primary Outcome
Title Time to Recurrent Biliary Obstruction
Hide Description 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.
Time Frame Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Uncovered Wallstent Partially Covered Wallstent
Hide Arm/Group Description:
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Overall Number of Participants Analyzed 61 68
Median (Inter-Quartile Range)
Unit of Measure: days
711 [1] 
(283 to NA)
357
(264 to 1302)
[1]
Unable to calculate upper confidence interval because the largest value in the Kaplan-Meier analysis of time to recurrent biliary obstruction was censored.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Uncovered Wallstent, Partially Covered Wallstent
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.530
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Patient Survival
Hide Description 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.
Time Frame Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Uncovered Wallstent Partially Covered Wallstent
Hide Arm/Group Description:
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Overall Number of Participants Analyzed 61 68
Median (Inter-Quartile Range)
Unit of Measure: days
239
(84 to 401)
227
(99 to 365)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Uncovered Wallstent, Partially Covered Wallstent
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.997
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.
Time Frame From time of stent placement to participant death or lost to follow-up (up to 1302 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Uncovered Wallstent Partially Covered Wallstent
Hide Arm/Group Description:
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Overall Number of Participants Analyzed 61 68
Measure Type: Count of Participants
Unit of Measure: Participants
27
  44.3%
42
  61.8%
4.Secondary Outcome
Title Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism
Hide Description 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.
Time Frame Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Uncovered Wallstent Partially Covered Wallstent
Hide Arm/Group Description:
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Overall Number of Participants Analyzed 61 68
Measure Type: Number
Unit of Measure: participants
Tumor ingrowth 8 6
Tumor overgrowth 0 3
Stent migration 0 6
Sludge 1 4
Food debris in the stent 1 1
Stent failed to expand 0 1
Unknown 2 2
Time Frame From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Uncovered Wallstent Partially Covered Wallstent
Hide Arm/Group Description Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
All-Cause Mortality
Uncovered Wallstent Partially Covered Wallstent
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Uncovered Wallstent Partially Covered Wallstent
Affected / at Risk (%) Affected / at Risk (%)
Total   27/61 (44.26%)   42/68 (61.76%) 
Cardiac disorders     
Myocardial infarction  0/61 (0.00%)  1/68 (1.47%) 
Gastrointestinal disorders     
Pancreatitis  1/61 (1.64%)  0/68 (0.00%) 
Nausea  2/61 (3.28%)  2/68 (2.94%) 
Gastric outlet obstruction  5/61 (8.20%)  2/68 (2.94%) 
Radiation gastritis  1/61 (1.64%)  0/68 (0.00%) 
Gastrointestinal bleeding  5/61 (8.20%)  5/68 (7.35%) 
Vomiting  0/61 (0.00%)  1/68 (1.47%) 
Perforation  0/61 (0.00%)  2/68 (2.94%) 
Diarrhea  5/61 (8.20%)  1/68 (1.47%) 
Small bowel obstruction  2/61 (3.28%)  0/68 (0.00%) 
Hernia  0/61 (0.00%)  1/68 (1.47%) 
General disorders     
Stent migration  0/61 (0.00%)  8/68 (11.76%) 
Pain  6/61 (9.84%)  6/68 (8.82%) 
Hepatobiliary disorders     
Recurrent biliary obstruction  15/61 (24.59%)  34/68 (50.00%) 
Cholecystitis  3/61 (4.92%)  3/68 (4.41%) 
Liver abscess  2/61 (3.28%)  1/68 (1.47%) 
Cholangitis without biliary obstruction  1/61 (1.64%)  1/68 (1.47%) 
Infections and infestations     
Line infection  2/61 (3.28%)  2/68 (2.94%) 
Pneumonia  1/61 (1.64%)  7/68 (10.29%) 
Cellulitis  1/61 (1.64%)  0/68 (0.00%) 
Fever  1/61 (1.64%)  0/68 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1/61 (1.64%)  0/68 (0.00%) 
Nervous system disorders     
Stroke  0/61 (0.00%)  2/68 (2.94%) 
Seizure  0/61 (0.00%)  1/68 (1.47%) 
Change in mental status  1/61 (1.64%)  0/68 (0.00%) 
Renal and urinary disorders     
Urinary obstruction  0/61 (0.00%)  1/68 (1.47%) 
Kidney stone  1/61 (1.64%)  0/68 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema  0/61 (0.00%)  1/68 (1.47%) 
Shortness of breath  1/61 (1.64%)  0/68 (0.00%) 
Surgical and medical procedures     
Whipple resection  2/61 (3.28%)  1/68 (1.47%) 
Spinal surgery for cervical stenosis  0/61 (0.00%)  1/68 (1.47%) 
Vascular disorders     
Deep vein thrombosis  2/61 (3.28%)  2/68 (2.94%) 
Pulmonary embolus  1/61 (1.64%)  1/68 (1.47%) 
Epistaxis  0/61 (0.00%)  1/68 (1.47%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Uncovered Wallstent Partially Covered Wallstent
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/68 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David L. Carr-Locke, MD, FRCP
Organization: Brigham and Women’s Hospital
Responsible Party: David L. Carr-Locke, MD, FRCP, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01047332     History of Changes
Other Study ID Numbers: BS-816
First Submitted: January 8, 2010
First Posted: January 12, 2010
Results First Submitted: February 28, 2017
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017