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

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ClinicalTrials.gov Identifier: NCT01038713
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : June 22, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Intervention Device: Biliary stent placement
Enrollment 94
Recruitment Details 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
Pre-assignment Details 94 patients recruited for the study. 63 were randomized into three arms
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 26 20 17
Completed 21 17 16
Not Completed 5 3 1
Reason Not Completed
Patient to hospice             1             1             1
Lost to Follow-up             3             0             0
Neuroendocrine Tumor             0             1             0
died from PEP             0             1             0
Autoimmune Pancreatitis             1             0             0
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 21 17 16 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 17 participants 16 participants 54 participants
65.9  (9.67) 64.8  (8.47) 67.2  (11.4) 65.9  (9.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 17 participants 16 participants 54 participants
Female
10
  47.6%
6
  35.3%
7
  43.8%
23
  42.6%
Male
11
  52.4%
11
  64.7%
9
  56.3%
31
  57.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 17 participants 16 participants 54 participants
21 17 16 54
1.Primary Outcome
Title Assess the Occlusion Rates, Attempted Surgical Resection or Death of Plastic, Covered, and Uncovered Biliary Stents in Patients Presenting With Malignant Biliary Obstruction.
Hide Description Number of participants who developed stent occlusion, attempted surgical resection or death following stent placement
Time Frame Time of stent occlusion, attempted surgical resection or patient death to 300 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 17 16
Measure Type: Number
Unit of Measure: participants
Stent Occlusion 11 6 4
Attempted Surgical Resection 4 6 8
Death 6 5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Resectable; Plastic Stent, Resectable; Uncovered Metal Stent, Resectable; Fully Covered Metal Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments Analysis comparing the number of patients who had stent occlusion
Method Chi-squared
Comments 3 x 2 contingency table comparing all three groups
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Resectable; Plastic Stent, Resectable; Uncovered Metal Stent, Resectable; Fully Covered Metal Stent
Comments Analysis comparing the rate of attempted surgical resection
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Chi-squared
Comments 3 x 2 contingency table comparing all three groups
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Resectable; Plastic Stent, Resectable; Uncovered Metal Stent, Resectable; Fully Covered Metal Stent
Comments Analysis comparing the rate of death between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Chi-squared
Comments 3 x 2 contingency table comparing all three groups
2.Secondary Outcome
Title Total Cost Associated With the Placement of Biliary Stents Including the Cost of the Device as Well as the Secondary Costs of Device Placement.
Hide Description [Not Specified]
Time Frame Costs measured up to 500 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 17 16
Measure Type: Number
Unit of Measure: United States Dollars
39,955 41,476 41,112
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Resectable; Plastic Stent, Resectable; Uncovered Metal Stent, Resectable; Fully Covered Metal Stent
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Determine the Days of Hospitalization Following Stent Placement
Hide Description Number of total days of hospitalization for all patients in each group
Time Frame From stent placement up to 500 days post stent
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 17 16
Measure Type: Number
Unit of Measure: Days
0 14 15
4.Secondary Outcome
Title Assess Days Neoadjuvant Therapy Was Delayed Due to Complications Associated With the Stents
Hide Description Total number of days in which neoadjuvant therapy was delayed due to stent related issues
Time Frame Time from stent placement to 500 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 17 16
Measure Type: Number
Unit of Measure: Days
73 50 3
5.Secondary Outcome
Title Assess Rate of Acute Cholecystitis Associated With Each Type of Stent
Hide Description [Not Specified]
Time Frame time from stent placement to 500 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 17 16
Measure Type: Number
Unit of Measure: Participants
0 0 0
Time Frame Time from stent placement to 500 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/17 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Resectable; Plastic Stent Resectable; Uncovered Metal Stent Resectable; Fully Covered Metal Stent
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   3/17 (17.65%)   3/16 (18.75%) 
Gastrointestinal disorders       
Post-ERCP Pancreatitis  0/21 (0.00%)  3/17 (17.65%)  3/16 (18.75%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Timothy Gardner
Organization: Dartmouth-Hitchcock Medical Center
Phone: 603-650-6472
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01038713     History of Changes
Other Study ID Numbers: 2009-01
First Submitted: December 23, 2009
First Posted: December 24, 2009
Results First Submitted: June 9, 2016
Results First Posted: June 22, 2016
Last Update Posted: June 23, 2016