A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00433771
• Collaborator: (none)
• Enrollment: 74
• Locations: 10
• Arm: 1
• Duration (Months): 14
• Patients Per Site: 7.4
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The overall objective of this study is to assess the functionality of the WallFlex™ Biliary Fully-covered stent as a palliative treatment for malignant bile duct obstruction.

Condition or Disease	Intervention/Treatment	Phase
Cholestasis, Extrahepatic	Device: WallFlex™ Biliary Fully Covered Metal Stent placement	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Single Arm, Prospective Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WallFlex Biliary Fully Covered stent Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent	Device: WallFlex™ Biliary Fully Covered Metal Stent placement; Implantable metal biliary stent intended for use in the palliative treatment of biliary strictures produced by malignant neoplasms. The stent is fully covered with a polymer to reduce the potential for tumor ingrowth into the stent.

Outcome Measures

Primary Outcome Measures

1. Adequate Clinical Palliation of the Biliary Obstruction [6 months]

   Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.

Secondary Outcome Measures

1. Technical Success [At treatment]

   Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.

2. Ability to Successfully Remove a Stent Upon Removal Attempt [6 months]

   The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.

3. Re-interventions [Until 6 months or death]

   Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.

4. Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms [1 Month]

   Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.

5. Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms [3 months]

   Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.

6. Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms [6 months]

   Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.

7. Bilirubin Level Reduction [1 month]

   Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.

8. Stent Patency at 1 Month [1 month]

   Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.

9. Stent Patency at 3 Months [3 Months]

   Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).

10. Stent Patency at 6 Months [6 Months]

    Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).

11. Time to Stent Occlusion [Until 6 Months or death]

    Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.

12. Number of Device-Related Adverse Events [Until 6 months or death]

    Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 or older

• Clinical symptoms of biliary obstruction

• Inoperable extrahepatic biliary obstruction by any malignant process

• Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

• Participation in an Investigational Study within 90 days prior to date of patient consent

• Strictures that cannot be dilated enough to pass the delivery system

• Perforation of any duct within the biliary tree

• Presence of a metal biliary stent

• Presence of any esophageal or duodenal stent

• Patients for whom endoscopic procedures are contraindicated

• Patients with known sensitivity to any components of the stent or delivery system

• Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver

• Patients with an anticipated life expectancy of < 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Pacific Medical Center	San Francisco	California	United States	94115
2	Univ. of Colorado Health Sciences	Aurora	Colorado	United States	80010
3	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
4	Mayo Clinic	Rochester	Minnesota	United States	55905
5	Washington University School of Medicine	St. Louis	Missouri	United States	63110
6	Duke University Med Center	Durham	North Carolina	United States	27710
7	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
8	MD Anderson Cancer Center	Houston	Texas	United States	77030
9	Univ. of VA Medical Center	Charlottesville	Virginia	United States	800708
10	Virginia Mason Seattle Main Clinic	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Bret Petersen, MD, Mayo Clinic, Rochester, MN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00433771
• Other Study ID Numbers: ENDO-WALLFLEX-BIL-PALL-001U; E7009
• First Posted: Feb 12, 2007
• Last Update Posted: Jun 29, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Malignant; Cholestasis, Extrahepatic; Biliary obstruction
• Additional relevant MeSH terms: Cholestasis; Cholestasis, Extrahepatic

Study Results

Participant Flow

Recruitment Details	Enrollment complete

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Period Title: Overall Study
STARTED	74
COMPLETED	55
NOT COMPLETED	19

Baseline Characteristics

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Overall Participants	58
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 34.5%
>=65 years	38 65.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.91 (14.35)
Sex: Female, Male (Count of Participants)
Female	28 48.3%
Male	30 51.7%
Region of Enrollment (participants) [Number]
United States	58 100%

Outcome Measures

1. Primary Outcome

Title	Adequate Clinical Palliation of the Biliary Obstruction
Description	Adequate clinical palliation of the biliary obstruction as demonstrated by the absence of stent occlusion within 6 month follow up or prior to death, whichever comes first in the evaluable subject cohort of 55 patients.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Per protocol, assessment of the primary endpoint was performed on the evaluable cohort, defined as group of patients who signed the Informed Consent Form, met eligibility criteria, received a stent and had at least one week of follow up.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	55
Number [participants]	54 93.1%

2. Secondary Outcome

Title	Technical Success
Description	Technical success is defined as the ability to deploy the stent in satisfactory position across the stricture. It was assessed in the intent-to-treat cohort.
Time Frame	At treatment

Outcome Measure Data

Analysis Population Description

Device Safety and Technical Success were evaluated for the 58 intent-to-treat patients

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	58
Number [participants]	57 98.3%

3. Secondary Outcome

Title	Ability to Successfully Remove a Stent Upon Removal Attempt
Description	The ability to successfully remove a stent upon a removal attempt was defined as removal without any clinically-significant complications or technical difficulties.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

2 patients of the evaluable cohort (n=55) were assessed for success of stent removal without any complications/technical difficulties.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	2
Number [Participants]	2 3.4%

4. Secondary Outcome

Title	Re-interventions
Description	Per the study protocol, re-intervention was defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage after insertion of the initial stent.
Time Frame	Until 6 months or death

Outcome Measure Data

Analysis Population Description

The re-intervention rate was assessed in the evaluable cohort of 55 patients.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	55
Number [Participant]	1

5. Secondary Outcome

Title	Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms
Description	Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 1 month after stent treatment.
Time Frame	1 Month

Outcome Measure Data

Analysis Population Description

49 out of 55 evaluable subjects reached the 1-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	49
Number [Participants]	45 77.6%

6. Secondary Outcome

Title	Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Description	Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 3 months after stent treatment.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

34 out of 55 evaluable subjects reached the 3-Month Follow Up visit and were evaluated for reduction of biliary obstruction symptoms compared to baseline.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	34
Number [Participants]	33 56.9%

7. Secondary Outcome

Title	Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms
Description	Clinical success was defined as the reduction of biliary obstruction symptoms after treatment with the device.Symptoms included jaundice,pruritis,right upper quadrant abdominal pain,nausea,vomiting,fever and dark urine.For each patient,a total number of symptoms at baseline and at all post-treatment visits were recorded.Reduction in obstruction symptoms was defined as having a lower total number of symptoms at a post-treatment follow up visit compared to baseline.Here we report the number of subjects with a reduced total number of biliary obstructive symptoms at 6 months after stent treatment.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

23 out of 55 evaluable subjects reached the 6-Month follow up visit and were assessed for reduction of biliary obstructive symptoms compared to baseline.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	23
Number [Participants]	23 39.7%

8. Secondary Outcome

Title	Bilirubin Level Reduction
Description	Total bilirubin levels at 1 month follow-up were compared to initial bilirubin levels. Bilirubin level reduction was defined as total bilirubin levels being below 3mg/dl, or reduced by >30% if the initial baseline value was greater than 3mg/dl.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

45 out of 55 evaluable patients reported a baseline and a Month 1 total bilirubin level and were therefore analyzed for bilirubin levels reduction.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	45
Number [Participants]	44 75.9%

9. Secondary Outcome

Title	Stent Patency at 1 Month
Description	Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a total bilirubin level of less than 3mg/dl. Patency evaluations at the Month 1 visit were done on those patients with both a total bilirubin level and assessment of biliary obstructive symptoms.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

45 out of 55 evaluable patients had both bilirubin and obstructive symptom assessment at Month 1.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	45
Number [Participants]	44 75.9%

10. Secondary Outcome

Title	Stent Patency at 3 Months
Description	Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 3 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 3).
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

34 patients reached the Month 3 follow up point and were evaluated for stent patency.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	34
Number [Participants]	31 53.4%

11. Secondary Outcome

Title	Stent Patency at 6 Months
Description	Per the protocol, stent patency was defined as lack of obstructive symptoms and/or a normal total bilirubin level. Patency evaluations at Month 6 were done on those patients with an assessment of biliary obstructive symptoms (bilirubin levels were not measured at Month 6).
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

23 patients reached the Month 6 follow up point and were evaluated for stent patency.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	23
Number [Participants]	21 36.2%

12. Secondary Outcome

Title	Time to Stent Occlusion
Description	Time to stent occlusion(measured in days since stent placement) was recorded for any subjects who experienced occlusion.
Time Frame	Until 6 Months or death

Outcome Measure Data

Analysis Population Description

Only 1 subject experienced stent occlusion during the study.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	1
Number [Days]	142

13. Secondary Outcome

Title	Number of Device-Related Adverse Events
Description	Adverse Events reported during the trial were evaluated for their device-and procedure-relatedness and severity in order to assess device safety. An adverse event was defined as any untoward medical occurance in a study participant.
Time Frame	Until 6 months or death

Outcome Measure Data

Analysis Population Description

The intent-to-treat cohort of 58 patients was used for this analysis. Of all the events reported for this population, only 6 events were reported as device-related.

Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Measure Participants	58
Number [Events]	6

Adverse Events

Time Frame	11 months
Arm/Group Title	WallFlex Biliary Fully Covered Stent
Arm/Group Description	Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
All Cause Mortality
	WallFlex Biliary Fully Covered Stent
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	WallFlex Biliary Fully Covered Stent
	Affected / at Risk (%)	# Events
Total	45/58 (77.6%)
Blood and lymphatic system disorders
Lymphadenopathy mediastinal	1/58 (1.7%)	1
Cardiac disorders
Cardiac Failure Congestive	1/58 (1.7%)	1
Myocardial Infarction	1/58 (1.7%)	1
Gastrointestinal disorders
Abdominal Pain	1/58 (1.7%)	1
Abdominal pain upper	3/58 (5.2%)	3
Constipation	1/58 (1.7%)	1
Diverticular Perforation	1/58 (1.7%)	1
Enterovesical Fistula	1/58 (1.7%)	1
Nausea	2/58 (3.4%)	2
Obstruction gastric	1/58 (1.7%)	1
Pancreatitis	1/58 (1.7%)	1
Rectal hemorrhage	1/58 (1.7%)	1
Upper gastrointestinal hemorrhage	1/58 (1.7%)	1
Vomitting	1/58 (1.7%)	1
General disorders
Asthenia	2/58 (3.4%)	2
Chest pain	2/58 (3.4%)	2
Death	1/58 (1.7%)	1
Oedema peripheral	1/58 (1.7%)	1
Pain	1/58 (1.7%)	1
Pyrexia	3/58 (5.2%)	3
Hepatobiliary disorders
Cholangitis	1/58 (1.7%)	1
Cholecystitis	2/58 (3.4%)	2
Gall bladder perforation	1/58 (1.7%)	1
Hepatic cirrhosis	1/58 (1.7%)	1
Infections and infestations
Abscess	1/58 (1.7%)	1
Bacteraemia	1/58 (1.7%)	1
Cellulitis	1/58 (1.7%)	1
Injury, poisoning and procedural complications
Posprocedural hemorrhage	1/58 (1.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic	1/58 (1.7%)	1
Lung cancer metastatic	1/58 (1.7%)	1
Malignant ascites	1/58 (1.7%)	1
Metastatic neoplasm	1/58 (1.7%)	1
Pancreatic Carcinoma	18/58 (31%)	18
Pancreatic Carcinoma Metastatic	8/58 (13.8%)	8
Respiratory, thoracic and mediastinal disorders
Dyspnoea	3/58 (5.2%)	3
Pneumothorax	1/58 (1.7%)	1
Pulmonary embolism	3/58 (5.2%)	3
Respiratory failure	1/58 (1.7%)	1
Vascular disorders
Deep vein thrombosis	4/58 (6.9%)	4
Hypertension	1/58 (1.7%)	1
Other (Not Including Serious) Adverse Events
	WallFlex Biliary Fully Covered Stent
	Affected / at Risk (%)	# Events
Total	38/58 (65.5%)
Gastrointestinal disorders
Abdominal pain	6/58 (10.3%)	6
Ascites	5/58 (8.6%)	5
Constipation	4/58 (6.9%)	4
Nausea	6/58 (10.3%)	6
Vomitting	3/58 (5.2%)	3
General disorders
Oedema peripheral	3/58 (5.2%)	3
Pyrexia	3/58 (5.2%)	3
Musculoskeletal and connective tissue disorders
Back pain	5/58 (8.6%)	5
Respiratory, thoracic and mediastinal disorders
Pleural effusion	3/58 (5.2%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.