Trial Outcomes & Findings for A Study of the WallFlex™ Biliary Fully-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction (NCT NCT00433771)

Last Updated: 2010-06-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

74 participants

Primary outcome timeframe

6 months

Results posted on

2010-06-29

Participant Flow

Enrollment complete

Participant milestones

Participant milestones
Measure	WallFlex Biliary Fully Covered Stent Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Overall Study STARTED	74
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	WallFlex Biliary Fully Covered Stent Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Overall Study screen fail	14
Overall Study Treated and later found to be ineligible	2
Overall Study Death	2
Overall Study Failure to deploy stent	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	WallFlex Biliary Fully Covered Stent n=58 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants
Age Continuous	67.91 years STANDARD_DEVIATION 14.35 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=55 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Adequate Clinical Palliation of the Biliary Obstruction	54 participants

SECONDARY outcome

Timeframe: At treatment

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

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=58 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Technical Success	57 participants

SECONDARY outcome

Timeframe: 6 months

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

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

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=2 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Ability to Successfully Remove a Stent Upon Removal Attempt	2 Participants

SECONDARY outcome

Timeframe: Until 6 months or death

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

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=55 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Re-interventions	1 Participant

SECONDARY outcome

Timeframe: 1 Month

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

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=49 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Clinical Success at 1 Month After Stent Procedure as Defined by Reduction of Biliary Obstruction Symptoms	45 Participants

SECONDARY outcome

Timeframe: 3 months

Population: 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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=34 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Clinical Success at 3 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms	33 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=23 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Clinical Success at 6 Months After Stent Procedure as Defined by the Reduction of Biliary Obstruction Symptoms	23 Participants

SECONDARY outcome

Timeframe: 1 month

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

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=45 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Bilirubin Level Reduction	44 Participants

SECONDARY outcome

Timeframe: 1 month

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

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=45 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Stent Patency at 1 Month	44 Participants

SECONDARY outcome

Timeframe: 3 Months

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

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).

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=34 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Stent Patency at 3 Months	31 Participants

SECONDARY outcome

Timeframe: 6 Months

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

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).

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=23 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Stent Patency at 6 Months	21 Participants

SECONDARY outcome

Timeframe: Until 6 Months or death

Population: Only 1 subject experienced stent occlusion during the study.

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

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=1 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Time to Stent Occlusion	142 Days

SECONDARY outcome

Timeframe: Until 6 months or death

Population: 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.

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.

Outcome measures

Outcome measures
Measure	WallFlex Biliary Fully Covered Stent n=58 Participants Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Number of Device-Related Adverse Events	6 Events

Adverse Events

WallFlex Biliary Fully Covered Stent

Serious events: 45 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	WallFlex Biliary Fully Covered Stent n=58 participants at risk Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Gastrointestinal disorders Abdominal Pain	1.7% 1/58 • Number of events 1 • 11 months
Gastrointestinal disorders Abdominal pain upper	5.2% 3/58 • Number of events 3 • 11 months
Infections and infestations Abscess	1.7% 1/58 • Number of events 1 • 11 months
General disorders Asthenia	3.4% 2/58 • Number of events 2 • 11 months
Infections and infestations Bacteraemia	1.7% 1/58 • Number of events 1 • 11 months
Cardiac disorders Cardiac Failure Congestive	1.7% 1/58 • Number of events 1 • 11 months
Infections and infestations Cellulitis	1.7% 1/58 • Number of events 1 • 11 months
General disorders Chest pain	3.4% 2/58 • Number of events 2 • 11 months
Hepatobiliary disorders Cholangitis	1.7% 1/58 • Number of events 1 • 11 months
Hepatobiliary disorders Cholecystitis	3.4% 2/58 • Number of events 2 • 11 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	1.7% 1/58 • Number of events 1 • 11 months
Gastrointestinal disorders Constipation	1.7% 1/58 • Number of events 1 • 11 months
General disorders Death	1.7% 1/58 • Number of events 1 • 11 months
Vascular disorders Deep vein thrombosis	6.9% 4/58 • Number of events 4 • 11 months
Gastrointestinal disorders Diverticular Perforation	1.7% 1/58 • Number of events 1 • 11 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.2% 3/58 • Number of events 3 • 11 months
Gastrointestinal disorders Enterovesical Fistula	1.7% 1/58 • Number of events 1 • 11 months
Hepatobiliary disorders Gall bladder perforation	1.7% 1/58 • Number of events 1 • 11 months
Hepatobiliary disorders Hepatic cirrhosis	1.7% 1/58 • Number of events 1 • 11 months
Vascular disorders Hypertension	1.7% 1/58 • Number of events 1 • 11 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	1.7% 1/58 • Number of events 1 • 11 months
Blood and lymphatic system disorders Lymphadenopathy mediastinal	1.7% 1/58 • Number of events 1 • 11 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	1.7% 1/58 • Number of events 1 • 11 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	1.7% 1/58 • Number of events 1 • 11 months
Cardiac disorders Myocardial Infarction	1.7% 1/58 • Number of events 1 • 11 months
Gastrointestinal disorders Nausea	3.4% 2/58 • Number of events 2 • 11 months
Gastrointestinal disorders Obstruction gastric	1.7% 1/58 • Number of events 1 • 11 months
General disorders Oedema peripheral	1.7% 1/58 • Number of events 1 • 11 months
General disorders Pain	1.7% 1/58 • Number of events 1 • 11 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	31.0% 18/58 • Number of events 18 • 11 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	13.8% 8/58 • Number of events 8 • 11 months
Gastrointestinal disorders Pancreatitis	1.7% 1/58 • Number of events 1 • 11 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.7% 1/58 • Number of events 1 • 11 months
Injury, poisoning and procedural complications Posprocedural hemorrhage	1.7% 1/58 • Number of events 1 • 11 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	5.2% 3/58 • Number of events 3 • 11 months
General disorders Pyrexia	5.2% 3/58 • Number of events 3 • 11 months
Gastrointestinal disorders Rectal hemorrhage	1.7% 1/58 • Number of events 1 • 11 months
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 1/58 • Number of events 1 • 11 months
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.7% 1/58 • Number of events 1 • 11 months
Gastrointestinal disorders Vomitting	1.7% 1/58 • Number of events 1 • 11 months

Other adverse events

Other adverse events
Measure	WallFlex Biliary Fully Covered Stent n=58 participants at risk Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
Gastrointestinal disorders Abdominal pain	10.3% 6/58 • Number of events 6 • 11 months
Gastrointestinal disorders Ascites	8.6% 5/58 • Number of events 5 • 11 months
Musculoskeletal and connective tissue disorders Back pain	8.6% 5/58 • Number of events 5 • 11 months
Gastrointestinal disorders Constipation	6.9% 4/58 • Number of events 4 • 11 months
Gastrointestinal disorders Nausea	10.3% 6/58 • Number of events 6 • 11 months
General disorders Oedema peripheral	5.2% 3/58 • Number of events 3 • 11 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.2% 3/58 • Number of events 3 • 11 months
General disorders Pyrexia	5.2% 3/58 • Number of events 3 • 11 months
Gastrointestinal disorders Vomitting	5.2% 3/58 • Number of events 3 • 11 months

Additional Information

Jeremy Bolt

Boston Scientific Corporation

Phone: 508-683-4006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place