Trial Outcomes & Findings for Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures. (NCT NCT01590394)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

6 months

Results posted on

2017-10-17

Participant Flow

Patients were enrolled at Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Pancreatic Cancer Patients A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pancreatic Cancer Patients n=3 Participants A large plastic biliary stent was placed in the bile duct for bile duct obstruction.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Data were not analyzed, because there were too few subjects to make the outcome measure meaningful. Principal investigator retired before any analysis could be performed.

Outcome measures

Outcome data not reported

Adverse Events

Pancreatic Cancer Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher J. Gostout

Mayo Clinic

Phone: 507-284-7647

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place