Trial Outcomes & Findings for Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures (NCT NCT01238900)

NCT ID: NCT01238900

Last Updated: 2015-10-02

Results Overview

Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.

• Recruitment status: COMPLETED
• Target enrollment: 23 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-10-02

Participant Flow

Participant milestones

Measure	Benign Biliary Strictures Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
6 Months Post Stent Placement STARTED	23
6 Months Post Stent Placement COMPLETED	23
6 Months Post Stent Placement NOT COMPLETED	0
<12 Months Post Stent Removal STARTED	23
<12 Months Post Stent Removal COMPLETED	18
<12 Months Post Stent Removal NOT COMPLETED	5

Reasons for withdrawal

Measure	Benign Biliary Strictures Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
<12 Months Post Stent Removal Lost to Follow-up	4
<12 Months Post Stent Removal persistent stricture after stenting	1

Baseline Characteristics

Evaluation of the Use of Metal Stents as Part of the Treatment of Benign Biliary Strictures

Baseline characteristics by cohort

Measure	Benign Biliary Strictures n=23 Participants Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
Age, Customized	60 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Stricture etiology Chronic pancreatitis (CP)	14 participants n=5 Participants
Stricture etiology Orthotopic liver transplantation (OLT)	4 participants n=5 Participants
Stricture etiology Idiopathic	4 participants n=5 Participants
Stricture etiology Gallstone related	1 participants n=5 Participants
number of participants with history of prior stenting number with prior stenting	13 participants n=5 Participants
number of participants with history of prior stenting number with no history of stenting	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Of the 23 participants that entered the study, 22 saw short-term success. The population consisted of 14 Chronic pancreatitis patients, 4 postorthotopic liver transplant patients, and 5 others.

Short-term success was defined as resolution of the stricture as documented by rapid drainage of contrast out of the proximal biliary tree and easy passage of stone extraction balloon inflated to the size of the proximal bile duct. If the biliary stricture had resolved at the 6-month follow-up ERCP, patients were classified as short-term success. If stricture was not resolved at 6-month ERCP then a new SEMS was placed; if the stricture had resolved at the time of the second stent removal, the patient was also classified as short-term success.

Outcome measures

Measure	Benign Biliary Strictures n=23 Participants Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
Short Term Success Rate in the Resolution of Biliary Strictures Overall	22 participants
Short Term Success Rate in the Resolution of Biliary Strictures Chronic pancreatitis (CP)	14 participants
Short Term Success Rate in the Resolution of Biliary Strictures Orthotopic liver transplantation (OLT)	3 participants
Short Term Success Rate in the Resolution of Biliary Strictures All others	5 participants

PRIMARY outcome

Timeframe: at least 12 months after stent removal

Population: Per-protocol analysis, the 18 participants available for long term success follow-up consisted of: 11 with CP, 3 with OLT, and 4 others. Intention to treat analysis of long-term success consisted of 22 overall patients, 12 CP patients, 3 OLT patients, and 7 other patients. This analysis included all patients lost to follow-up as long-term failures.

Long-term success was defined as no clinical evidence of recurrence of the biliary stricture during the follow-up period as documented by laboratory findings or imaging and no further need for further endoscopic or surgical interventions.

Outcome measures

Measure	Benign Biliary Strictures n=18 Participants Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
Long-term Success Rate in Resolution of Biliary Strictures All others	4 participants
Long-term Success Rate in Resolution of Biliary Strictures Overall	15 participants
Long-term Success Rate in Resolution of Biliary Strictures Chronic pancreatitis (CP)	8 participants
Long-term Success Rate in Resolution of Biliary Strictures Orthotopic liver transplantation (OLT)	3 participants

SECONDARY outcome

Timeframe: At time of procedure

The average number of ERCPs performed per patient required for resolution of benign strictures.

Outcome measures

Measure	Benign Biliary Strictures n=23 Participants Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
Number of Endoscopic Treatments Per Patient	2.4 endoscopic treatments Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: at time of procedure

The ease of stent removal was graded on a 4-point scale (with ease, mild difficulty, significant difficulty, and failed).

Outcome measures

Measure	Benign Biliary Strictures n=23 Participants Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
Ease of Stent Removal With ease	21 participants
Ease of Stent Removal Mild difficulty	0 participants
Ease of Stent Removal Significant difficulty	2 participants
Ease of Stent Removal Failed	0 participants

SECONDARY outcome

Timeframe: up to 12 months

Population: Stent migration was seen in 9/23 patients (5 downstream, 4 upstream). It was without clinical complications except in one case. Post-procedure pain experienced by 1 patient was effectively treated by downgrading the stent size to a smaller diameter.

Adverse events were defined and graded using the 2010 American Society for Gastrointestinal Endoscopy consensus criteria

Outcome measures

Measure	Benign Biliary Strictures n=23 Participants Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
Frequency and Severity of Adverse Events (Including Stent Migration) Downstream Stent Migration	5 participants
Frequency and Severity of Adverse Events (Including Stent Migration) Postprocedure pain due to expansion force of SEMS	1 participants
Frequency and Severity of Adverse Events (Including Stent Migration) Complications during stent placement	0 participants
Frequency and Severity of Adverse Events (Including Stent Migration) Complications during stent removal	0 participants
Frequency and Severity of Adverse Events (Including Stent Migration) upstream stent migration	4 participants

Adverse Events

Benign Biliary Strictures

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Benign Biliary Strictures n=23 participants at risk Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
Gastrointestinal disorders stent migration	39.1% 9/23 • Number of events 9 • 7.5 months Stent migration
Gastrointestinal disorders abdominal pain	4.3% 1/23 • Number of events 1 • 7.5 months Stent migration

Additional Information

Dr. Peter V. Draganov

University of Florida

Phone: (352) 273-9472

Email: Peter.Draganov@medicine.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place