Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis

Self-expandable, Fully Covered Metal Stents in Biliary Strictures Due to Chronic Pancreatitis Not Responding to Plastic Stenting: a Prospective Study With Two Years Follow-up.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01457092

Enrollment

Registered

2011-10-21

Start date

2007-01-31

Completion date

2009-09-30

Last updated

2015-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Biliary Strictures, Chronic Pancreatitis

Keywords

benign biliary strictures, chronic pancreatitis

Brief summary

The purpose of the study was to analyze the resolution rate of benign biliary strictures due to chronic pancreatitis after temporary insertion of unflared-ends and flared-ends fully covered self-expandable metal stents.

Detailed description

Endoscopic treatment of benign biliary strictures include the placement of plastic stents or Self-Expandable Metal Stents. Long term results of placement of a single plastic stent are disappointing. Better results have been obtained by endoscopic insertion of multiple plastic stents. Biliary Self-Expandable Metal Stents used for malignant strictures are uncovered or partially covered with a plastic coating. More recently, fully covered SEMS have been developed and are now available on the market and due to their removability are proposed also for benign indications. Uncovered and partially covered biliary Self-Expandable Metal Stents for chronic pancreatitis-related benign biliary strictures on long-term may clog due to tissue ingrowth through the uncovered meshes. Removable fully covered Self-Expandable Metal Stents seem to be an attractive option for CP-related BBS, but scarce data are available in the literature. The investigators conducted a feasibility, prospective, tertiary single-centre trial to investigate the durable resolution of chronic pancreatitis-related benign biliary strictures after temporary insertion of FC SEMS with unflared-ends and flared-ends.

Interventions

DEVICEFC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)

Placement of self-expandable metal stents

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. age ≥18 years, 2. symptomatic (persistent cholestasis, jaundice, cholangitis) common bile duct strictures secondary to CP, that persist 3 months or more after placement of a single 10 French plastic stent and 3. patient unfit for surgery (portal cavernomatosis, comorbidities) or patient refusal of surgery.

Exclusion criteria

1. benign biliary strictures secondary to compression from a pancreatic pseudocyst; 2. patients with associated pancreatic neoplasia 3. ongoing alcohol abuse (ethanol \> 80 g/day).

Design outcomes

Primary

Measure	Time frame
Stricture dilatation	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026