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

Catholic University of the Sacred Heart

Status: Completed

Conditions: Chronic Pancreatitis; Benign Biliary Strictures

Treatments: Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)

Study type: Interventional

Funder types: Other

Identifiers

NCT01457092

A/1530/2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

FC Nitinol SEMS

Experimental group

Description:

FC Nitinol SEMS

Treatment:

Device: FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)