Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

Istituto Clinico Humanitas1,075 enrolled

Overview

Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered \[1\]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents \[2-5\]. The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,075

Conditions

Malignant Bile Duct Obstruction

Interventions

ES before fully covered SEMS placementPROCEDURE

no ES before fully covered SEMS placementPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* Inclusion criteria * Patients referred for endoscopic retrograde cholangiopancreatography * Malignant bile duct obstruction * Signed written informed consent * Age \> 18 * Exclusion criteria * Inability to provide inform consent * Pregnancy or lactation * Suspected perforation of the GI tract * Anatomical alterations due to previous surgery (Billroth surgery) * Coagulation alterations

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milano, Italy

RECRUITING

Outcomes

Primary Outcomes

To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.

Time frame: During procedure

Secondary Outcomes

To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.

Time frame: periprocedural and 30 days

Central Contacts

Andrea Anderloni, MD, PhD

CONTACT

00390282247308 andrea.anderloni@humanitas.it

Data from ClinicalTrials.gov

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