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

A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04805450

Acronym

SEMS

Enrollment

1075

Registered

2021-03-18

Start date

2015-10-01

Completion date

2023-12-31

Last updated

2023-03-21

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

Conditions

Malignant Bile Duct Obstruction

Brief summary

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.

Interventions

PROCEDUREES before fully covered SEMS placement

PROCEDUREno ES before fully covered SEMS placement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.	During procedure

Secondary

Measure	Time frame
To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.	periprocedural and 30 days

Countries

Italy

Contacts

Primary ContactAndrea Anderloni, MD, PhD

andrea.anderloni@humanitas.it00390282247308

Outcome results

None listed

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