Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction (SEMS)

Istituto Clinico Humanitas

Status: Enrolling

Conditions: Malignant Bile Duct Obstruction

Treatments: Procedure: no ES before fully covered SEMS placement; Procedure: ES before fully covered SEMS placement

Study type: Interventional

Funder types: Other

Identifiers

NCT04805450

ES vs noES-1

Details and patient eligibility

About

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.

Enrollment: 1,075 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,075 participants in 2 patient groups

ES before SEMS placement

Active Comparator group

Description:

ERCP with ES before biliary fully covered SEMS placement.

Treatment:

Procedure: ES before fully covered SEMS placement

no ES before SEMS placement

Active Comparator group

Description:

ERCP without ES before biliary fully covered SEMS placement.

Treatment:

Procedure: no ES before fully covered SEMS placement