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

March 20, 2023 updated by: Michele Tedeschi, Istituto Clinico Humanitas

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1075

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ES before SEMS placement
ERCP with ES before biliary fully covered SEMS placement.
Procedure: ES before fully covered SEMS placement
Active Comparator: no ES before SEMS placement
ERCP without ES before biliary fully covered SEMS placement.
Procedure: no ES before fully covered SEMS placement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES vs noES-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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