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

Primary Purpose

Malignant Bile Duct Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ES before fully covered SEMS placement
no ES before fully covered SEMS placement
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Bile Duct Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • 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

Sites / Locations

  • Istituto Clinico HumanitasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ES before SEMS placement

no ES before SEMS placement

Arm Description

ERCP with ES before biliary fully covered SEMS placement.

ERCP without ES before biliary fully covered SEMS placement.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2015
Last Updated
March 20, 2023
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT04805450
Brief Title
Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Acronym
SEMS
Official Title
A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Bile Duct Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1075 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ES before SEMS placement
Arm Type
Active Comparator
Arm Description
ERCP with ES before biliary fully covered SEMS placement.
Arm Title
no ES before SEMS placement
Arm Type
Active Comparator
Arm Description
ERCP without ES before biliary fully covered SEMS placement.
Intervention Type
Procedure
Intervention Name(s)
ES before fully covered SEMS placement
Intervention Type
Procedure
Intervention Name(s)
no ES before fully covered SEMS placement
Primary Outcome Measure Information:
Title
To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.
Time Frame
periprocedural and 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Anderloni, MD, PhD
Phone
00390282247308
Email
andrea.anderloni@humanitas.it
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
22297801
Citation
Dumonceau JM, Tringali A, Blero D, Deviere J, Laugiers R, Heresbach D, Costamagna G; European Society of Gastrointestinal Endoscopy. Biliary stenting: indications, choice of stents and results: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline. Endoscopy. 2012 Mar;44(3):277-98. doi: 10.1055/s-0031-1291633. Epub 2012 Feb 1.
Results Reference
background
PubMed Identifier
18027045
Citation
Simmons DT, Petersen BT, Gostout CJ, Levy MJ, Topazian MD, Baron TH. Risk of pancreatitis following endoscopically placed large-bore plastic biliary stents with and without biliary sphincterotomy for management of postoperative bile leaks. Surg Endosc. 2008 Jun;22(6):1459-63. doi: 10.1007/s00464-007-9643-8. Epub 2007 Nov 20.
Results Reference
background
PubMed Identifier
18285718
Citation
Artifon EL, Sakai P, Ishioka S, Marques SB, Lino AS, Cunha JE, Jukemura J, Cecconello I, Carrilho FJ, Opitz E, Kumar A. Endoscopic sphincterotomy before deployment of covered metal stent is associated with greater complication rate: a prospective randomized control trial. J Clin Gastroenterol. 2008 Aug;42(7):815-9. doi: 10.1097/MCG.0b013e31803dcd8a.
Results Reference
background
PubMed Identifier
15069728
Citation
Giorgio PD, Luca LD. Comparison of treatment outcomes between biliary plastic stent placements with and without endoscopic sphincterotomy for inoperable malignant common bile duct obstruction. World J Gastroenterol. 2004 Apr 15;10(8):1212-4. doi: 10.3748/wjg.v10.i8.1212.
Results Reference
background
PubMed Identifier
25320543
Citation
Cui PJ, Yao J, Zhao YJ, Han HZ, Yang J. Biliary stenting with or without sphincterotomy for malignant biliary obstruction: a meta-analysis. World J Gastroenterol. 2014 Oct 14;20(38):14033-9. doi: 10.3748/wjg.v20.i38.14033.
Results Reference
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Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

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