NCT04805450

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,075

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5.5 years until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

8.3 years

First QC Date

August 18, 2015

Last Update Submit

March 20, 2023

Conditions

Malignant Bile Duct Obstruction

Outcome Measures

Primary Outcomes (1)

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

    During procedure

Secondary Outcomes (1)

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

    periprocedural and 30 days

Study Arms (2)

ES before SEMS placement

ACTIVE COMPARATOR

ERCP with ES before biliary fully covered SEMS placement.

Procedure: ES before fully covered SEMS placement

no ES before SEMS placement

ACTIVE COMPARATOR

ERCP without ES before biliary fully covered SEMS placement.

Procedure: no ES before fully covered SEMS placement

Interventions

ES before fully covered SEMS placementPROCEDURE
ES before SEMS placement
no ES before fully covered SEMS placementPROCEDURE
no ES before SEMS placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for endoscopic retrograde cholangiopancreatography
  • Malignant bile duct obstruction
  • Signed written informed consent
  • Age \> 18

You may not qualify if:

  • Inability to provide inform consent
  • Pregnancy or lactation
  • Suspected perforation of the GI tract
  • Anatomical alterations due to previous surgery (Billroth surgery)
  • Coagulation alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22297801BACKGROUND

  • 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.

    PMID: 18027045BACKGROUND

  • 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.

    PMID: 18285718BACKGROUND

  • 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.

    PMID: 15069728BACKGROUND

  • 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.

    PMID: 25320543BACKGROUND

Central Study Contacts

Andrea Anderloni, MD, PhD

CONTACT

00390282247308andrea.anderloni@humanitas.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 18, 2015

First Posted

March 18, 2021

Study Start

October 1, 2015

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Locations

IT(1)