Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
NCT ID: NCT04805450
Last Updated: 2023-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1075 participants
INTERVENTIONAL
2015-10-01
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ES before SEMS placement
ERCP with ES before biliary fully covered SEMS placement.
ES before fully covered SEMS placement
no ES before SEMS placement
ERCP without ES before biliary fully covered SEMS placement.
no ES before fully covered SEMS placement
Interventions
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ES before fully covered SEMS placement
no ES before fully covered SEMS placement
Eligibility Criteria
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Inclusion Criteria
* Malignant bile duct obstruction
* Signed written informed consent
* Age \> 18
Exclusion Criteria
* Pregnancy or lactation
* Suspected perforation of the GI tract
* Anatomical alterations due to previous surgery (Billroth surgery)
* Coagulation alterations
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Michele Tedeschi
MD
Locations
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Istituto Clinico Humanitas
Rozzano, Milano, Italy
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ES vs noES-1
Identifier Type: -
Identifier Source: org_study_id
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