SEMS
A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Sponsor study identifier
interventional
1,075
1 country
1
Study Start
October 1, 2015
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 18, 2015
Actual (reported)October 1, 2015
Actual (reported)March 18, 2021
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.
During procedure
To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.
periprocedural and 30 days
ERCP with ES before biliary fully covered SEMS placement.
ERCP without ES before biliary fully covered SEMS placement.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
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.
First Submitted
August 18, 2015
First Posted
March 18, 2021
Study Start
October 1, 2015
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 21, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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