A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction (ES vs noES-1)
Phase: NA
Conditions: Bile Duct Obstruction
Sponsor: Istituto Clinico Humanitas

 
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A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY COMPARING 
SEMS PLACEMENT WITH AND WITHOUT BILIARY 
SPHINCTERECTOMY IN PATIENTS WITH MALIGNANT BILIARY 
OBSTRUCTION 
 
 
ES vs noES-1 
Version 3 (06.07.15) 
 
 
 
  
 
 
 
 

 
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1 Summary   
 
Title  
A PROSPECTIVE, RANDOMIZED, 
MULTICENTER STUDY COMPARING SEMS 
PLACEMENT WITH AND WITHOUT BILIARY 
SPHINCTERECTOMY IN PATIENTS WITH 
MALIGNANT BILIARY OBSTRUCTION 
 
 
 
Study coordinator: Dr Anderloni  
Protocol identifying number  
 
ES vs noES-1 
 
Protocol version date 
Version 3 (06.07.15) 
Background and rationale 
 
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. EST may facilitate insertion of self expandable metal stent 
(SEMS) and also help avert the development of pancreatitis from 
stent-related occlusion of the pancreatic duct.  On the other hand, 
ES is also independently associated with pancreatitis, bleeding, 
and perforation. [2-5]. 
Latest European guidelines indicate that EST is not necessary for 
inserting single plastic or metal biliary stents [1], nevertheless a 
more recent meta analysis showed that ES may decrease the rate 
of PEP [5]. 
 
 
 
Population and patient selection 
criteria 
 
All 
the 
patient 
referred 
for 
endoscopic 
retrograde 
cholangiopancreatography (ERCP) due to malignant bile duct 
obstruction. 
 
Study design and study duration 
 
Prospective randomized, multicenter study. 
18 months. 
 
Description of study 
treatment/product/intervention 
 
All the patients will be randomly assigned to undergo ERCP with 
(Group A) or without (Group B) ES before biliary SEMS 
placement. 
All the endoscopic procedures will be performed by experienced 
endoscopist in the endoscopy suite. 
All the procedure will be conducted under deep sedation. 
SEMS placed will be fully covered. 
 
 

 
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Objectives 
To assess the need for EST before SEMS placement in patients 
with malignant bile duct obstruction. 
To evaluate immediate (periprocedural) and delayed (30 days) 
post ERCP complications including pancreatitis,  SEMS 
migration, bleeding and perforation. 
 
Statistical methods, data analysis 
 
A sample size analysis to detect superiority at 5% significance 
level and a power of 80%  showed that 500 patients had to be 
enrolled in each group. 
Continuous variables such age will be reported in terms of their 
mean and range, and t-test will be done to test their main 
difference.  
X square test or Fisher exact test will be carried out for statistical 
analysis to compare rates of total complications between the two 
groups and rates of pancreatitis, bleeding, stent migration and 
perforation. 
Wilcoxon Mann-Withney test will be used for comparison of 
means between 2 continuous variables. A single-tailed P value of 
less than 0,05 is considered significant.  
 
 
 
Study time table 
 
Project starting date: 15-7-2015 
Project completion of patients accrual: 15-10-2016 
Project completion of data collection: 15-11-2016 
Project data analysis: 15-2-2017 
Project presentation of scientific report: 15-4-2017