A Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction

A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction (ES vs noES-1)

Background and rationale Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered.

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.

Latest European guidelines indicate that EST is not necessary for inserting single plastic or metal biliary stents, nevertheless a more recent meta analysis showed that ES may decrease the rate of PEP.

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.

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

Study Overview

• Status: Recruiting
• Conditions: Bile Duct Obstruction
• Intervention / Treatment: Procedure: ERCP

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Anderloni, MD; Phone Number: 0039-02-82247308; Email: andrea.anderloni@humanitas.it
• Study Contact Backup: Name: Alessandro Repici, MD; Phone Number: 0039-02-82247493; Email: alessandro.repici@hunimed.eu

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A; ERCP with (Group A) ES before biliary SEMS placement	Procedure: ERCP; Pts will be randomized with or without sphinterectomy.
Other: B; ERCP without (Group B) ES before biliary SEMS placement	Procedure: ERCP; Pts will be randomized with or without sphinterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and type of complications after ERCP.	18 Months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Sphincterotomy; Endoscopic retrograde cholangiopancreatography (ERCP); Distal malignant bile duct obstruction
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis
• Other Study ID Numbers: 1442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No