Bile Duct ObstructionNCT03628001
A Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
A study testing ERCP in people with Bile Duct Obstruction, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Obstruction
- What is being tested?
- ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2015to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for endoscopic retrograde cholangiopancreatography
- Malignant bile duct obstruction
- Signed written informed consent
- Age > 18
Who cannot join
- Inability to provide inform consent
- Pregnancy or lactation
- Suspected perforation of the GI tract
- Anatomical alterations due to previous surgery (Billroth surgery)
- Coagulation alterations
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Repici, MD, +390282247493, alessadro.repici@humanitas.it
Alessandro Repici, MD
About this study
Official title: 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.
Read more
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
- Conditions
- Bile Duct Obstruction
- Being tested
- ERCP
- Keywords
- Endoscopic retrograde cholangiopancreatography (ERCP), Distal malignant bile duct obstruction, Sphincterotomy
- Medical subject headings
- Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPProcedure or surgery
Pts will be randomized with or without sphinterectomy.
| Study group | Role | What they receive |
|---|---|---|
| A | Other | ERCP with (Group A) ES before biliary SEMS placement Receives: Procedure: ERCP |
| B | Other | ERCP without (Group B) ES before biliary SEMS placement Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of complications after ERCP.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628001
- Sponsor's protocol ID
- 1442
- Status last verified
- Sep 2022
- First submitted
- 3 Apr 2018
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction (ES vs noES-1)
- ClinicalTrials.gov ID
- NCT03628001
- Acronym / sponsor ID
- 1442
- Conditions
- Bile Duct Obstruction
- Keywords
- Endoscopic retrograde cholangiopancreatography (ERCP), Distal malignant bile duct obstruction, Sphincterotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: ERCPERCP with (Group A) ES before biliary SEMS placement |
| B | Other | Procedure: ERCPERCP without (Group B) ES before biliary SEMS placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred for endoscopic retrograde cholangiopancreatography
- Malignant bile duct obstruction
- Signed written informed consent
- Age > 18
Key exclusion criteria (5 listed)
- Inability to provide inform consent
- Pregnancy or lactation
- Suspected perforation of the GI tract
- Anatomical alterations due to previous surgery (Billroth surgery)
- Coagulation alterations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERCPPts will be randomized with or without sphinterectomy. | Procedure or surgery | A, B |
Primary outcome
Number and type of complications after ERCP.
Time frame: 18 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERCP in people with Bile Duct Obstruction, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Anderloni, MD (0039-02-82247308, andrea.anderloni@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and type of complications after ERCP. (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.