Malignant Bile Duct ObstructionSEMSNCT04805450
Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
A study testing ES before fully covered SEMS placement and no ES before fully covered SEMS placement in people with Malignant Bile Duct Obstruction, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
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]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Bile Duct Obstruction
- What is being tested?
- ES before fully covered SEMS placement and no ES before fully covered SEMS placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,075 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 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
Istituto Clinico Humanitas
Rozzano, Milano, 20089
About this study
Official title: A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
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.
- Conditions
- Malignant Bile Duct Obstruction
- Being tested
- ES before fully covered SEMS placement, no ES before fully covered SEMS placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES before fully covered SEMS placementProcedure or surgery
no ES before fully covered SEMS placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ES before SEMS placement | Active comparator | ERCP with ES before biliary fully covered SEMS placement. Receives: Procedure: ES before fully covered SEMS placement |
| no ES before SEMS placement | Active comparator | ERCP without ES before biliary fully covered SEMS placement. Receives: Procedure: no ES before fully covered SEMS placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.
Measured: During procedure
Secondary outcomes (1)
To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.
Measured: periprocedural and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start1 Oct 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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malignant Bile Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,075 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805450
- Sponsor's protocol ID
- ES vs noES-1
- Acronym
- SEMS
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2015
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22297801Simmons 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.
PubMed 18027045Artifon 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.
PubMed 18285718Giorgio 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.
PubMed 15069728Cui 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.
PubMed 25320543
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. 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 Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
- ClinicalTrials.gov ID
- NCT04805450
- Acronym / sponsor ID
- SEMS / ES vs noES-1
- Conditions
- Malignant Bile Duct Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,075 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Mar 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ES before SEMS placement | Active comparator | Procedure: ES before fully covered SEMS placementERCP with ES before biliary fully covered SEMS placement. |
| no ES before SEMS placement | Active comparator | Procedure: no ES before fully covered SEMS placementERCP without ES before biliary fully covered 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)
Key exclusion criteria (5 listed)
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 |
|---|---|---|
| ES before fully covered SEMS placement | Procedure or surgery | ES before SEMS placement |
| no ES before fully covered SEMS placement | Procedure or surgery | no ES before SEMS placement |
Primary outcome
To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.
Time frame: During procedure
1 secondary outcome
To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.
Time frame: periprocedural and 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Background: PubMed 22297801Dumonceau 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.
- Background: PubMed 18027045Simmons 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.
- Background: PubMed 18285718Artifon 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.
- Background: PubMed 15069728Giorgio 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.
- Background: PubMed 25320543Cui 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.
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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 ES before fully covered SEMS placement and no ES before fully covered SEMS placement in people with Malignant 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 Mar 2023. 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, PhD (00390282247308, andrea.anderloni@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction. (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805450, which also lists 5 linked publications.
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 Mar 2023.