Malignant Biliary ObstructionPROMETHEUSNCT06550973
PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
A study testing pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique in people with Malignant Biliary Obstruction, run by Istituto Clinico Humanitas.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving success during therapeutic ERCP is selective biliary cannulation (SBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Biliary Obstruction
- What is being tested?
- pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Sep 2026
- 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
- Age ≥18 years
- Patients with distal malignant biliary obstruction
- Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct > 15 mm diameter.
- Difficult biliary cannulation defined as ESGE guidelines
- Agree to receive follow up phone calls
- Able to provide written informed consent
Who cannot join
- Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000 103/mm3.
- Use of anticoagulants that cannot be discontinued
- Pregnant women
- Previous ERCP or EUS-BD attempt
- Inability to sign the informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized, Multicentric Trial, PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving success during therapeutic ERCP is selective biliary cannulation (SBC). Nevertheless, SBC doesn't consistently yield favorable outcomes, even among expert endoscopists, failing in around 25% to 50% of cases with standard ERCP approach (sphincterotome and guidewire).
In such situations, depending on the endoscopist's experience and preference, various advanced techniques come into play. These encompass the double guidewire cannulation approach, needle-knife precut papillotomy or fistulotomy, and transpancreatic sphincterotomy, serving as potential rescue methods.
In recent times, the EUS-guided approach has been gaining increasing significance. Initially, it was viewed as a rescue option in cases where advanced ERCP techniques failed (5-15% of cases). More recently, it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction.
Read the detailed description
Rationale of the study Patients with distal malignant biliary obstruction have a higher risk of ERCP failure, related to the difficulty of bile duct cannulation. These patients after standard ERCP strategies failure, undergo advanced ERCP rescue strategies and in case of failure to EUS guided biliary drainage. HoweverEUS guided biliary drainage performed following the attempted advanced ERCP strategies, it may carry the risk of adverse events of advance ERCP strategies. We hypothesize that, in this setting of patients, early EUS guided biliary drainage in case of difficult biliary cannulation has a lower risk of post-procedural adverse events, as well as better overall safety and efficacy profiles. This could imply better outcomes such as for those patients who are planned to receive a chemotherapy before surgery in which a complication, such as acute pancreatitis, could delay the treatment.
- Conditions
- Malignant Biliary Obstruction
- Being tested
- pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) techniqueProcedure or surgery
Rescue techniques, such as pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique, wire-guided cannulation over a pancreatic stent and transpancreatic biliary sphincterotomy, will be used at the discretion of the endoscopist [12]. After deep cannulation, a cholangiogram to better define the characteristics of the stenosis will be done. The stent will then be inserted over a guidewire and deployed across the stenosis. All stents will be fully covered SEMSs or partially covered SEMSs of 10 mm diameter. The length of the stent will be chosen at the discretion of the endoscopist performing the procedure. A prophylactic pancreatic stent will be placed in patients who will be thought to be at high risk of post-procedure pancreatitis at the discretion of the treating endoscopist.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided biliary drainage | No intervention | EUS-guided biliary drainage will be performed using a bi-flanged lumen apposing metal stent (LAMS) mounted on an electrocautery-enhanced delivery. After EUS identification of the dilated CBD, a place without interposing vessels will be found by the endosonographer. Transduodenal puncture of the CBD will be performed directly with the LAMS that will be used to cautery the tract and enter the CBD. The diameter and length of the stent and the modality of placing the stent (under complete EUS view or with endoscopic or fluoroscopic guidance) will be chosen at the discretion of the endoscopist performing the procedure. |
| Rescue techniques | Experimental | Rescue techniques, such as pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique, wire-guided cannulation over a pancreatic stent and transpancreatic biliary sphincterotomy, will be used at the discretion of the endoscopist [12]. After deep cannulation, a cholangiogram to better define the characteristics of the stenosis will be done. The stent will then be inserted over a guidewire and deployed across the stenosis. All stents will be fully covered SEMSs or partially covered SEMSs of 10 mm diameter. The length of the stent will be chosen at the discretion of the endoscopist performing the procedure. A prophylactic pancreatic stent will be placed in patients who will be thought to be at high risk of post-procedure pancreatitis at the discretion of the treating endoscopist. Receives: Procedure: pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of AE
such as the occurrence of unintentional perforation, bleeding requiring hemostasis, pancreatitis, stent malposition or migration, cholecystitis or cholangitis, jaundice, peritonitis, symptomatic bile leak, subcapsular liver hematoma, pneumoperitoneum, retained sheared wire, and procedure-related death
Measured: 0 to 3 months
Secondary outcomes (6)
Rate of any of the specific adverse events
such as the occurrence of unintentional perforation, bleeding requiring hemostasis, pancreatitis, stent malposition or migration, cholecystitis or cholangitis, jaundice, peritonitis, symptomatic bile leak, subcapsular liver hematoma, pneumoperitoneum, retained sheared wire, and procedure-related death
Measured: 0 to 3 months
Rate of technical success
Defined as the rate of successful stent placement in the desired duct at the initial procedure)
Measured: 0 to 3 months
Rate of clinical success
Defined as decrease of bilirubin level to either half the initial level, or less than 3 dl/mg -in order to allow to start chemotherapy
Measured: 0 to 3 months
Time needed for technical success
duration of a successful procedure
Measured: during procedure
Rate of reintervention
in the 3 months following the procedure, will evaluate the patients who need a reintervention
Measured: 0-3 months
Rate of cross-over
Defined as in case of failure of the procedure established by the randomization the rate of crossover to the other procedure done.
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Biliary 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
- Single group
- Masking
- None (open label)
- Enrolment
- 220 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
- NCT06550973
- Sponsor's protocol ID
- 4113
- Acronym
- PROMETHEUS
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicentric Trial, PROceeding With Advanced Techniques in Case of Distal Malignant Biliary Obstruction and Difficult Biliary Cannulation comparEd With Therapeutic-EUS: the PROMETHEUS Trial
- ClinicalTrials.gov ID
- NCT06550973
- Acronym / sponsor ID
- PROMETHEUS / 4113
- Conditions
- Malignant Biliary Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Aug 2024 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) stands as the primary approach for addressing jaundice in individuals with distal malignant biliary obstruction. A premise element in achieving success during therapeutic ERCP is selective biliary cannulation (SBC). Nevertheless, SBC doesn't consistently yield favorable outcomes, even among expert endoscopists, failing in around 25% to 50% of cases with standard ERCP approach (sphincterotome and guidewire).
In such situations, depending on the endoscopist's experience and preference, various advanced techniques come into play. These encompass the double guidewire cannulation approach, needle-knife precut papillotomy or fistulotomy, and transpancreatic sphincterotomy, serving as potential rescue methods.
In recent times, the EUS-guided approach has been gaining increasing significance. Initially, it was viewed as a rescue option in cases where advanced ERCP techniques failed (5-15% of cases). More recently, it has proved its feasibility as a first line alternative to ERCP in scenarios involving malignant biliary obstruction.
Detailed description
Rationale of the study Patients with distal malignant biliary obstruction have a higher risk of ERCP failure, related to the difficulty of bile duct cannulation. These patients after standard ERCP strategies failure, undergo advanced ERCP rescue strategies and in case of failure to EUS guided biliary drainage. HoweverEUS guided biliary drainage performed following the attempted advanced ERCP strategies, it may carry the risk of adverse events of advance ERCP strategies. We hypothesize that, in this setting of patients, early EUS guided biliary drainage in case of difficult biliary cannulation has a lower risk of post-procedural adverse events, as well as better overall safety and efficacy profiles. This could imply better outcomes such as for those patients who are planned to receive a chemotherapy before surgery in which a complication, such as acute pancreatitis, could delay the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-guided biliary drainage | No intervention | –EUS-guided biliary drainage will be performed using a bi-flanged lumen apposing metal stent (LAMS) mounted on an electrocautery-enhanced delivery. After EUS identification of the dilated CBD, a place without interposing vessels will be found by the endosonographer. Transduodenal puncture of the CBD will be performed directly with the LAMS that will be used to cautery the tract and enter the CBD. The diameter and length of the stent and the modality of placing the stent (under complete EUS view or with endoscopic or fluoroscopic guidance) will be chosen at the discretion of the endoscopist performing the procedure. |
| Rescue techniques | Experimental | Procedure: pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) techniqueRescue techniques, such as pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique, wire-guided cannulation over a pancreatic stent and transpancreatic biliary sphincterotomy, will be used at the discretion of the endoscopist [12]. After deep cannulation, a cholangiogram to better define the characteristics of the stenosis will be done. The stent will then be inserted over a guidewire and deployed across the stenosis. All stents will be fully covered SEMSs or partially covered SEMSs of 10 mm diameter. The length of the stent will be chosen at the discretion of the endoscopist performing the procedure. A prophylactic pancreatic stent will be placed in patients who will be thought to be at high risk of post-procedure pancreatitis at the discretion of the treating endoscopist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Patients with distal malignant biliary obstruction
- Abdominal ultrasound or computed tomography or magnetic resonance or EUS showing a dilated common bile duct > 15 mm diameter.
- Difficult biliary cannulation defined as ESGE guidelines
- Agree to receive follow up phone calls
Key exclusion criteria (5 listed)
- Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000 103/mm3.
- Use of anticoagulants that cannot be discontinued
- Pregnant women
- Previous ERCP or EUS-BD attempt
- Inability to sign the informed consent
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 |
|---|---|---|
| pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) techniqueRescue techniques, such as pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique, wire-guided cannulation over a pancreatic stent and transpancreatic biliary sphincterotomy, will be used at the discretion of the endoscopist [12]. After deep cannulation, a cholangiogram to better define the characteristics of the stenosis will be done. The stent will then be inserted over a guidewire and deployed across the stenosis. All stents will be fully covered SEMSs or partially covered SEMSs of 10 mm diameter. The length of the stent will be chosen at the discretion of the endoscopist performing the procedure. A prophylactic pancreatic stent will be placed in patients who will be thought to be at high risk of post-procedure pancreatitis at the discretion of the treating endoscopist. | Procedure or surgery | Rescue techniques |
Primary outcome
Rate of AE
Time frame: 0 to 3 months
such as the occurrence of unintentional perforation, bleeding requiring hemostasis, pancreatitis, stent malposition or migration, cholecystitis or cholangitis, jaundice, peritonitis, symptomatic bile leak, subcapsular liver hematoma, pneumoperitoneum, retained sheared wire, and procedure-related death
6 secondary outcomes
Rate of any of the specific adverse events
Time frame: 0 to 3 months
Rate of technical success
Time frame: 0 to 3 months
Rate of clinical success
Time frame: 0 to 3 months
Time needed for technical success
Time frame: during procedure
Rate of reintervention
Time frame: 0-3 months
Rate of cross-over
Time frame: 0-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing pre-cut biliary sphincterotomy/fistulotomy, double guide wire (DGW) technique in people with Malignant Biliary Obstruction, run by Istituto Clinico Humanitas.
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 6 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Alessandro Repici, Prof.,MD (0282247493, alessandro.repici@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of AE (time frame: 0 to 3 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 13 Aug 2024.