Biliary ObstructionSPAXUSNCT04723199
Feasibility of EUS-guided Biliary Drainage With LAMS for the Treatmentof Patients With Distal Malignant Biliary Obstruction
An observational study of Biliary Obstruction, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Distal malignant biliary obstruction results from different types of tumors including pancreatic cancer, biliary tract cancer (BTC), gallbladder cancer, and metastasis, which can lead to obstructive jaundice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction
- What is being tested?
- Electrocautetery LAMS
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2020to 31 Dec 2021
- Phase
- Observational
- 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
Study population: This is an observational multicentric prospective study coordinated by Dr. Benedetto Mangiavillano, Gastroenterology and Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza (VA), Italy. Data from consecutive patients with jaundice caused by distal malignant biliary obstruction will be evaluated and, if eligible and agreed to participate, will be recorded in an electronic register. Patients will be followed until death or for at least 6 months
Who may be able to join
- Age ≥18 years
- Patients with distal malignant biliary obstruction
- Dilated common bile duct (>15 mm diameter) at either abdominal ultrasound, computed tomography, magnetic resonance or EUS or accessible gallbladder from the duodenum or from the stomach for the drainage
- 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
- Use of anticoagulants that cannot be discontinued
- Pregnant women
- Inability to sign the informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Mater Domini
Castellanza, 21053
Benedetto Mangiavillano, MD, (+39) 0331 476205 - 381, benedetto.mangiavillano@mc.humanitas.it
About this study
Official title: Feasibility of EUS-guided Biliary Drainage With a New-type of Eletrocautery LAMS for the Treatmentof Patients With Distal Malignant Biliary Obstruction (SPAZUS)
Distal malignant biliary obstruction results from different types of tumors including pancreatic cancer, biliary tract cancer (BTC), gallbladder cancer, and metastasis, which can lead to obstructive jaundice. Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in this setting of patients. However, surgically altered anatomy (i.e., Whipple intervention, Roux-en-Y gastric bypass, Billroth II surgery), periampullary diverticula, gastric outlet obstruction, and malignant obstruction of the lumen determine the failure of the procedure in about 5-10% of cases, requiring alternative methods of decompression. Percutaneous transhepatic biliary drainage (PTBD) and surgical bypass are well established alternatives in these patients, but associated with increased morbidity, longer length of hospital stay and higher costs, and patient discomfort.
In 2001 Giovannini et al. described the first EUS guided biliary drainage (EUS-BD) through a transduodenal access with a needle knife.
Read more
Subsequently, EUS-BD has considerably evolved thanks to the development of dedicated devices such as lumen apposing metal stents (LAMS), specifically designed for endoscopic ultrasound procedures. LAMS are made up of braided nitinol, that is fully covered with silicone to prevent tissue ingrowth, with wide flanges on both ends to provide anchorage.
Recently, LAMS have been incorporated into a delivery system with an electrocautery mounted on the tip (Hot Axios; Boston Scientific Corp.), which allows the device to be used directly to penetrate the target structure without the need to utilize a 19G needle, a guidewire, and a cystotome for prior dilation. This has been described for drainage of peri-pancreatic fluid collections, common bile duct (CBD), gallbladder, and for creation of gastro-jejuno anastomosis. The biliary drainage procedure performed with the Hot Axios sistem is a one step procedure that requires less or no need for accessory exchange and becomes faster, thus potentially decreasing the risk of complications.
The procedure has been described as safe and effective with a technical success of 98.2 %, clinical success of 96.4 %, and low rate of complications 7 % (duodenal perforations, bleeding and transient cholangitis). A systematic review and meta-analyses showed clinical and technical success rates of 87% and 95% respectively. Currently, the EUS-BD is indicated as a rescue therapy for jaundice palliation after ERCP failure.
- Conditions
- Biliary Obstruction
- Being tested
- Electrocautetery LAMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocautetery LAMSDevice
Electrocautetery LAMS
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of technical success
The rate of successful LAMS placement in the targeted organ
Measured: 12 Months
Rate of clinical success
Decrease of the total bilirubin levels > 20% at 24 hours after procedure
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start16 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
- NCT04723199
- Sponsor's protocol ID
- 102
- Acronym
- SPAXUS
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 26 Jan 2021
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of EUS-guided Biliary Drainage With a New-type of Eletrocautery LAMS for the Treatmentof Patients With Distal Malignant Biliary Obstruction (SPAZUS)
- ClinicalTrials.gov ID
- NCT04723199
- Acronym / sponsor ID
- SPAXUS / 102
- Conditions
- Biliary Obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Jan 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.
Distal malignant biliary obstruction results from different types of tumors including pancreatic cancer, biliary tract cancer (BTC), gallbladder cancer, and metastasis, which can lead to obstructive jaundice. Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in this setting of patients. However, surgically altered anatomy (i.e., Whipple intervention, Roux-en-Y gastric bypass, Billroth II surgery), periampullary diverticula, gastric outlet obstruction, and malignant obstruction of the lumen determine the failure of the procedure in about 5-10% of cases, requiring alternative methods of decompression. Percutaneous transhepatic biliary drainage (PTBD) and surgical bypass are well established alternatives in these patients, but associated with increased morbidity, longer length of hospital stay and higher costs, and patient discomfort.
In 2001 Giovannini et al. described the first EUS guided biliary drainage (EUS-BD) through a transduodenal access with a needle knife.
Subsequently, EUS-BD has considerably evolved thanks to the development of dedicated devices such as lumen apposing metal stents (LAMS), specifically designed for endoscopic ultrasound procedures. LAMS are made up of braided nitinol, that is fully covered with silicone to prevent tissue ingrowth, with wide flanges on both ends to provide anchorage.
Recently, LAMS have been incorporated into a delivery system with an electrocautery mounted on the tip (Hot Axios; Boston Scientific Corp.), which allows the device to be used directly to penetrate the target structure without the need to utilize a 19G needle, a guidewire, and a cystotome for prior dilation. This has been described for drainage of peri-pancreatic fluid collections, common bile duct (CBD), gallbladder, and for creation of gastro-jejuno anastomosis. The biliary drainage procedure performed with the Hot Axios sistem is a one step procedure that requires less or no need for accessory exchange and becomes faster, thus potentially decreasing the risk of complications.
The procedure has been described as safe and effective with a technical success of 98.2 %, clinical success of 96.4 %, and low rate of complications 7 % (duodenal perforations, bleeding and transient cholangitis). A systematic review and meta-analyses showed clinical and technical success rates of 87% and 95% respectively. Currently, the EUS-BD is indicated as a rescue therapy for jaundice palliation after ERCP failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational multicentric prospective study coordinated by Dr. Benedetto Mangiavillano, Gastroenterology and Gastrointestinal Endoscopy Unit, Humanitas Mater Domini, Castellanza (VA), Italy. Data from consecutive patients with jaundice caused by distal malignant biliary obstruction will be evaluated and, if eligible and agreed to participate, will be recorded in an electronic register. Patients will be followed until death or for at least 6 months
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patients with distal malignant biliary obstruction
- Dilated common bile duct (>15 mm diameter) at either abdominal ultrasound, computed tomography, magnetic resonance or EUS or accessible gallbladder from the duodenum or from the stomach for the drainage
- Agree to receive follow up phone calls
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000
- Use of anticoagulants that cannot be discontinued
- Pregnant women
- 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 |
|---|---|---|
| Electrocautetery LAMSElectrocautetery LAMS | Device | – |
Primary outcome
Rate of technical success
Time frame: 12 Months
The rate of successful LAMS placement in the targeted organ
Rate of clinical success
Time frame: 12 Months
Decrease of the total bilirubin levels > 20% at 24 hours after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- 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?
An observational study of Biliary 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 5 inclusion and 4 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 26 Jan 2021. 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 Benedetto Mangiavillano, MD ((+39) 0331 476205 - 381, benedetto.mangiavillano@mc.humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of technical success (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 26 Jan 2021.