Pancreatic CancerLAMSpigBilNCT04420039
Plastic Stent Within a Lumen-Apposing Stent for Malignant Biliary Obstruction
An observational study of Pancreatic Cancer and Endoscopy, run by Hospital Universitari de Bellvitge at 3 sites in Spain.
Trial summary
There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Endoscopy, Oncologic Disorders
- What is being tested?
- Endoscopic biliary transmural drainage
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 3 sitesSpain
- Study dates
- May 2015to Mar 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
- Adult, Older adult
Study population: Palliative malignant biliopancreatic pathology
Who may be able to join
- Consecutive unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla
Who cannot join
- Borderline cancer cases
- Others type of biliary stents
- Severe coagulopathy or thrombocytopenia.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, 08041
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, 08221
About this study
Official title: Is Useful a Coaxial Plastic Stent Within a Lumen-Apposing Metal Stent For The Palliative Management Of Malignant Biliary Obstruction?
There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.
- Being tested
- Endoscopic biliary transmural drainage
- Keywords
- Malignant biliary obstrucction, Therapeutic endoscopy, Biliary drainage, Lumen apposing stent, Endoscopic Ultrasound, Pancreatic neoplasm
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic biliary transmural drainageDevice
Also called Endoscopic Ultrasound-guided biliary drainage, Choledochoduodenostomy
Endosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction.
Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent.
| Study group | Role | What they receive |
|---|---|---|
| 1- Single biliary LAMS | Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent after failed ERCP cannulation or inaccessible papilla. Receives: Device: Endoscopic biliary transmural drainage | |
| 2- Biliary LAMS plus Doublu-Pigtail plastic Etent | Unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent (plus double-pigtail plastic stent) after failed ERCP cannulation or inaccessible papilla. Receives: Device: Endoscopic biliary transmural drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential benefits
to respond if a coaxial DPS within a biliary LAMS really has a potential benefit in the EUS-BD (less number of adverse events: cholangitis, bleeding, sump syndrome, cholestasis secondary to stent biliary obstruction)
Measured: 4 weeks
Secondary outcomes (4)
Technical success
Technical success was defined as a successful stent placement between the extrahepatic bile duct and duodenal lumen in a single step approach and determined by endoscopy and fluoroscopy
Measured: 24 hours
Clinical success
Clinical success was defined as a reduction in bilirubin by 50% at 2-weeks after stent placement, meaning that the biliary stent was functional.
Measured: 4 weeks
Procedure time
Procedure time was defined from the insertion of the endoscope to its removal.
Measured: 2 hours
Biliary reintervention
Biliary reintervention: the need to perform additional interventions to achieve biliary drainage.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study startMay 2015
- Primary completionSep 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Principal investigator, Joan B Gornals, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420039
- Sponsor's protocol ID
- HUBellvitge
- Acronym
- LAMSpigBil
- Status last verified
- Jul 2021
- First submitted
- 1 Jun 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Useful a Coaxial Plastic Stent Within a Lumen-Apposing Metal Stent For The Palliative Management Of Malignant Biliary Obstruction?
- ClinicalTrials.gov ID
- NCT04420039
- Acronym / sponsor ID
- LAMSpigBil / HUBellvitge
- Keywords
- Malignant biliary obstrucction, Therapeutic endoscopy, Biliary drainage, Lumen apposing stent, Endoscopic Ultrasound, Pancreatic neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Hospital Mutua de Terrassa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Institut d'Investigació Biomèdica de Bellvitge
- Study start
- May 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 9 Jun 2020 (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.
There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided transmural biliary drainage (BD). The aims was to evaluate the safety of LAMS with and without a coaxial DPS in EUS-BD for the palliative management in malignant biliary obstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- Single biliary LAMS | – | Device: Endoscopic biliary transmural drainageUnresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent after failed ERCP cannulation or inaccessible papilla. |
| 2- Biliary LAMS plus Doublu-Pigtail plastic Etent | – | Device: Endoscopic biliary transmural drainageUnresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD with a single lumen-apposing stent (plus double-pigtail plastic stent) after failed ERCP cannulation or inaccessible papilla. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Palliative malignant biliopancreatic pathology
Key inclusion criteria (1 listed)
- Consecutive unresectable/inoperable biliopancreatic cases with distal biliary obstruction who underwent EUS-BD after failed ERCP cannulation or inaccessible papilla
Key exclusion criteria (3 listed)
- Borderline cancer cases
- Others type of biliary stents
- Severe coagulopathy or thrombocytopenia.
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 |
|---|---|---|
| Endoscopic biliary transmural drainageAlso: Endoscopic Ultrasound-guided biliary drainage, CholedochoduodenostomyEndosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction. Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent. | Device | 1- Single biliary LAMS, 2- Biliary LAMS plus Doublu-Pigtail plastic Etent |
Primary outcome
Potential benefits
Time frame: 4 weeks
to respond if a coaxial DPS within a biliary LAMS really has a potential benefit in the EUS-BD (less number of adverse events: cholangitis, bleeding, sump syndrome, cholestasis secondary to stent biliary obstruction)
4 secondary outcomes
Technical success
Time frame: 24 hours
Clinical success
Time frame: 4 weeks
Procedure time
Time frame: 2 hours
Biliary reintervention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Endoscopy, run by Hospital Universitari de Bellvitge at 3 sites in Spain.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential benefits (time frame: 4 weeks). 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 Jul 2021.