Pancreatic CollectionNCT03282539
Lumen Apposing Metal Stents With and Without a Double Pigtail Stent in Pancreatic Collections
An observational study of Pancreatic Collection, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic stent in the management of pancreatic fuid collections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Collection
- What is being tested?
- LAMS and LAMS + pigtail
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- May 2011to Feb 2017
- 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: Patients wiht pancreatic fluid collections and indication for EUS-guided transmural drainage in accordance l wiht international creteria.
Who may be able to join
- Patients with pancreatic fluid collections and indication of drainage.
- EUS-guided trasmural drainage wiht lumen apposing metal stents.
- Criteria for drainage were as specified by the Working Group of the International Association of Pancreatology.
Who cannot join
- Other types of collections and stents
- Severe coagulopathy (protombin time > 1,5) or thrombocytopenia (platelet count < 50 x 109/L)
- PFCs with a previous attempt failed of EUS-guided transmural drainage
- Age younger than 18 years
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Lumen Apposing Metal Stents With and Without a Coaxial Double Pigtail Stent in the Management of Pancreatic Fluid Collections
The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic stent in the management of pancreatic fuid collections.
Read the detailed description
The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer than other types of stents due to the presence of bilateral anchoring flanges, designed to appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC, specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS syndrome have also been related . The placement of a coaxial double pigtail plastic within the LAMS has been reported beneficial in order to avoid external migration or the lumen obstruction and to the prevention of bleeding and other adverse events. The aim of this study was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail plastic stent in the EUS-guided transmural drainage of PFCs.
- Conditions
- Pancreatic Collection
- Being tested
- LAMS, LAMS + pigtail
- Keywords
- Lumen apposing metal stents, Double pigtail stents, Endoscopic ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAMSDevice
EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents
LAMS + pigtailDevice
EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent
| Study group | Role | What they receive |
|---|---|---|
| LAMS | EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents. Receives: Device: LAMS | |
| LAMS + pigtail | EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent Receives: Device: LAMS + pigtail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Defined and graded according to the ASGE lexicon's severity grading system
Measured: Outcomes will be assessed 6 months after the inclusion of last patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study startMay 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CollectionStudies 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOAN B GORNALS, Hospital Universitari de Bellvitge
- Investigators
- Joan Gornals, Principal investigator, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282539
- Sponsor's protocol ID
- LAMSpig1
- Status last verified
- Aug 2017
- First submitted
- 8 Aug 2017
- Last updated
- 14 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The results of the stuydy will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumen Apposing Metal Stents With and Without a Coaxial Double Pigtail Stent in the Management of Pancreatic Fluid Collections
- ClinicalTrials.gov ID
- NCT03282539
- Acronym / sponsor ID
- LAMSpig1
- Conditions
- Pancreatic Collection
- Keywords
- Lumen apposing metal stents, Double pigtail stents, Endoscopic ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- May 2011 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 14 Sep 2017 (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.
The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic stent in the management of pancreatic fuid collections.
Detailed description
The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer than other types of stents due to the presence of bilateral anchoring flanges, designed to appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC, specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS syndrome have also been related . The placement of a coaxial double pigtail plastic within the LAMS has been reported beneficial in order to avoid external migration or the lumen obstruction and to the prevention of bleeding and other adverse events. The aim of this study was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail plastic stent in the EUS-guided transmural drainage of PFCs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAMS | – | Device: LAMSEUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents. |
| LAMS + pigtail | – | Device: LAMS + pigtailEUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients wiht pancreatic fluid collections and indication for EUS-guided transmural drainage in accordance l wiht international creteria.
Key inclusion criteria (3 listed)
- Patients with pancreatic fluid collections and indication of drainage.
- EUS-guided trasmural drainage wiht lumen apposing metal stents.
- Criteria for drainage were as specified by the Working Group of the International Association of Pancreatology.
Key exclusion criteria (4 listed)
- Other types of collections and stents
- Severe coagulopathy (protombin time > 1,5) or thrombocytopenia (platelet count < 50 x 109/L)
- PFCs with a previous attempt failed of EUS-guided transmural drainage
- Age younger than 18 years
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 |
|---|---|---|
| LAMSEUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents | Device | LAMS |
| LAMS + pigtailEUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent | Device | LAMS + pigtail |
Primary outcome
Adverse events
Time frame: Outcomes will be assessed 6 months after the inclusion of last patient.
Defined and graded according to the ASGE lexicon's severity grading system
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 14 Sep 2017.
- Individual participant dataSharing planned: No. The results of the stuydy will be shared with other researchers.
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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.
Joan Gornals principal investigator
Hospital Universitari de Bellvitge
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 Pancreatic Collection, run by Hospital Universitari de Bellvitge at 1 site 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 3 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: finished, as of the sponsor's last update on 14 Sep 2017. 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 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?
Adverse events (time frame: Outcomes will be assessed 6 months after the inclusion of last patient.). 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 14 Sep 2017.