Bile Duct DisorderNCT03775681
Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders
A study testing Endoscopic Retrograde Cholangiopancreatography, Interview and Laryngeal Mask Airway in people with Bile Duct Disorder and Endocrine Pancreas Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Disorder, Endocrine Pancreas Disorder
- What is being tested?
- Endoscopic Retrograde Cholangiopancreatography, Interview and Laryngeal Mask Airway
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 20 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients undergoing elective ERCP with general anesthesia
Who cannot join
- Patients with propofol allergy
- Patients at increased aspiration risk
- Patients with abnormal head/neck pathology preventing LMA Gastro placement
- Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
- Esophagectomy patients
- Patients already intubated upon arrival to endoscopy suite
Show all 9Show fewer
- Patients undergoing endoscopic ultrasound (EUS)
- Patients with body mass index (BMI) 35 kg/m^2
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?
This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the successful completion of endoscopic retrograde cholangiopancreatography (ERCP) with the Laryngeal Mask Airway (LMA) Gastro.
SECONDARY OBJECTIVES:
- To determine gastroenterologist satisfaction with the LMA Gastro.
II. To determine anesthesia provider satisfaction with the LMA Gastro.
III. To determine the rate of unsuccessful LMA Gastro placement.
IV. To determine the ability of LMA Gastro to provide adequate oxygenation and ventilation throughout the procedure.
- To determine and describe the rate of adverse events.
OUTLINE:
Patients wear Laryngeal Mask Airway Gastro after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.
- Conditions
- Bile Duct Disorder, Endocrine Pancreas Disorder
- Being tested
- Endoscopic Retrograde Cholangiopancreatography, Interview, Laryngeal Mask Airway
- Medical subject headings
- Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde CholangiopancreatographyProcedure or surgery
Also called ERCP
Undergo standard of care ERCP
InterviewOther
Ancillary studies
Laryngeal Mask AirwayDevice
Also called Laryngeal Mask; LMA
Wear LMA
| Study group | Role | What they receive |
|---|---|---|
| Device feasibility (Laryngeal Mask Airway, ERCP) | Experimental | Patients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure. Receives: Procedure: Endoscopic Retrograde Cholangiopancreatography; Other: Interview; Device: Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Overall Success of ERCP With LMA Gastro
Successful completion of ERCP with the LMA® Gastro™
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start16 Jan 2019
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katherine Hagan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775681
- Sponsor's protocol ID
- 2018-0545
- Other IDs
- NCI-2018-03163, 2018-0545
- Status last verified
- Mar 2021
- First submitted
- 12 Dec 2018
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hagan KB, Carlson R, Arnold B, Nguyen L, Lee J, Weston B, Hernandez M, Feng L, Syed T, Hagberg CA. Safety of the LMA(R)Gastro for Endoscopic Retrograde Cholangiopancreatography. Anesth Analg. 2020 Nov;131(5):1566-1572. doi: 10.1213/ANE.0000000000005183.
PubMed 33079880
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?
- ClinicalTrials.gov ID
- NCT03775681
- Acronym / sponsor ID
- 2018-0545
- Conditions
- Bile Duct Disorder, Endocrine Pancreas Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.
Detailed description
PRIMARY OBJECTIVES:
- To determine the successful completion of endoscopic retrograde cholangiopancreatography (ERCP) with the Laryngeal Mask Airway (LMA) Gastro.
SECONDARY OBJECTIVES:
- To determine gastroenterologist satisfaction with the LMA Gastro.
II. To determine anesthesia provider satisfaction with the LMA Gastro.
III. To determine the rate of unsuccessful LMA Gastro placement.
IV. To determine the ability of LMA Gastro to provide adequate oxygenation and ventilation throughout the procedure.
- To determine and describe the rate of adverse events.
OUTLINE:
Patients wear Laryngeal Mask Airway Gastro after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (Laryngeal Mask Airway, ERCP) | Experimental | Procedure: Endoscopic Retrograde Cholangiopancreatography, Other: Interview, Device: Laryngeal Mask AirwayPatients wear Laryngeal Mask Airway after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing elective ERCP with general anesthesia
Key exclusion criteria (9 listed)
- Patients with propofol allergy
- Patients at increased aspiration risk
- Patients with abnormal head/neck pathology preventing LMA Gastro placement
- Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
- Esophagectomy patients
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 Retrograde CholangiopancreatographyAlso: ERCPUndergo standard of care ERCP | Procedure or surgery | Device feasibility (Laryngeal Mask Airway, ERCP) |
| InterviewAncillary studies | Other | Device feasibility (Laryngeal Mask Airway, ERCP) |
| Laryngeal Mask AirwayAlso: Laryngeal Mask; LMAWear LMA | Device | Device feasibility (Laryngeal Mask Airway, ERCP) |
Primary outcome
The Number of Participants With Overall Success of ERCP With LMA Gastro
Time frame: Up to 3 months
Successful completion of ERCP with the LMA® Gastro™
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33079880Hagan KB, Carlson R, Arnold B, Nguyen L, Lee J, Weston B, Hernandez M, Feng L, Syed T, Hagberg CA. Safety of the LMA(R)Gastro for Endoscopic Retrograde Cholangiopancreatography. Anesth Analg. 2020 Nov;131(5):1566-1572. doi: 10.1213/ANE.0000000000005183.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Katherine Hagan principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Retrograde Cholangiopancreatography, Interview and Laryngeal Mask Airway in people with Bile Duct Disorder and Endocrine Pancreas Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
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 9 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 27 Apr 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants With Overall Success of ERCP With LMA Gastro (time frame: Up to 3 months). 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 NCT03775681, which also lists 1 linked publication.
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 27 Apr 2021.