NCT03775681

Brief 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. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 16, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

April 27, 2021

Completed
Last Updated

April 27, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

December 12, 2018

Results QC Date

January 13, 2021

Last Update Submit

March 31, 2021

Conditions

Bile Duct DisorderEndocrine Pancreas Disorder

Outcome Measures

Primary Outcomes (1)

  • The Number of Participants With Overall Success of ERCP With LMA Gastro

    Successful completion of ERCP with the LMA® Gastro™

    Up to 3 months

Other Outcomes (1)

  • Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™

    Up to 3 months

Study Arms (1)

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.

Procedure: Endoscopic Retrograde CholangiopancreatographyOther: InterviewDevice: Laryngeal Mask Airway

Interventions

Endoscopic Retrograde CholangiopancreatographyPROCEDURE

Undergo standard of care ERCP

Also known as: ERCP
Device feasibility (Laryngeal Mask Airway, ERCP)
InterviewOTHER

Ancillary studies

Device feasibility (Laryngeal Mask Airway, ERCP)
Laryngeal Mask AirwayDEVICE

Wear LMA

Also known as: Laryngeal Mask; LMA
Device feasibility (Laryngeal Mask Airway, ERCP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients undergoing elective ERCP with general anesthesia

You may not qualify if:

  • 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
  • Patients undergoing endoscopic ultrasound (EUS)
  • Patients with body mass index (BMI) 35 kg/m\^2
  • Non-English speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 33079880DERIVED

Related Links

MeSH Terms

Conditions

Bile Duct Diseases

Interventions

Cholangiopancreatography, Endoscopic RetrogradeInterviews as TopicLaryngeal Masks

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthIntubation, IntratrachealAirway ManagementTherapeuticsIntubationMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Katherine Hagan, Associate Professor, Anesthesiology & PeriOper Med
Organization
UT MD Anderson Cancer Center
khagan@mdanderson.org
(713) 794-5945

Study Officials

  • Katherine Hagan

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 14, 2018

Study Start

January 16, 2019

Primary Completion

April 20, 2020

Study Completion

April 20, 2020

Last Updated

April 27, 2021

Results First Posted

April 27, 2021

Record last verified: 2021-03

Locations

US(1)