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Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders

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ClinicalTrials.gov Identifier: NCT03775681
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Bile Duct Disorder Endocrine Pancreas Disorder Procedure: Endoscopic Retrograde Cholangiopancreatography Other: Interview Device: Laryngeal Mask Airway Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the successful completion of endoscopic retrograde cholangiopancreatography (ERCP) with the Laryngeal Mask Airway (LMA) Gastro.

SECONDARY OBJECTIVES:

I. 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.

V. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Is the Gastro LMA a Feasible Alternative to the Use of a Native Airway for Endoscopic Retrograde Cholangiopancreatography (ERCP) Cases?
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: Device feasibility (Laryngeal Mask Airway, ERCP)
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 Cholangiopancreatography
Undergo standard of care ERCP
Other Name: ERCP

Other: Interview
Ancillary studies

Device: Laryngeal Mask Airway
Wear LMA
Other Name: Laryngeal Mask; LMA




Primary Outcome Measures :
  1. Success rate [ Time Frame: Up to 3 months ]
    The success rate will be estimated using an exact 95% confidence interval. Descriptive statistics will be used to summarize all study data. Frequencies and percentages will be used to summarize the failure and success rates. Interval estimation of rates will be provided using Clopper-Pearson exact 95% confidence intervals (CIs).


Secondary Outcome Measures :
  1. Gastroenterologist satisfaction [ Time Frame: Up to 3 months ]
    Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.

  2. Anesthesia provider satisfaction [ Time Frame: Up to 3 months ]
    Surveys for gastroenterologist and anesthesiologist satisfaction with the LMA Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients undergoing elective ERCP with general anesthesia

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775681


Contacts
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Contact: Katherine Hagan 713-563-0034 khagan@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Katherine Hagan    713-563-0034      
Principal Investigator: Katherine Hagan         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Katherine Hagan M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03775681     History of Changes
Other Study ID Numbers: 2018-0545
NCI-2018-03163 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0545 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Disease
Bile Duct Diseases
Pancreatic Diseases
Pathologic Processes
Biliary Tract Diseases
Digestive System Diseases