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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-03163 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0545 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography | Procedure | Undergo standard of care ERCP |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Overall Success of ERCP With LMA Gastro | Successful completion of ERCP with the LMA® Gastro™ | Up to 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™ | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Hagan | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33079880 | Derived | 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. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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Recruitment Period: January 2019 to July 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | LMA® Gastro™ | Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2019 |
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| Interview | Other | Ancillary studies |
|
| Laryngeal Mask Airway | Device | Wear LMA |
|
|
| Up to 3 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Race and Ethnicity was not the criteria for Inclusion in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | LMA® Gastro™ | Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) | Type of ERCP cases involving the use of LMA Gastro | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Overall Success of ERCP With LMA Gastro | Successful completion of ERCP with the LMA® Gastro™ | Posted | Count of Participants | Participants | Up to 3 months |
|
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| |||||||||||||||||||||||||||
| Other Pre-specified | Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™ | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 3 months |
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Baseline
This is a non-randomized, unblinded feasibility study involving use of LMA Gastro device for ERCP. The device has been deemed low risk and there are no additional risk to the patient. No AE/SAE's to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LMA® Gastro™ | Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Hagan, Associate Professor, Anesthesiology & PeriOper Med | UT MD Anderson Cancer Center | (713) 794-5945 | khagan@mdanderson.org |
| Oct 13, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| D007407 | Interviews as Topic |
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Unknown or Not Reported |
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| Stent Exchange |
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| Diagnostic |
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| Other |
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