Clinical trial NCT02433444: Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance in Post-ERCP Pancreatitis
Official title: Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Post-ERCP Pancreatitis (PEP)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatitis
Keywords: Biosensing Techniques
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2015-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will recruit patients presenting to Cedars-Sinai Medical Center for outpatient ERCP to be performed by one of the study investigators/treating physicians.

Brief summary: In this study, the investigators aim to distinguish patients with Post-Endoscopic retrograde cholangiopancreatography (ERCP) Pancreatitis (PEP) vs. those without PEP based on difference in pre- vs. post-ERCP measurements of AGIS-derived intestinal rates (IR). Based on the clinical observation that many patients with PEP develop ileus following ERCP, the investigators hypothesize that patients who develop PEP will exhibit lower IR following ERCP, and therefore a larger difference in pre- vs. post-ERCP IR.

Detailed description: This will be a prospective case series in 100 patients presenting to Cedars Sinai Medical Center who undergo Endoscopic retrograde cholangiopancreatography (ERCP).

The investigators will place the AGIS sensor on each patient enrolled in the study, 30 minutes prior to procedure. The investigators will continuously record AGIS acoustic signals from T-30 minutes to the time that they leave the hospital, either on discharge from the Post-Anesthesia Care Unit or discharge from hospitalization, with the option to discontinue if clinically required or requested by the provider or patient. Acoustic signal will be evaluated, and intestinal motility events will be calculated; however, this data will not be used to make decisions regarding clinical care. Physicians and nurses will not be made aware of the AbStats readings.These measurements are solely observational. Patients will be managed according to standard-of-care practice.

Routinely, patients are kept in the post-operative unit after their procedure, for one hour. Those with pain are examined by a physician and the decision is made to admit for observation to monitor for complications of ERCP, or to discharge home. The patients who are discharged home from procedure will be followed by telephone surveys every day for 2 days post procedure to determine if they have developed symptoms suggestive of PEP. If so, they will be asked to go to the closest urgent care or emergency department for further evaluation. Those who are admitted for observations post procedure will be followed for signs or symptoms of PEP which includes meeting 2 of 3 criteria: Abdominal pain, amylase/lipase \>3 times the upper limit of normal 24 hours after procedure, and/or imaging consistent with pancreatitis.

The AGIS multi-sensor wireless abdominal monitoring system includes low profile acoustic sensors that are applied to the anterior abdominal wall with Tegaderm and monitors sounds emanating from the GI tract. The acoustic sensors continuously and non-invasively monitor and capture audio signals representing GI and abdominal wall function. The captured data is recorded in a synchronized manner from two sensors, each placed 3cm on either side of the umbilicus.

After a patient's participation in the study is complete, the investigators will analyze the AbStats readings and the their clinical outcomes to observe if correlations exist between patients with lower intestinal rates and those who develop PEP.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Patient of Cedars-Sinai Medical Center scheduled for outpatient ERCP to be performed by one of the study investigators/treating physicians
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide consent
* Transfer patients
* Cognitive inability to follow directions to maintain sensors in place
* Unable to place abdominal sensors on patients
* Abdominal cellulitis
* Pregnant women

Primary outcomes:
measure: Intestinal Rate
timeFrame: Participants will be followed for the duration of their hospital stay, an expected average of 4 days, and for 2 days after hospital discharge.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Elham Afghani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rieger H, Runkel N, Sproder J, Buhr HJ. [Different mechanisms in intestinal paralysis in edematous and necrotizing pancreatitis of the rat]. Langenbecks Arch Chir Suppl Kongressbd. 1998;115(Suppl I):409-12. German.
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citation: Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.