Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance in Post-ERCP Pancreatitis

Pancreatitis Clinical Trial

Official title:

Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Post-ERCP Pancreatitis (PEP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02433444
• Other study ID #: Pro00039663
• Status: Not yet recruiting
• Phase: N/A
• First received: April 23, 2015
• Last updated: April 29, 2015
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Cedars-Sinai Medical Center
• Contact: Elham Afghani, MD
• Phone: 310-423-5462
• Email: Elham.Afghani[@]cshs.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatitis

Intervention

Procedure:
• Endoscopic retrograde cholangiopancreatography (ERCP)
ERCP's performed at Cedars-Sinai Medical Center.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	University of California, Los Angeles

References & Publications (5)

Augustyniak P. Wearable wireless heart rate monitor for continuous long-term variability studies. J Electrocardiol. 2011 Mar-Apr;44(2):195-200. doi: 10.1016/j.jelectrocard.2010.11.014. — View Citation

Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. — View Citation

Rieger H, Runkel N, Spröder 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. — View Citation

Shambroom JR, Fábregas SE, Johnstone J. Validation of an automated wireless system to monitor sleep in healthy adults. J Sleep Res. 2012 Apr;21(2):221-30. doi: 10.1111/j.1365-2869.2011.00944.x. Epub 2011 Aug 22. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Rate	Count of motility events (as measured by AGIS) per minute	Participants will be followed for the duration of their hospital stay, an expected average of 4 days, and for 2 days after hospital discharge.	No