NCT02433444

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Status
unknown

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

April 23, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 5, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

April 23, 2015

Last Update Submit

April 29, 2015

Conditions

Pancreatitis

Keywords

Biosensing Techniques

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Patients receiving ERCP

Patients receiving Endoscopic retrograde cholangiopancreatography (ERCP) at Cedars-Sinai Medical Center.

Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)

Interventions

Endoscopic retrograde cholangiopancreatography (ERCP)PROCEDURE

ERCP's performed at Cedars-Sinai Medical Center.

Patients receiving ERCP

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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. doi: 10.1067/mge.2001.117550.

    PMID: 11577302BACKGROUND

  • 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.

    PMID: 14518287BACKGROUND

  • 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.

    PMID: 21353066BACKGROUND

  • Shambroom JR, Fabregas 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.

    PMID: 21859438BACKGROUND

  • 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.

    PMID: 25091837BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatic 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 Procedures

Study Officials

  • Elham Afghani, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elham Afghani, MD

CONTACT

310-423-5462Elham.Afghani@cshs.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director,Clinical Pancreatology

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 5, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 5, 2015

Record last verified: 2015-04