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

29. april 2015 opdateret af: Elham Afghani, Cedars-Sinai Medical Center

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Investigators will recruit patients presenting to Cedars-Sinai Medical Center for outpatient ERCP to be performed by one of the study investigators/treating physicians.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients receiving ERCP
Patients receiving Endoscopic retrograde cholangiopancreatography (ERCP) at Cedars-Sinai Medical Center.
ERCP's performed at Cedars-Sinai Medical Center.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intestinal Rate
Tidsramme: Participants will be followed for the duration of their hospital stay, an expected average of 4 days, and for 2 days after hospital discharge.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Elham Afghani, MD, Cedars-Sinai Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2015

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

23. april 2015

Først indsendt, der opfyldte QC-kriterier

29. april 2015

Først opslået (Skøn)

5. maj 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Pro00039663

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Pancreatitis

Kliniske forsøg med Endoscopic retrograde cholangiopancreatography (ERCP)

Abonner