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Post-ERCP Pancreatitis Severity Indication (PEPSI) Study (PEPSI)

14. december 2019 opdateret af: Georgios Papachristou, University of Pittsburgh
This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, the investigators hope to study markers of the early immune response to this injury and to develop a risk-assessment model.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Endoscopic Retrograde Cholangiopancreaticography (ERCP) is an important diagnostic and therapeutic tool in the management of pancreatic and biliary diseases. However, it carries up to 10% risk of developing acute pancreatitis, 10% of which will be severe. Current models to predict the severity of acute pancreatitis are incomplete and unable to prognosticate early in the course of the disease because they are based on biomarkers of late immune response. Recent findings suggest that polymorphisms in the gene coding for MCP-1 (Monocyte Chemotactic Protein-1) play an important role in the early immune response leading to either mild versus severe acute pancreatitis of various etiologies.

This study plans to directly address the problem of post-ERCP pancreatitis to gauge the various factors involved in its development and genetic variability in the immune response to an isolated pancreatic insult. In addition, we hope to study markers of the early immune response to this injury and to develop a risk-assessment model.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

48

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

14 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients 14 years of age and older, ERCP candidates.

Beskrivelse

Inclusion Criteria:

  1. All people presenting for ERCP procedures.
  2. Males and females of 14 years of age and older.
  3. Willingness to participate in the study and sign the informed consent. (Children will require a representative to sign the informed consent).
  4. People in whom therapeutic pancreatic interventions are planned during the ERCP procedure.
  5. Intact papilla

Exclusion Criteria:

  1. Persons unwilling to sign the informed consent
  2. Disorientation secondary to irreversible organic brain damage.
  3. Hemoglobin of less than 11 gm/dl in children of 10 years of age to puberty and hemoglobin of 12 gm/dl in pubertal males and females.
  4. Mean corpuscular volume (MCV) of less than 77 in all children of 18 years or younger.
  5. ERCP scheduled for stent change
  6. Previous diagnosis of pancreatic cancer or cholangiocarcinoma
  7. History of chronic pancreatitis
  8. Active Acute Pancreatitis prior to ERCP (typical pain and amylase or lipase >3 times UNL)or smoldering pancreatitis
  9. History of Recurrent Acute Pancreatitis with chronic pain between acute attacks of >5/10 more than 3 days per week.
  10. Previous sphincterotomy
  11. Post surgical anatomy
  12. History of organ transplant
  13. On medications for the treatment of HIV

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
ERCP candidates

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients who develop post ERCP pancreatitis as assessed by their clinical course
Tidsramme: 1 year
Develop a multi-factorial mathematical risk model that will help predict the exact risk for pancreatitis-associated complications of ERCP and to help power and structure future interventional studies.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients with high serum amylase and cytokine levels as assessed by their clinical data.
Tidsramme: 1 year
Determine the relationship between pre and post-ERCP serum amylase and cytokine levels including IL-6, IL-8, CRP and MCP-1 and other injury or inflammatory markers as biomarkers of genetic polymorphisms in the corresponding genes.
1 year
Genetic markers that cause patients to develop post ERCP pancreatitis as identified by their genes
Tidsramme: 1 year
Determine if genetic polymorphisms of Monocyte Chemotactic Protein-1 (MCP-1) confer an increased risk for post-ERCP (Endoscopic Retrograde Cholangio- Pancreaticography) acute pancreatitis.
1 year

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studiestol: Georgios I Papachristou, MD, Ohio State University

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 (Faktiske)

22. april 2009

Primær færdiggørelse (Faktiske)

22. november 2019

Studieafslutning (Faktiske)

22. november 2019

Datoer for studieregistrering

Først indsendt

2. februar 2017

Først indsendt, der opfyldte QC-kriterier

8. marts 2017

Først opslået (Faktiske)

9. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. december 2019

Sidst verificeret

1. december 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB0609028

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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

3
Abonner