- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02042859
Radiofrequency Probe for Management of Unresectable Bile Duct and Pancreatic Cancer (EndoHPB)
20. januar 2014 opdateret af: Virendra Joshi, Ochsner Health System
Pilot Study to Assess Safety and Efficacy Of An Endoscopic Bipolar Radiofrequency Probe (EndoHPB) In the Management of Unresectable Bile Duct and Pancreatic Cancer
The purpose of this study is to determine whether the use of an FDA approved endoscopic bipolar catheter (EndoHPB) will ablate tissue in malignant tumors within the pancreatic ducts.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret beskrivelse
Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection.
Therefore most patients with malignant biliary obstruction will need palliation of their jaundice to relieve the symptoms of pruritus, malabsorption, sepsis and to minimize potential hepatorenal complications.
Restoring biliary flow with relief of jaundice is the primary goal in the palliation of obstructive biliary malignancy.
Drainage at endoscopic retrograde cholangiopancreatography (ECRP) is established as a safer approach than at percutaneous transhepatic cholangiography (PTC) because it has a lower risk of bile leak, infection and hemorrhage.
ECRP is the first approach to relieve malignant biliary obstruction but sometimes it is not technically possible to stent the patient by this approach, then a PTC needs to be undertaken.
Self expanding mesh metal stents (SEMS) were introduced back in the 1990s.
Problems can still arise with the use of covered stents such as cholecystitis, pancreatitis or tumor overgrowth at the end of the stent, and not all studies have shown that covered stents actually reduce the problems of tumor ingrowth and consequent stent occlusion.
EndoHPB can be deployed via an ERCP or PTC route.
By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may may delay tumor growth and the time before the stent lumen becomes blocked.
Thereby this allows increased periods between the need for intervention and further stent deployment.
If EndoHPB use of luminal RF is demonstrated to be effective in luminal tumor ablation, it may have an additional role as a form of neoadjuvant therapy in cholangiocarcinoma and pancreatic cancer.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Fase 1
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
Beskrivelse
Inclusion Criteria:
- Either gender greater than or equal to 18 years of age.
- Pancreatic Cancer or Cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced disease.
- Biliary Obstruction
- Subjects capable of giving informed consent
- Life expectancy of at least 3 months
Exclusion Criteria:
- Cardiac Pacemaker
- Patient unstable for endoscopy
- Inability to give informed consent
- Uncorrected coagulopathy
- Pregnancy
- Karnofsky score less than 40%
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Improvement in size(patency of bile duct) measured by cholangiography or cholangioscopy, immediately post ablation
Tidsramme: Baseline through visit 7
|
Baseline through visit 7
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. februar 2013
Primær færdiggørelse (Forventet)
1. februar 2015
Studieafslutning (Forventet)
1. februar 2015
Datoer for studieregistrering
Først indsendt
15. januar 2014
Først indsendt, der opfyldte QC-kriterier
20. januar 2014
Først opslået (Skøn)
23. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BRFA
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 .
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