Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas (PROPAC)
Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.
Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).
However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.
In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).
It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
-
Marseille, Frankreich, 13009
- Institut Paoli Calmettes
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patient aged > 18 ans and ≤ 75 ans
- Suspicion of adenocarcinoma of the head of the pancreas leading to the placement of a biliary stent
- Either metastatic or "borderline" (at the limit of resectability) or locally advanced
- PS = 0 or 1
- Hematological laboratory parameters (ANC ≥ 1.5 ** 10 9 / l (/ mm3), platelets ≥ 100 ** 10 9 / l (G / L)) and kidney (calculated creatinin clearance> 60 ml / min)
- Jaundice (bilirubin> 20 mmol / L) by compressing the lower part of the bile duct (dilatation of the extrahepatic bile duct)
- Written informed Consent
- Affiliation to social security
Exclusion Criteria:
- Pregnant or lactating woman or without contraception (for child bearing potential women)
- Patient deprived of liberty or under supervision of a guardian
- Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
- Contra-indication for study procedure
- Predictable technical impossibility to position a stent endoscopically (prior upper GI surgery)
- Life expectancy assumed less than 3 months
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: First attempt stenting (T0 = date of the first act)
Efficacy of laying of a biliary stent for chemotherapy realization
|
Laying of a stent biliary
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Determine the percentage of patients who, at Day 28 after the first attempt stenting (T0 = date of the first act), has received or is able to receive FOLFIRINOX.
Zeitfenster: At day 28 after the laying of the biliary stent
|
At day 28 after the laying of the biliary stent
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Rate of biliary infection starting within 3 months after insertion of the prosthesis
Zeitfenster: From the laying of the biliary stent to 3 months follow up
|
From the laying of the biliary stent to 3 months follow up
|
|
Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)
Zeitfenster: From the laying of the biliary stent to 3 months follow up
|
From the laying of the biliary stent to 3 months follow up
|
|
Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.
Zeitfenster: From the laying of the biliary stent to 3 months follow up
|
From the laying of the biliary stent to 3 months follow up
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jean-Luc RAOUL, MD, PHD, Institut Paoli-Calmettes
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PROPAC-IPC 2012 006
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