Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas (PROPAC)

Institut Paoli-Calmettes

Status and phase

Completed

Phase 2

Conditions

Adenocarcinoma of Head of Pancreas

Treatments

Device: Type WallFlex or Evolution biliary, stent system

Study type

Interventional

Funder types

Other

Identifiers

NCT02487836

PROPAC-IPC 2012 006

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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