Adenocarcinoma of Head of Pancreas
Conditions
Keywords
Laying of the biliary stent
Brief summary
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.
Interventions
DEVICEType WallFlex or Evolution biliary, stent system
Laying of a stent biliary
Sponsors
Institut Paoli-Calmettes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | At day 28 after the laying of the biliary stent |
Secondary
| Measure | Time frame |
|---|---|
| Rate of biliary infection starting within 3 months after insertion of the prosthesis | From the laying of the biliary stent to 3 months follow up |
| Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts) | 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. | From the laying of the biliary stent to 3 months follow up |
Countries
France
Outcome results
None listed