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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First attempt stenting (T0 = date of the first act) | Other | Efficacy of laying of a biliary stent for chemotherapy realization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Type WallFlex or Evolution biliary, stent system | Device | Laying of a stent biliary |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc RAOUL, MD, PHD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Paoli Calmettes | Marseille | 13009 | France |
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| Label | URL |
|---|---|
| official web site of the sponsor | View source |
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| 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 |