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

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas

Conditions
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Adenocarcinoma of Head of Pancreas

Intervention / Treatment
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* Device: Type WallFlex or Evolution biliary, stent system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First attempt stenting (T0 = date of the first act)<br>Efficacy of laying of a biliary stent for chemotherapy realization | Device: Type WallFlex or Evolution biliary, stent system<br>* Laying of a stent biliary<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laying of the biliary stent