Clinical trial NCT02487836: Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
Official title: Phase II Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma of Head of Pancreas
Keywords: Laying of the biliary stent
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At day 28 after the laying of the biliary stent
Secondary outcomes:
measure: Rate of biliary infection starting within 3 months after insertion of the prosthesis
timeFrame: From the laying of the biliary stent to 3 months follow up
measure: Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)
timeFrame: From the laying of the biliary stent to 3 months follow up
measure: Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.
timeFrame: From the laying of the biliary stent to 3 months follow up
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Luc RAOUL, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: