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

NCT ID: NCT02487836

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-10-31

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.

Conditions

Adenocarcinoma of Head of Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First attempt stenting (T0 = date of the first act)

Efficacy of laying of a biliary stent for chemotherapy realization

Group Type: OTHER

Type WallFlex or Evolution biliary, stent system

Intervention Type: DEVICE

Laying of a stent biliary

Interventions

Type WallFlex or Evolution biliary, stent system

Laying of a stent biliary

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc RAOUL, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli Calmettes

Marseille, , France

Countries

France

Related Links

http://www.institutpaolicalmettes.fr

official web site of the sponsor

Other Identifiers

PROPAC-IPC 2012 006

Identifier Type: -

Identifier Source: org_study_id