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

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

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.

Study Overview

• Status: Completed
• Conditions: Adenocarcinoma of Head of Pancreas
• Intervention / Treatment: Device: Type WallFlex or Evolution biliary, stent system

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13009
    • Institut Paoli Calmettes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes
• Investigators: Principal Investigator: Jean-Luc RAOUL, MD, PHD, Institut Paoli-Calmettes

Publications and helpful links

Helpful Links

• official web site of the sponsor

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: February 25, 2016
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Laying of the biliary stent
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: PROPAC-IPC 2012 006