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

NCT02487836 | Completed Phase 2

• 1 other identifier: PROPAC-IPC 2012 006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Laying of the biliary stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

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

OTHER

Efficacy of laying of a biliary stent for chemotherapy realization

Device: Type WallFlex or Evolution biliary, stent system

Interventions

Type WallFlex or Evolution biliary, stent system DEVICE

Laying of a stent biliary

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Related Links

• official web site of the sponsor

Study Officials

• Jean-Luc RAOUL, MD, PHD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 2, 2015
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 26, 2016

Record last verified: 2013-10

Locations

FR (1)