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

Adenocarcinoma of Head of Pancreas Clinical Trial

— PROPAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487836
• Other study ID #: PROPAC-IPC 2012 006
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2015
• Last updated: February 25, 2016
• Start date: October 2013
• Est. completion date: October 2015

Study information

• Verified date: October 2013
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Head of Pancreas

Intervention

Device:
• Type WallFlex or Evolution biliary, stent system
Laying of a stent biliary

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)		From the laying of the biliary stent to 3 months follow up	No
Secondary	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	No

External Links

•   official web site of the sponsor