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

Primary Purpose

Adenocarcinoma of Head of Pancreas

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Type WallFlex or Evolution biliary, stent system

About this trial

This is an interventional treatment trial for Adenocarcinoma of Head of Pancreas focused on measuring Laying of the biliary stent

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut Paoli Calmettes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

Efficacy of laying of a biliary stent for chemotherapy realization

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of biliary infection starting within 3 months after insertion of the prosthesis

Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)

Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.

Full Information

NCT ID

NCT02487836

First Posted

June 25, 2015

Last Updated

February 25, 2016

Sponsor

Institut Paoli-Calmettes

1. Study Identification

Unique Protocol Identification Number

NCT02487836

Brief Title

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

Acronym

PROPAC

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

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of Head of Pancreas

Keywords

Laying of the biliary stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Other

Arm Description

Efficacy of laying of a biliary stent for chemotherapy realization

Intervention Type

Device

Intervention Name(s)

Type WallFlex or Evolution biliary, stent system

Intervention Description

Laying of a stent biliary

Primary Outcome Measure Information:

Title

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.

Time Frame

At day 28 after the laying of the biliary stent

Secondary Outcome Measure Information:

Title

Rate of biliary infection starting within 3 months after insertion of the prosthesis

Time Frame

From the laying of the biliary stent to 3 months follow up

Title

Prosthetic dysfunction within 3 months (recurrence of jaundice with dilated bile ducts)

Time Frame

From the laying of the biliary stent to 3 months follow up

Title

Complication (s) other (s) (bleeding, perforation, ...) possibly attached (s) endoscopic treatment within 3 months.

Time Frame

From the laying of the biliary stent to 3 months follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Luc RAOUL, MD, PHD

Organizational Affiliation

Institut Paoli-Calmettes

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut Paoli Calmettes

City

Marseille

ZIP/Postal Code

13009

Country

France

12. IPD Sharing Statement

Links:

URL

http://www.institutpaolicalmettes.fr

Description

official web site of the sponsor

Learn more about this trial

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

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