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NCT Number: NCT02487836

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.

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Key information

Conditions

Adenocarcinoma of Head of Pancreas

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Paoli Calmettes

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type WallFlex or Evolution biliary, stent system

Device

Laying of a stent biliary

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.

    Time frame: At day 28 after the laying of the biliary stent

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: PROPAC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 2, 2015
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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