A Phase 2 interventional study of Type WallFlex or Evolution biliary, stent system in Adenocarcinoma of Head of Pancreas, sponsored by Institut Paoli-Calmettes. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-26.
Sponsored by Institut Paoli-Calmettes · Phase 2, Interventional, and Treatment
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 6 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Efficacy of laying of a biliary stent for chemotherapy realization
Device: Type WallFlex or Evolution biliary, stent system
Laying of a stent biliary
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
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
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
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
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Institut Paoli-Calmettes