Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years or older.

• Capable of providing written and oral informed consent.

• Histological or cytological proof of perihilar CCA (adenocarcinoma).

• Perihilar biliary obstruction with an indication for drainage with uSEMS.\*

• Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).

⁃ Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included.

Locations
Other Locations
Netherlands
Amsterdam UMC location VUmc
RECRUITING
Amsterdam
Contact Information
Primary
Jeska Fritzsche
j.a.fritzsche@amsterdamumc.nl
+31204440613
Time Frame
Start Date: 2023-11-09
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 98
Treatments
Experimental: Endobiliary RFA + stent placement
Active_comparator: Stent placement only
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov

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