BridgeMD
New treatment option for Perihilar Cholangiocarcinoma
Official title Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
ClinicalTrials.gov ID: NCT05546372
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Patients who potentially qualify for curative resection of pCCA.
- pCCA eligible for liver transplantation.
- Life-expectancy less than 3 months.
- ERCP and PTC technically not feasible.
- Uncontrolled coagulopathy (PTT \>1,5x prolonged or thrombocytes below 40\ 10E9/L).
- Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days.
See the full eligibility criteria
- 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.
- Patients who potentially qualify for curative resection of pCCA.
- pCCA eligible for liver transplantation.
- Life-expectancy less than 3 months.
- ERCP and PTC technically not feasible.
- Uncontrolled coagulopathy (PTT \>1,5x prolonged or thrombocytes below 40\ 10E9/L).
- Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days.
- Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.
- Patients who are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.