No registrations found.
ID
Source
Brief title
Health condition
Parihilair cholangiocarcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of the proposed pilot study is to evaluate whether eRFA is feasible, safe in patients with unresectable perihilar cholangiocarcinoma.
Secondary outcome
Recurrence of biliary obstruction, quality of life
Background summary
It is hypothesized that eRFA leads to increased stent patency, fewer re-interventions, fewer (permanent) external drains, and consequently increased quality of life. Currently eRFA for CCA has only been investigated in retrospective and small prospective pilot-studies. The primairy aim of the proposed pilot study is to evaluate whether eRFA is feasible and safe in patients with unresectable perihilar cholangiocarcinoma .
Study objective
It is hypothesized that eRFA leads to increased stent patency, fewer re-interventions, fewer (permanent) external drains, and consequently increased quality of life.
Study design
o Baseline: consultation + questionnaire + laboratory test
o 1 day after eRFA: consultation
o 2 weeks after eRFA: consultation + laboratory test
o 1 month and every 3 months after eRFA: consultation + questionnaire + laboratory test
Intervention
Endobiliary RFA
Inclusion criteria
- 18 years or older.
- Capable of providing written and oral informed consent.
- Histological or cytological proof of perihilar CCA (adenocarcinoma)*
- Biliary obstruction with indication for drainage (symptomatic (itch or cholangitis) or necessary for systemic therapy).
- 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).
Exclusion criteria
- Resectable CCA.
- Intrahepatic or distal CCA, or gallbladder cancer.
- CCA eligible for liver transplantation.
- Life-expectancy less than 3 months.
- ERCP and PTD technically not feasible.
- Uncontrolled coagulopathy (PTT >1,5x prolonged or thrombocytes below 40 10E9/L).
- Carcinoma other than adenocarcinoma.
- Implantable pacemaker and implantable cardioverter/ defibrillator
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9144 |
| Other | METC AMC : METC 2020_217 |