It is hypothesized that eRFA leads to increased stent patency, fewer re-interventions, fewer (permanent) external drains, and consequently increased quality of life.
ID
Bron
Verkorte titel
Aandoening
Parihilair cholangiocarcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary aim of the proposed pilot study is to evaluate whether eRFA is feasible, safe in patients with unresectable perihilar cholangiocarcinoma.
Achtergrond van het onderzoek
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 .
Doel van het onderzoek
It is hypothesized that eRFA leads to increased stent patency, fewer re-interventions, fewer (permanent) external drains, and consequently increased quality of life.
Onderzoeksopzet
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
Onderzoeksproduct en/of interventie
Endobiliary RFA
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9144 |
| Ander register | METC AMC : METC 2020_217 |