Photodynamic therapy plus stenting versus stenting alone in nonresectable cholangiocarcinoma: a randomized prospective study (Ortner 2003)
- Population
- Patients with histologically confirmed nonresectable cholangiocarcinoma.
- Design
- Prospective, open-label, randomised, multicentre study with a group sequential design. After endoscopic or percutaneous double stenting, patients with histologically confirmed cholangiocarcinoma were randomised to group A (stenting then photodynamic therapy: Photofrin 2 mg/kg intravenously two days before intraluminal photoactivation, wavelength 630 nm, light dose 180 J/cm2, repeated for residual tumour in the bile duct) or group B (stenting alone). Primary outcome survival time; secondary outcomes cholestasis and quality of life. The study was terminated prematurely; the authors state that photodynamic therapy proved so superior that further randomisation was deemed unethical. The abstract reports median survival in days (493 versus 98 days, group A versus group B, P < 0.0001).
- Primary endpoint
- OS
- Arms
- Stenting alone (group B) (control, n = 19): Endoscopic or percutaneous double stenting without photodynamic therapy
- Stenting plus photodynamic therapy (group A) (experimental, n = 20): Stenting, then Photofrin 2 mg/kg intravenously and intraluminal photoactivation at 630 nm, 180 J/cm2
- People
- Ortner ME