Clinical trial · Interventional
Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma
NCT02585856CI-TRIAL-00036185completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the procedure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PDT | Device | — | UNRESOLVED |
| stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PDT+stent
- description
- Patients with unresectable CCA are performed PDT and biliary stent with ERCP
- interventionNames
- Device: PDT
- Device: stent
- type
- PLACEBO_COMPARATOR
- label
- stent
- description
- Patients with unresectable CCA are performed biliary stent with ERCP alone
- interventionNames
- Device: stent
Primary outcomes (1)
- measure
- survival time
- timeFrame
- two years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Obtention of a written informed consent. * Patient over 18. * Patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under Spyglass, or by EUS-FNA. * Patient with Karnofsky score ≥ 50 % * Patient capable of fill in the quality of life questionnaire Exclusion Criteria: * No written informed consent. * Patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma. * Patients with porphyria or hypersensibility to porphyrins. * Pregnant, parturient or breastfeeding women. * Patient under 18.
References
Publications (5)
- BACKGROUNDRustagi T, Jamidar PA. Endoscopic treatment of malignant biliary strictures. Curr Gastroenterol Rep. 2015 Jan;17(1):426. doi: 10.1007/s11894-014-0426-9. PMID 25613178
- RESULTWagner A, Kiesslich T, Neureiter D, Friesenbichler P, Puespoek A, Denzer UW, Wolkersdorfer GW, Emmanuel K, Lohse AW, Berr F. Photodynamic therapy for hilar bile duct cancer: clinical evidence for improved tumoricidal tissue penetration by temoporfin. Photochem Photobiol Sci. 2013 Jun;12(6):1065-73. doi: 10.1039/c3pp25425a. Epub 2013 Apr 4. PMID 23558738
- RESULTLee TY, Cheon YK, Shim CS, Cho YD. Photodynamic therapy prolongs metal stent patency in patients with unresectable hilar cholangiocarcinoma. World J Gastroenterol. 2012 Oct 21;18(39):5589-94. doi: 10.3748/wjg.v18.i39.5589. PMID 23112552
- RESULTKahaleh M. Photodynamic therapy in cholangiocarcinoma. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S44-7. doi: 10.6004/jnccn.2012.0174. PMID 23055215
- RESULTLeggett CL, Gorospe EC, Murad MH, Montori VM, Baron TH, Wang KK. Photodynamic therapy for unresectable cholangiocarcinoma: a comparative effectiveness systematic review and meta-analyses. Photodiagnosis Photodyn Ther. 2012 Sep;9(3):189-95. doi: 10.1016/j.pdpdt.2012.03.002. Epub 2012 Apr 11. PMID 22959798