A Phase 3 interventional study of ERCP and Photodynamic Therapy and ERCP only in Cholangiocarcinoma, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-03.
Sponsored by Weill Medical College of Cornell University · Phase 3, Interventional, and Treatment
This research study is a phase III double arm, multicenter, randomized controlled clinical trial comparing endoscopic retrograde cholangiopancreatography (ERCP) and stenting plus photodynamic therapy (PDT) versus ERCP with stenting alone in adult patients with unresectable cholangiocarcinoma.
The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).
The study objectives are to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time of patients with unresectable cholangiocarcinoma and to assess the effect of PDT on both cholestasis and health-related quality of life (HRQoL).
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have adequate organ and marrow function as defined below:
Exclusion Criteria:
Endoscopic Retrograde Cholangio Pancreatography (ERCP) and stenting combined with Photodynamic Dynamic Therapy ERCP and PDT
Procedure: ERCP and Photodynamic Therapy · Procedure: ERCP only
Endoscopic Retrograde Cholangio Pancreatography (ERCP) with stenting alone
Procedure: ERCP only
Photodynamic Therapy is a new therapeutic approach that specifically targets neoplastic cells. This therapy has been used in other tumors as a local treatment and involves the intravenous administration of a photosensitizing agent followed by activation of the agent by illumination with non-thermal light of a specific wavelength, resulting in cell death from direct cytotoxicity and ischemic necrosis. Cytotoxicity is directly proportional to tissue oxygenation.
Endoscopic retrograde cholangiopancreatography and stenting.
Survival time in each group will be compared as well as effect of each treatment arm on cholestasis and HRQoL
Time frame: 2.4 years
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University