Clinical trial NCT01439685: Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP
Official title: Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Retrospective and Prospective Analysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cholangiocarcinoma
Keywords: Cholangiocarcinoma
PDT
Photodynamic Therapy
Bile Duct
Bile Duct Obstruction
Jaundice
Biliary Stent
ERCP
Obstructive Jaundice
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects suffering from Cholangiocarcinoma

Brief summary: This study entails retrospective and prospective review of data from a database protocol. Data gathered will be then analyzed for a set amount of patients. In this study, the investigators will compare biliary stenting vs. biliary stenting plus photodynamic therapy (PDT) and assess if PDT can improve quality of life and prolong survival.

Detailed description: Successful palliation of biliary obstruction is the main goal for reducing morbidity and mortality in patients with biliary disease and biliary obstruction related to cholangiocarcinoma. Surgical biliary bypass is unfortunately complicated by a 30-day postoperative mortality rate of between 7 and 24%. Moreover, because of recovery time the quality of life following surgery is only improved in a minority. At present endoscopic insertion of a plastic or metal stent is the method of choice to relieve obstructive jaundice without the high morbidity and mortality associated with surgery. But this relief is unfortunately temporary since stents tend to become obstructed and the fact that effective biliary drainage in the proximal lesion is challenging. Photodynamic Therapy (PDT) is a new therapeutic approach that specifically targets neoplastic cells. This therapy 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.

A prospective, randomized and controlled trial study by Ortner et all confirmed the significant advantage of PDT with regard to relief of jaundice, quality of life, and survival. The improvement of survival in the randomized PDT group was so impressive that it was believed unethical to continue with randomization after the first 39 patients (20 and 19 in each group).Previously, the principal investigator conducted such a study (and also conducted Endoscopic Retrograde Cholangiopancreatography with PDT) at the University of Virginia, and would continue to conduct these procedures, as well as the study at WCMC.

Eligibility criteria: Inclusion Criteria:

* Any patient who has undergone ERCP (Endoscopic Retrograde Cholangiopancreatography) and Biliary stenting with or without Photodynamic Therapy.
* Biliary disorder or obstruction due to Cholangiocarcinoma.
* Above 18 years of age.

Exclusion Criteria:

* Any patient who has not undergone ERCP and biliary stenting.
* Not diagnosed with Cholangiocarcinoma.
* Below 18 years of age

Primary outcomes:
measure: Number of days patients survived post treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talreja JP, Kahaleh M. Photodynamic therapy for cholangiocarcinoma. Gut Liver. 2010 Sep;4 Suppl 1(Suppl 1):S62-6. doi: 10.5009/gnl.2010.4.S1.S62. Epub 2010 Sep 10.
citation: Talreja JP, DeGaetani M, Sauer BG, Kahaleh M. Photodynamic therapy for unresectable cholangiocarcinoma: contribution of single operator cholangioscopy for targeted treatment. Photochem Photobiol Sci. 2011 Jul;10(7):1233-8. doi: 10.1039/c0pp00259c. Epub 2011 Apr 21.