Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy (PDT) During ERCP

Cholangiocarcinoma Clinical Trial

— PDT  

Official title:

Comparison of Biliary Stenting Alone vs. Stenting With Photodynamic Therapy During Endoscopic Retrograde Cholangiopancreatography (ERCP): A Retrospective and Prospective Analysis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01439685
• Other study ID #: 1106011779
• Status: Withdrawn
• Phase: N/A
• First received: September 20, 2011
• Last updated: June 1, 2015
• Start date: July 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Cholangiocarcinoma

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 20 — View Citation

Talreja JP, Kahaleh M. Photodynamic therapy for cholangiocarcinoma. Gut Liver. 2010 Sep;4 Suppl 1:S62-6. doi: 10.5009/gnl.2010.4.S1.S62. Epub 2010 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days patients survived post treatment	The group that receives PDT plus stenting will be compared to the group that received stenting only and their survival duration would be evaluated.	2 years	No