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


N/A
18 Years
N/A
Open (Enrolling)
Both
Cholangiocarcinoma

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control

Outcome Measure:

Number of days patients survived post treatment

Outcome Description:

The group that receives PDT plus stenting will be compared to the group that received stenting only and their survival duration would be evaluated.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michel Kahaleh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

1106011779

NCT ID:

NCT01439685

Start Date:

July 2011

Completion Date:

July 2014

Related Keywords:

  • Cholangiocarcinoma
  • Cholangiocarcinoma
  • PDT
  • Photodynamic Therapy
  • Bile Duct
  • Bile Duct Obstruction
  • Jaundice
  • Biliary Stent
  • ERCP
  • Obstructive Jaundice
  • Cholangiocarcinoma

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021