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

NCT01439685 | Withdrawn

• 1 other identifier: 1106011779
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Biliary Stent plus Photodynamic therapy

Biliary Stent plus Photodynamic therapy

Biliary Stent group

Biliary Stent group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects suffering from Cholangiocarcinoma

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 21103297 BACKGROUND

• 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.

  PMID: 21512706 RESULT

MeSH Terms

Conditions

Cholangiocarcinoma; Cholestasis; Jaundice; Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Michel Kahaleh, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Advanced Endoscopy

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 23, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)