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Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

NCT02725073 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-04-14

No results posted yet for this study

Summary

To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.

Conditions

  • Treatment Response
  • Adverse Events
  • Feasibility

Interventions

PROCEDURE

Photodynamic therapy

Photolon (Belmedpreparaty, Minsk, Republic of Belarus), was administered intravenously at a dose of 2.5 mg/kg at 3 hours before illumination. After advancing a catheter (7 F inner sheath of a plastic stent delivery catheter \[MAJ-1419; Olympus America, Center Valley, Pa., USA\]) across the biliary stricture using a 0.035-in guidewire, the cylindrical diffuser is inserted into a catheter at the level of the stricture to be treated. Photoactivation (660 nm with a light dose of 100-150J/cm2, and fluence of 0.8-1W/cm2; UPL- FDT; LEMT Research \& Development Private Unitary Enterprise, Minsk, Republic of Belarus) is performed

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Do Hyun Park, Md, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725073 on ClinicalTrials.gov