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Efficacy and Safety of Photodynamic Therapy for Unresectable Cholangiocarcinoma

NCT02585856 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-12-19

No results posted yet for this study

Summary

The aim of this study is to investigate the efficacy of photodynamic therapy (PDT) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (HRQoL) by comparing PDT puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of PDT by observing the complications after the procedure.

Conditions

Interventions

DEVICE

PDT

Patients with unresectable CCA are performed PDT with ERCP after porfimer sodium （chongqing ray high medical instrument co., LTD，Chongqing, China) i.v. at a dose of 2 mg/kg at 48 h. PDT procedure: for light distribution, flexible cylindrical diffuser probes mounted on 400-mm quartz fibres with an active distal tip length of 2 cm （chongqing ray high medical instrument co., LTD，Chongqing, China) is used. The light source was a diode laser system with a maximum power output of 2 Wand a wavelength of 633.3 nm. The power emitted by the diffuser tip was calibrated to 400 mW/cm before PDT was administered using an integrating sphere power meter. The mean irradiation time was 452 s (range: 400-600 s), using a power density of 300-400 mW/cm and an energy dose of 180-200 J/cm (of diffuser length).

DEVICE

stent

Patients with unresectable CCA are performed with ERCP, one or several plastic biliary stents (Boston Scientific Corporation, MA,USA) are inserted to ensure adequate decompression and bile drainage.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Principal Investigators

  • Xiaofeng Zhang, M.S · First People's Hospital of Hangzhou

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT02585856 on ClinicalTrials.gov