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Clinical Effect and Safety of PDT and RFA for Unresectable EHCC

NCT04301999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-09-01

No results posted yet for this study

Summary

The prognosis of patients with advanced unresectable EHCC is very poor with a median survival of 3 to 6 months. Active control of tumor growth is the key to extending stent patency and survival for patients with unresectable locally advanced EHCC. Photodynamic therapy (PDT) is by far the only modality that has shown to improve stent patency as well as over survival (OS) in patients with cholangiocarcinoma. In recent years, many studies have shown that endoscopic radiofrequency ablation (RFA) extends stent patency and possibly the survival of patients with malignant biliary obstruction. However, there are few reports comparing the clinical efficacy and advers event of these two endoscopic treatment.

Conditions

Interventions

PROCEDURE

Photodynamic therapy

The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visualradiography. The dilation catheter was then withdrawn to leavethe PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s.

PROCEDURE

radiofrequency ablation

an RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Principal Investigators

  • Jianfeng Yang · 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
2020-03-01
Primary Completion
2021-08-27
Completion
2021-08-27

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 NCT04301999 on ClinicalTrials.gov