Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05519319

Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma

Led by First People's Hospital of Hangzhou · Updated on 2023-02-21

70

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A median survival period of 3 to 6 months is the prognosis for patients with advanced, unresectable EHCC. For patients with locally advanced, unresectable EHCC, effective management of tumor growth is the only option to increase stent patency and survival time. In patients with cholangiocarcinoma, photodynamic therapy (PDT) is therapy that has been shown to improve stent patency and overall survival (OS). Endoscopic radiofrequency ablation (RFA) has been demonstrated in numerous studies to prolong the life spans of individuals with malignant biliary obstruction . In the literature, comparing the clinical efficacy and adverse outcomes of these two endoscopic procedures is rare.

CONDITIONS

Official Title

Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed cholangiocarcinoma
  • Unresectable cholangiocarcinoma due to local infiltration of major vessels confirmed by CT, MRCP, or EUS
  • No previous treatment for cholangiocarcinoma
  • Adequate bone marrow and organ function: white blood cells >4.0^9/L, hemoglobin >90 g/L, platelets >75^9/L, serum creatinine <2.0 mg/dl
  • Karnofsky performance status score 65
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Imaging shows distant metastasis in liver, lung, or other organs
  • Presence of other malignant tumors
  • Pregnant or nursing women
  • Previous gastrointestinal diversion surgery
  • Participation in another study within one month before enrollment
  • Alcohol or substance abuse or poor compliance as judged by a doctor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

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Research Team

J

Jianfeng Yang, Doctor

CONTACT

H

Hayat Khizar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma | DecenTrialz