Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT04078230

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2022-11-09

168

Participants Needed

13

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Intrahepatic cholangiocarcinoma (ICC) is one of the common malignant tumors. Lymph node metastasis is an important factor affecting the poor prognosis of intrahepatic cholangiocarcinoma. The eighth edition of the AJCC guidelines recommends at least 6 lymph nodes to be used for staging. The American Hepatobiliary and Pancreatic Association also recommends the removal of hilar lymph nodes as part of the radical surgery for intrahepatic cholangiocarcinoma. However, some scholars have found that patients with regional lymph nodes have similar survival rates. This contradictory result has prompted more scholars to conduct clinical research to explore the necessity and standardization of lymph node dissection in intrahepatic cholangiocarcinoma.

CONDITIONS

Official Title

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients between 18 and 80 years old
  • Confirmed intrahepatic cholangiocarcinoma by preoperative imaging, intraoperative frozen, and postoperative pathology
  • Tumor assessed as resectable by preoperative imaging
  • No obvious lymph node metastasis on preoperative imaging or negative intraoperative lymph node biopsy
  • Liver function classified as Child-Turcotte-Pugh grade A or B
  • Residual liver volume greater than 30% and able to tolerate radical hepatectomy
  • Patient is capable of understanding, voluntarily consents, and can complete follow-up
  • Signed written informed consent before screening
Not Eligible

You will not qualify if you...

  • Significant heart, lung, brain, or kidney dysfunction affecting treatment
  • History of other malignant tumors
  • Liver function classified as Child-Turcotte-Pugh grade C
  • Investigator judges patient unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

The Johns Hopkins Hospital

Baltimore, Maryland, United States, 10017

Actively Recruiting

2

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

3

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

4

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Actively Recruiting

5

Hunan Provincial People's Hospital

Changsha, Hunan, China

Actively Recruiting

6

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Actively Recruiting

7

Renji Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Actively Recruiting

8

Xinhua Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Actively Recruiting

9

Zhong Shan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

10

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Actively Recruiting

11

West China Hospital Sichuan University

Chengdu, Sichuan, China

Actively Recruiting

12

The Second Affiliated Hospital Zhejiang University School of Medicine

Hanzhou, Zhejiang, China, 310009

Actively Recruiting

13

Zhejiang cancer hospital

Hanzhou, Zhejiang, China

Actively Recruiting

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Research Team

J

Jiang-Tao LI, PHD;MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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