RecruitingNot ApplicableNCT04078230

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

168 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • Patients \>18 years of age and ≤80 years of age;
  • Preoperative imaging and laboratory examination for intrahepatic cholangiocarcinoma, intraoperative frozen and postoperative pathology confirmed as intrahepatic cholangiocarcinoma; preoperative imaging assessment is resectable;
  • No obvious lymph node metastasis in preoperative imaging; or negative intraoperative lymph node biopsy
  • Liver function Child-Turcotte-Pugh score A-B grade;
  • Residual liver volume \>30%; can tolerate radical hepatectomy
  • The patient has autonomy, understands and voluntarily signs the written informed consent and is able to complete the follow-up plan;
  • Sign the written informed consent form prior to the test screening.

Exclusion Criteria4

  • The patient has obvious heart, lung, brain and kidney dysfunction that affects the treatment of intrahepatic cholangiocarcinoma;
  • The patient has a history of other malignant tumors;
  • Liver function Child-Turcotte-Pugh score C;
  • The investigator determined that it was not suitable for the study.

Interventions

PROCEDUREExtend LymphAdenectomy

Expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and stations 12, 1, 3, 7, and 8 for left liver tumors


Locations(13)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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

Guangzhou, Guangdong, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Renji Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Zhong Shan Hospital Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Zhejiang cancer hospital

Hanzhou, Zhejiang, China

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NCT04078230


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