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Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

RecruitingNAAges 18 Years - 80 YearsAllSecond Affiliated Hospital, Zhejiang University, …
NCT04078230 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Extend LymphAdenectomy
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Where

13 sites
The Johns Hopkins Hospital
Baltimore, United States
China-Japan Friendship Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
Hunan Provincial People's Hospital
Changsha, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
Renji Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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