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Clinical Trials in China / NCT04078230
Recruiting Not applicable

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

NCT04078230 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2020-01-01
Last updated
2022-11-09

Condition(s) studied

Intrahepatic Cholangiocarcinoma

Investigational drug(s) / intervention(s)

Extend LymphAdenectomy

Extend 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

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Disease free survival (DFS) — 5 years after surgery
    disease free survival

Trial sites (13)

FacilityCityRegionStatus
The Johns Hopkins Hospital Baltimore Maryland Recruiting
China-Japan Friendship Hospital Beijing Beijing Municipality Recruiting
Chinese PLA General Hospital Beijing Beijing Municipality Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou Guangdong Recruiting
Hunan Provincial People's Hospital Changsha Hunan Recruiting
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University Shanghai Shanghai Municipality Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University Shanghai Shanghai Municipality Recruiting
Zhong Shan Hospital Fudan University Shanghai Shanghai Municipality Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University Xi’an Shanxi Recruiting
West China Hospital Sichuan University Chengdu Sichuan Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine Hanzhou Zhejiang Recruiting
Zhejiang cancer hospital Hanzhou Zhejiang Recruiting

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Other trials for the same condition

HAIC Plus QL1706 & Bevacizumab in Unresectable HER2-Negative ICC Recruiting
Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study Recruiting
Exploring the Efficacy and Safety of Tislelizumab in Combination With S-1 in the Treatment of Patients With Postoperative Recurrent High-risk Intrahepatic Cholangiocarcinoma Recruiting
Chidamide Combined With Chemotherapy and Immunotherapy as First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma Recruiting
Phase II-III Clinical Trial of PD1 Antibody (Toripalimab), Lenvatinib and GEMOX Neoadjuvant Treatment for Resectable Intrahepatic Cholangiocarcinoma With High-risk Recurrence Factors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04078230 on ClinicalTrials.gov ↗ ← All trials in China