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Regional or Extended Lymphadenectomy for Intrahepatic Cholangiocarcinoma

This study is looking at the best way to remove lymph nodes during surgery for intrahepatic cholangiocarcinoma (a type of liver cancer). Doctors want to know if removing more lymph nodes (called "Extend LymphAdenectomy") helps patients live longer without the cancer coming back, compared to a standard lymph node removal. You might be able to join if you are between 18 and 80 years old, have been diagnosed with intrahepatic cholangiocarcinoma that can be removed by surgery, and don't show obvious signs of cancer spread to lymph nodes on scans. The main goal is to see how long patients live without the disease returning after surgery, measured over 5 years.

Study design
This study is an interventional study planning to enroll 168 participants. It compares two different surgical approaches for lymph node removal.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after surgery to track how long they live without the disease returning.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04078230

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Recruiting
NAAges 18–80InterventionalTreatment
Second Affiliated Hospital, Zhejiang University, School of Medicine
~168 participants
Updated 2022-11-09 on ClinicalTrials.gov
What's tested:Extend LymphAdenectomy

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease free survival (DFS)
Measured over 5 years after surgery

Conditions

Intrahepatic Cholangiocarcinoma

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Intrahepatic Cholangiocarcinoma

NCT04078230

Where you'd take part

This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, Chinastudy coordinator listed

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hanzhou, Zhejiang, Chinastudy coordinator listed

    Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan, Chinano site contact published

    Recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, Chinano site contact published

    Recruiting

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

    Guangzhou, Guangdong, Chinano site contact published

    Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Jiang-Tao LI, PHD;MD
[email protected]
86-15906686716
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Disease free survival (DFS)5 years after surgery

    disease free survival