Clinical trial Recruiting at 13 sites Interventional Ages 18 to 80

Surgery for Intrahepatic Cholangiocarcinoma with Lymph Node Dissection

Official title: Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT04078230 · Data updated 2026-11-12

This study is testing if a more extensive lymph node removal during surgery for liver cancer can help patients live longer and have better outcomes compared to standard surgery.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment168 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations13 sites (Baltimore, Maryland and 12 other locations)
StatusRecruiting
StartedJanuary 1, 2020
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedNovember 9, 2022
Trial IDNCT04078230 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 80 with resectable intrahepatic cholangiocarcinoma and no significant lymph node metastasis.

Probably not a fit

Patients with significant heart, lung, brain, or kidney dysfunction, or those with Child-Turcotte-Pugh score C liver function will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of extended lymphadenectomy during the surgical resection of intrahepatic cholangiocarcinoma (ICC). The study aims to standardize the extent of lymph node dissection to improve the accuracy of staging and prognosis for patients with ICC. By comparing outcomes between standard and extended lymph node dissection, researchers hope to determine if a more extensive approach can enhance survival rates while managing complication risks. The trial includes patients aged 18 to 80 with resectable ICC and no significant lymph node metastasis.

Why it matters

Potential benefit: If successful, this approach could lead to improved survival rates and more accurate prognostic assessments for patients with intrahepatic cholangiocarcinoma.

How similar studies have gone: While there is ongoing debate regarding the necessity of extensive lymph node dissection in ICC, previous studies have shown mixed results, indicating that this approach is still under investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The Johns Hopkins Hospital
    Baltimore, Maryland, United States
    Recruiting
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality, China
    Recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing Municipality, China
    Recruiting
  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong, China
    Recruiting
  • Hunan Provincial People's Hospital
    Changsha, Hunan, China
    Recruiting
  • The Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia, China
    Recruiting
Show 7 more locations
  • Renji Hospital Affiliated to Shanghai Jiao Tong University
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Zhong Shan Hospital Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting
  • The First Affiliated Hospital of Xi 'an Jiaotong University
    Xi’an, Shanxi, China
    Recruiting
  • West China Hospital Sichuan University
    Chengdu, Sichuan, China
    Recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hanzhou, Zhejiang, China
    Recruiting
  • Zhejiang cancer hospital
    Hanzhou, Zhejiang, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.