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 type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 168 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 13 sites (Baltimore, Maryland and 12 other locations) |
| Status | Recruiting |
| Started | January 1, 2020 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | November 9, 2022 |
| Trial ID | NCT04078230 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
- Study coordinator: Jiang-Tao LI, PHD;MD
- Email: zjulijiangtao@163.com
- Phone: 86-15906686716
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
HAIC plus QL1706 and bevacizumab as first-line therapy for unresectable HER2-negative intrahepatic cholangiocarcinoma
This study tests a liver-directed chemotherapy plus immune therapy and a blood vessel blocker to see if it helps people with unresectable intrahepatic cholangiocarcinoma.
-
Durvalumab plus histotripsy for intrahepatic cholangiocarcinoma
This study tests whether adding histotripsy to ongoing durvalumab helps people with advanced intrahepatic cholangiocarcinoma by boosting the immune response and checking safety.
-
Dual-target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
This trial tests a ready-to-use CAR-NK cell therapy that targets HER2 and CEACAM5 in adults with unresectable or metastatic biliary tract cancers after standard therapy to see if it can help control the disease.
-
Chidamide plus chemotherapy and immunotherapy for advanced intrahepatic cholangiocarcinoma
This trial will test whether adding the oral drug chidamide to gemcitabine/cisplatin and an immune checkpoint inhibitor helps people with unresectable or metastatic intrahepatic cholangiocarcinoma who have not had prior systemic therapy.
-
VG2025 in intrahepatic cholangiocarcinoma
VG2025 is tested in adults with advanced intrahepatic cholangiocarcinoma to see if it can help control tumors and be safe.
-
MRI-guided adaptive single-session radiation for liver tumors (SABR)
This trial will test a single-session, MRI-guided adaptive high-dose radiation (SABR) for adults with primary or metastatic liver tumors to see if on-table MRI planning and replanning can treat tumors without a separate simulation visit.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.