Surgery for Intrahepatic Cholangiocarcinoma with Lymph Node Dissection

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 13 sites (Baltimore, Maryland and 12 other locations)
• Trial ID: NCT04078230 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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 performed: 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.

Eligibility 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 this trial is running

Baltimore, Maryland and 12 other locations

• 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)
• 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

Conditions Intrahepatic Cholangiocarcinoma