Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Recruiting now · Not applicable

Conditions studied: Intrahepatic Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT04078230

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

168

Starts

2020-01-01

Expected to finish

2027-12-31

Last updated by the study team

2022-11-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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