Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Not Applicable

Recruiting

• Conditions: Intrahepatic Cholangiocarcinoma
• Interventions: Procedure: Extend LymphAdenectomy

• Registration Number: NCT04078230
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

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.

Detailed Description

Expanding lymph node dissection can theoretically obtain more lymph node dissection. Obtaining enough lymph nodes can improve the accuracy of AJCC staging and accurately determine prognosis. However, it is unclear whether it will improve the prognosis of patients with lymph node dissection. According to literature reports and related studies, expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and left lymphoma expanded lymph node dissection includedstations 12, 1, 3, 7, and 8.

In summary, standardize the extent of lymph node dissection in intrahepatic cholangiocarcinoma, and obtain enough lymph node dissection under the premise of controlling the complication rate, which is helpful for accurate TNM staging, accurate judgment of prognosis and improvement of survival time. Improve prognosis.

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2020-01-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-09
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extend LymphAdenectomy	Extend LymphAdenectomy	Expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and stations 12, 1, 3, 7, and 8 for left liver tumors

Primary Outcome Measures

Name	Time	Method
Disease free survival (DFS)	5 years after surgery	disease free survival

Secondary Outcome Measures

Name	Time	Method
3-year Overall survival (OS)	3 years after surgery	3-year overall survival
Rate of Postoperative Complications (PC)	From the date of surgery to stitches off (up to 2 month)	Postoperative Complications
5-year Overall survival (OS)	5 years after surgery	5-year Overall survival

Trial Locations

Locations (13)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China

Renji Hospital Affiliated to Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hanzhou, Zhejiang, China

Zhejiang cancer hospital; 🇨🇳 Hanzhou, Zhejiang, China

Zhong Shan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China

The Affiliated Hospital of Inner Mongolia Medical University; 🇨🇳 Hohhot, Inner Mongolia, China

The First Affiliated Hospital of Xi 'an Jiaotong University; 🇨🇳 Xi'an, Shanxi, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China

West China Hospital Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China