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Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04078230
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Procedure: Extend LymphAdenectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: resectable intrahepatic cholangiocarcinoma
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: 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
Procedure: 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

No Intervention: Regional LymphAdenectomy
Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.



Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: 5 years after surgery ]
    disease free survival


Secondary Outcome Measures :
  1. 3-year Overall survival (OS) [ Time Frame: 3 years after surgery ]
    3-year overall survival

  2. Rate of Postoperative Complications (PC) [ Time Frame: From the date of surgery to stitches off (up to 2 month) ]
    Postoperative Complications

  3. 5-year Overall survival (OS) [ Time Frame: 5 years after surgery ]
    5-year Overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078230


Contacts
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Contact: Jiang-Tao LI, PHD;MD 86-13666651245 zjulijiangtao@163.com

Locations
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United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 10017
Contact: Jin He, MD         
China, Beijing
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China
Contact: Zhiying Yang, MD         
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China
Contact: Zhiming Zhao, MD         
China, Guangdong
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China
Contact: Chao Liu, MD         
China, Hunan
Hunan Provincial People's Hospital Recruiting
Changsha, Hunan, China
Contact: Xianhai Mao, MD         
China, Inner Mongolia
The Affiliated Hospital of Inner Mongolia Medical University Recruiting
Hohhot, Inner Mongolia, China
Contact: Zhengxia Wang, MD         
China, Shanghai
Renji Hospital Affiliated to Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China
Contact: Jian Wang, MD         
Xinhua Hospital Affiliated to Shanghai Jiao Tong University Recruiting
Shanghai, Shanghai, China
Contact: Wei Gong, MD         
Zhong Shan Hospital Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Houbao Liu, MD         
China, Shanxi
The First Affiliated Hospital of Xi 'an Jiaotong University Recruiting
Xi'an, Shanxi, China
Contact: Zhimin Geng, MD       gengzhimin@mail.xjtu.edu.cn   
China, Sichuan
West China Hospital Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Fuyu Li, MD         
China, Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine Recruiting
Hanzhou, Zhejiang, China, 310009
Contact: Jiang-tao Li, MD    86-13666651245    zjulijiangtao@163.com   
Zhejiang cancer hospital Recruiting
Hanzhou, Zhejiang, China
Contact: Xinbao Wang, MD         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Publications of Results:

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04078230    
Other Study ID Numbers: IHCC-china
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms