Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

November 7, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Zhiying Yang, MD
      • Beijing, Beijing, China
        • Recruiting
        • Chinese PLA General hospital
        • Contact:
          • Zhiming Zhao, MD
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
          • Xianhai Mao, MD
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
          • Zhengxia Wang, MD
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Renji Hospital Affiliated to Shanghai Jiao Tong University
        • Contact:
          • Jian Wang, MD
      • Shanghai, Shanghai, China
        • Recruiting
        • Xinhua Hospital Affiliated To Shanghai Jiao Tong University
        • Contact:
          • Wei Gong, MD
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhong Shan Hospital Fudan University
    • Shanxi
      • Xi'an, Shanxi, China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital Sichuan University
        • Contact:
          • Fuyu Li, MD
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Hanzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 10017
        • Recruiting
        • The Johns Hopkins Hospital
        • Contact:
          • Jin He, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival (DFS)
Time Frame: 5 years after surgery
disease free survival
5 years after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2027

Study Completion (ANTICIPATED)

December 31, 2027

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

September 3, 2019

First Posted (ACTUAL)

September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHCC-china

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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