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NCT Number: NCT04078230

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extend LymphAdenectomy

Procedure

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 outcomes

  1. Disease free survival (DFS)

    Time frame: 5 years after surgery

    disease free survival

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiang-Tao LI, PHD;MD

CONTACT

[email protected]

86-15906686716

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 6, 2019
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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