Recruiting

Observational Study

Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Code:

NCT04078230

Conditions

Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Extend LymphAdenectomy

Study Details

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.

Conditions

Intrahepatic Cholangiocarcinoma

Study ID

NCT04078230

Start date

Jan 1, 2020

Status verified date

Jan, 2022

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

no intervention: Regional LymphAdenectomy

Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.

Interventions

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 measure

  • Disease free survival (DFS) [ Time Frame: 5 years after surgery ]

Central Contacts and Locations

Central contacts

Jiang-Tao LI, PHD;MD

86-15906686716zjulijiangtao@163.com

Locations

The Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 10017

More Information

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Last update posted

Nov 9, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University on 2022-11-09.