Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04078230
Status
Recruiting
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Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jan 1, 2020
Status verified
Jan 2022
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Johns Hopkins HospitalBaltimoreMaryland10017
Jin He, MD

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By research site
The Johns Hopkins Hospital· Baltimore, MD

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