Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Intrahepatic Cholangiocarcinoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: routine hepatoduodenal lymphadenectomyMasking: Double (Participant, Outcomes Assessor)Masking Description: patients would not be told about the lymphadenectomyPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery rem...

Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform LND only in select circumstances. The utilization of LND may not only vary among different institutions, but also by geographic region. Specifically, data from East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While several case series from Asia have noted that most centers do not regularly perform LND,other data from the West suggest that LND may be becoming more routine. Despite the lack of consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual recommends that the nodal basin be staged. Disease-specific staging for ICC was first introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated 8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to stage a patient with ICC. The previous multi-institutional retrospective study from the investigators have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.

Tracking Information

NCT #
NCT03796819
Collaborators
  • Ningxia Medical University
  • Nanchang University
  • Binzhou Medical University
  • Shaanxi Provincial People's Hospital
  • Shaanxi University of Chinese Medicine
  • The Third Affiliated Hospital of Beijing University
Investigators
Study Chair: Yi Lv, MD, PhD First Affiliated Hospital Xi'an Jiaotong University Principal Investigator: Xu-Feng Zhang, MD,PhD First Affiliated Hospital Xi'an Jiaotong University