The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
NCT Number: NCT03796819
The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study 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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Xi'an, Shaanxi, 710061, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection
Time frame: 1 year after surgery (up to 1 year)
compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
Time frame: 3 years after surgery (up to 3 years)
compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
Time frame: From the date of surgery to stitches off (up to 1 month)
investigate the postoperative morbidity, such as hepatic failure, postoperative bleeding, superficial and deep site infection between lymphadenectomy and no lymphadenectomy groups
Time frame: 1 year after surgery (up to 1 year)
compare the 1-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
Time frame: 3 years after surgery (up to 3 years)
compare the 3-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
First Affiliated Hospital Xi'an Jiaotong University
Other
Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma
Acronym: LND for ICC
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