Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

— LND for ICC  

Official title:

Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796819
• Other study ID #: XJTU1AFCRC2017SJ-007
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: December 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy

• The tumor is limited in the liver with no distant metastasis, and the primary disease is resectable

• Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found no nodal swelling or enlargement

Exclusion Criteria:

• The primary disease is unresectable with or without distant metastasis

• The liver function or general condition of patients does not permit surgery

• Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed

• Patients aged below 18 or older than 65 would be excluded

• Pregnant women would not be enrolled

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Procedure:
• lymphadenectomy
Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (7)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Binzhou Medical University, Nanchang University, Ningxia Medical University, Shaanxi Provincial People's Hospital, Shaanxi University of Chinese Medicine, The Third Affiliated Hospital of Beijing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year recurrence rate	compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy	1 year after surgery (up to 1 year)
Primary	3-year recurrence rate	compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy	3 years after surgery (up to 3 years)
Secondary	Postoperative morbidity	investigate the postoperative morbidity, such as hepatic failure, postoperative bleeding, superficial and deep site infection between lymphadenectomy and no lymphadenectomy groups	From the date of surgery to stitches off (up to 1 month)
Secondary	1-year overall survival	compare the 1-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy	1 year after surgery (up to 1 year)
Secondary	3-year overall survival	compare the 3-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy	3 years after surgery (up to 3 years)