Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma (LND for ICC)

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

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.

Study Overview

• Status: Completed
• Conditions: Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Procedure: lymphadenectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: lymphadenectomy; This group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection	Procedure: lymphadenectomy; Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection
NO_INTERVENTION: No lymphadenectomy; This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Shaanxi Provincial People's Hospital; Ningxia Medical University; Nanchang University; Shaanxi University of Chinese Medicine; Binzhou Medical University; 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ACTUAL): August 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: January 6, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: surgery; prognosis; intrahepatic cholangiocarcinoma; lymph node metastasis; lymphadenectomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma
• Other Study ID Numbers: XJTU1AFCRC2017SJ-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No