Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma (LND for ICC)

• ClinicalTrials.gov Identifier: NCT03796819
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: December 9, 2021
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• 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
• Information provided by (Responsible Party): First Affiliated Hospital Xi'an Jiaotong University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Intrahepatic Cholangiocarcinoma	Procedure: lymphadenectomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 260 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: routine hepatoduodenal lymphadenectomy
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: patients would not be told about the lymphadenectomy
• Primary Purpose: Treatment
• Official Title: Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma
• Actual Study Start Date: January 10, 2019
• Actual Primary Completion Date: August 1, 2021
• Actual Study Completion Date: December 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 1-year recurrence rate [ 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
2. 3-year recurrence rate [ 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

Secondary Outcome Measures :

1. Postoperative morbidity [ 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
2. 1-year overall survival [ 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
3. 3-year overall survival [ 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Shaanxi

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

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

More Information

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT03796819
• Other Study ID Numbers: XJTU1AFCRC2017SJ-007
• First Posted: January 8, 2019
• Last Update Posted: December 9, 2021
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:

intrahepatic cholangiocarcinoma; surgery; lymphadenectomy; lymph node metastasis; prognosis

Additional relevant MeSH terms:

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms