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Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma (LND for ICC)

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ClinicalTrials.gov Identifier: NCT03796819
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 10, 2019
Sponsor:
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

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024


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.



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796819


Contacts
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Contact: Xu-Feng Zhang, MD, PhD 86 29 85323900 xfzhang125@126.com
Contact: Hong-Fan Ding, MD 86-29-85323626 1209025584@qq.com

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
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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

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03796819     History of Changes
Other Study ID Numbers: XJTU1AFCRC2017SJ-007
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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