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Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT02526771
Recruitment Status : Unknown
Verified March 2016 by ShenFeng, Eastern Hepatobiliary Surgery Hospital.
Recruitment status was:  Recruiting
First Posted : August 18, 2015
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

Brief Summary:
The aim of this study is to compare the surgical outcomes of conventional lymph node dissection with unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholangiocarcinoma Procedure: conventional lymph node dissection Procedure: unconventional lymph node dissection Not Applicable

Detailed Description:
Intrahepatic cholangiocarcinoma (ICC) is one of the primary liver cancer, which has higher malignant, more difficult treatment and worse prognosis compared to hepatocellular carcinoma and its incidence continues to rise. The main radical treatment is surgical resection, however, postoperative recurrence rate is extremely high. The 3-year recurrence rate is more than 50%. It is reported that lymph node metastasis rate of ICC is as high as 20% to 65%, which is the most significant factor of the poor prognosis. The probability of lymph node metastasis is 13% when lymph nodes metastasis were not found preoperative or intraoperative. It is highly controversial whether or not to undergo conventional lymph node dissection when lymph nodes metastasis were not found preoperative or intraoperative . A number of researchers approved of lymph node dissection at that situation. However, some authors such as Kim suggest that lymph node resection is not necessary. Others such as Yang think should consider in different condition. Clark CJ thinks that the evidence for dissection or not of lymph node is insufficient in view of the above reasons, the investigators have planned to implement a randomized controlled study to confirm the prognostic value of conventional or unconventional lymph node dissection during resection of Intrahepatic cholangiocarcinoma.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma
Study Start Date : August 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: conventional lymph node dissection
conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Procedure: conventional lymph node dissection
conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma

Active Comparator: unconventional lymph node dissection
unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Procedure: unconventional lymph node dissection
unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma




Primary Outcome Measures :
  1. overall survival [ Time Frame: five years ]

Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: five years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients > 18 years and <=70 years of age.
  • Diagnosis of intrahepatic cholangiocarcinoma ( through imaging, serology, intraoperative frozen, etc.)
  • No lymph node metastasis preoperatively or intraoperatively.
  • Tumors can be completely resected.
  • Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value, alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  • Patients who can understand this trial and have signed information consent. Exclusion Criteria:Lymph node metastasis preoperatively.
  • Tumors can not be resected .
  • Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction, which may affect the treatment of Intrahepatic cholangiocarcinoma.
  • Patients with a medical history of other malignant tumors.
  • Subjects participating in other clinical trials.
  • liver function:Child C.

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): NCT02526771


Contacts
Contact: Shen Feng, MD 0086-021-25070805 shenfengdfgd@yahoo.com.cn
Contact: Wu Dong, MD 0086-021-25070765 wuyuz@yahoo.com.cn

Locations
China, Shanghai
Eastern hepatobilliary surgery hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Shen Feng, MD    0086-021-25070805    shenfengdfgd@yahoo.com.cn   
Contact: Wu Dong, MD    0086-021-25070765    wuyuz@yahoo.com.cn   
Principal Investigator: Shen Feng, MD         
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Shen Feng, MD Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospital, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT02526771     History of Changes
Other Study ID Numbers: EHBHLND-2015-8-10
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
lymph node dissection

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms