Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma
A Randomized Controlled Study of Conventional or Unconventional Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 1, 2016
March 1, 2016
2.3 years
August 10, 2015
March 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
five years
Secondary Outcomes (1)
disease-free survival
five years
Study Arms (2)
conventional lymph node dissection
EXPERIMENTALconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
unconventional lymph node dissection
ACTIVE COMPARATORunconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Interventions
conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shen Feng, MD
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice president of the Eastern Hepatobiliary Surgery Hospital
Study Record Dates
First Submitted
August 10, 2015
First Posted
August 18, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 1, 2016
Record last verified: 2016-03