Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Study Overview
=================
Brief Summary
-----------------
Intrahepatic cholangiocarcinoma (ICC) is one of the common malignant tumors. Lymph node metastasis is an important factor affecting the poor prognosis of intrahepatic cholangiocarcinoma. The eighth edition of the AJCC guidelines recommends at least 6 lymph nodes to be used for staging. The American Hepatobiliary and Pancreatic Association also recommends the removal of hilar lymph nodes as part of the radical surgery for intrahepatic cholangiocarcinoma. However, some scholars have found that patients with regional lymph nodes have similar survival rates. This contradictory result has prompted more scholars to conduct clinical research to explore the necessity and standardization of lymph node dissection in intrahepatic cholangiocarcinoma.

Detailed Description
-----------------
Expanding lymph node dissection can theoretically obtain more lymph node dissection. Obtaining enough lymph nodes can improve the accuracy of AJCC staging and accurately determine prognosis. However, it is unclear whether it will improve the prognosis of patients with lymph node dissection. According to literature reports and related studies, expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and left lymphoma expanded lymph node dissection includedstations 12, 1, 3, 7, and 8. In summary, standardize the extent of lymph node dissection in intrahepatic cholangiocarcinoma, and obtain enough lymph node dissection under the premise of controlling the complication rate, which is helpful for accurate TNM staging, accurate judgment of prognosis and improvement of survival time. Improve prognosis.

Official Title
-----------------
Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Conditions
-----------------
Intrahepatic Cholangiocarcinoma

Intervention / Treatment
-----------------
* Procedure: Extend LymphAdenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years of age and ≤80 years of age; Preoperative imaging and laboratory examination for intrahepatic cholangiocarcinoma, intraoperative frozen and postoperative pathology confirmed as intrahepatic cholangiocarcinoma; preoperative imaging assessment is resectable; No obvious lymph node metastasis in preoperative imaging; or negative intraoperative lymph node biopsy Liver function Child-Turcotte-Pugh score A-B grade; Residual liver volume >30%; can tolerate radical hepatectomy The patient has autonomy, understands and voluntarily signs the written informed consent and is able to complete the follow-up plan; Sign the written informed consent form prior to the test screening. Exclusion Criteria: The patient has obvious heart, lung, brain and kidney dysfunction that affects the treatment of intrahepatic cholangiocarcinoma; The patient has a history of other malignant tumors; Liver function Child-Turcotte-Pugh score C; The investigator determined that it was not suitable for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: resectable intrahepatic cholangiocarcinoma
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extend LymphAdenectomy<br>Expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and stations 12, 1, 3, 7, and 8 for left liver tumors | Procedure: Extend LymphAdenectomy<br>* Expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and stations 12, 1, 3, 7, and 8 for left liver tumors<br>|
| No Intervention: Regional LymphAdenectomy<br>Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival (DFS) | disease free survival | 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year Overall survival (OS) | 3-year overall survival | 3 years after surgery | 
| Rate of Postoperative Complications (PC) | Postoperative Complications | From the date of surgery to stitches off (up to 2 month) | 
| 5-year Overall survival (OS) | 5-year Overall survival | 5 years after surgery |