Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Extend LymphAdenectomy 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
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
|
| No Intervention: Regional LymphAdenectomy Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12. |
Outcome Measures
Primary Outcome Measures
- Disease free survival (DFS) [5 years after surgery]
disease free survival
Secondary Outcome Measures
- 3-year Overall survival (OS) [3 years after surgery]
3-year overall survival
- Rate of Postoperative Complications (PC) [From the date of surgery to stitches off (up to 2 month)]
Postoperative Complications
- 5-year Overall survival (OS) [5 years after surgery]
5-year Overall survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients >18 years of age and ≤80 years of age;
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Preoperative imaging and laboratory examination for intrahepatic cholangiocarcinoma, intraoperative frozen and postoperative pathology confirmed as intrahepatic cholangiocarcinoma; preoperative imaging assessment is resectable;
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No obvious lymph node metastasis in preoperative imaging; or negative intraoperative lymph node biopsy
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Liver function Child-Turcotte-Pugh score A-B grade;
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Residual liver volume >30%; can tolerate radical hepatectomy
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The patient has autonomy, understands and voluntarily signs the written informed consent and is able to complete the follow-up plan;
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Sign the written informed consent form prior to the test screening.
Exclusion Criteria:
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The patient has obvious heart, lung, brain and kidney dysfunction that affects the treatment of intrahepatic cholangiocarcinoma;
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The patient has a history of other malignant tumors;
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Liver function Child-Turcotte-Pugh score C;
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The investigator determined that it was not suitable for the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Johns Hopkins Hospital | Baltimore | Maryland | United States | 10017 |
| 2 | China-Japan Friendship Hospital | Beijing | Beijing | China | |
| 3 | Chinese PLA General Hospital | Beijing | Beijing | China | |
| 4 | Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | China | |
| 5 | Hunan Provincial People's Hospital | Changsha | Hunan | China | |
| 6 | The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | China | |
| 7 | Renji Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai | China | |
| 8 | Xinhua Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai | China | |
| 9 | Zhong Shan Hospital Fudan University | Shanghai | Shanghai | China | |
| 10 | The First Affiliated Hospital of Xi 'an Jiaotong University | Xi'an | Shanxi | China | |
| 11 | West China Hospital Sichuan University | Chengdu | Sichuan | China | |
| 12 | The Second Affiliated Hospital Zhejiang University School of Medicine | Hanzhou | Zhejiang | China | 310009 |
| 13 | Zhejiang cancer hospital | Hanzhou | Zhejiang | China |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IHCC-china