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| Name | Class |
|---|---|
| Ningxia Medical University | OTHER |
| Nanchang University | OTHER |
| Binzhou Medical University | OTHER |
| Shaanxi Provincial People's Hospital |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lymphadenectomy | Experimental | This group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection |
|
| No lymphadenectomy | No Intervention | This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lymphadenectomy | Procedure | Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year recurrence rate | compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy | 1 year after surgery (up to 1 year) |
| 3-year recurrence rate | compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy | 3 years after surgery (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity | investigate the postoperative morbidity, such as hepatic failure, postoperative bleeding, superficial and deep site infection between lymphadenectomy and no lymphadenectomy groups | From the date of surgery to stitches off (up to 1 month) |
| 1-year overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Lv, MD, PhD | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Xu-Feng Zhang, MD,PhD | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008197 | Lymph Node Excision |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Shaanxi University of Chinese Medicine | OTHER |
| The Third Affiliated Hospital of Beijing University | UNKNOWN |
routine hepatoduodenal lymphadenectomy
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patients would not be told about the lymphadenectomy
compare the 1-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy |
| 1 year after surgery (up to 1 year) |
| 3-year overall survival | compare the 3-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy | 3 years after surgery (up to 3 years) |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |