NCT04078230 Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
| NCT ID | NCT04078230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Intrahepatic Cholangiocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2020-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04078230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intrahepatic Cholangiocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04078230 currently recruiting?
Yes, NCT04078230 is actively recruiting participants. Contact the research team at zjulijiangtao@163.com for enrollment information.
Where is the NCT04078230 trial being conducted?
This trial is being conducted at Baltimore, United States, Beijing, China, Beijing, China, Guangzhou, China and 9 additional locations.
Who is sponsoring the NCT04078230 clinical trial?
NCT04078230 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 168 participants.