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NCT04078230Recruiting

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Source: ClinicalTrials.gov · Last updated 9 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
168 (estimated)
First submitted
26 Aug 2019
Start date
1 Jan 2020
Primary completion date
31 Dec 2027
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT number
NCT04078230

What you commit to

  • Study type: Interventional
  • Planned participants: 168
  • From 1 Jan 2020 to the primary completion date, 31 Dec 2027
  • 13 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;

Other

  • Liver function Child-Turcotte-Pugh score C;
  • The investigator determined that it was not suitable for the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
China-Japan Friendship Hospital
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BeijingChinaRecruiting
Chinese PLA General Hospital
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BeijingChinaRecruiting
Hunan Provincial People's Hospital
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ChangshaChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaRecruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
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HanzhouChinaRecruiting
Zhejiang Cancer Hospital
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HanzhouChinaRecruiting
The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaRecruiting
Zhong Shan Hospital Fudan University
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ShanghaiChinaRecruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
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ShanghaiChinaRecruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University
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ShanghaiChinaRecruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaRecruiting
The Johns Hopkins Hospital
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BaltimoreUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.