Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
NCT ID: NCT04078230
Last Updated: 2022-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
168 participants
INTERVENTIONAL
2020-01-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Regional LymphAdenectomy
Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 a history of other malignant tumors;
* Liver function Child-Turcotte-Pugh score C;
* The investigator determined that it was not suitable for the study.
18 Years
80 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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The Johns Hopkins Hospital
Baltimore, Maryland, United States
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Renji Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Zhong Shan Hospital Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
Zhejiang cancer hospital
Hanzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jin He, MD
Role: primary
Zhiying Yang, MD
Role: primary
Zhiming Zhao, MD
Role: primary
Chao Liu, MD
Role: primary
Xianhai Mao, MD
Role: primary
Zhengxia Wang, MD
Role: primary
Jian Wang, MD
Role: primary
Wei Gong, MD
Role: primary
Houbao Liu, MD
Role: primary
Fuyu Li, MD
Role: primary
Xinbao Wang, MD
Role: primary
References
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Njei B. Changing pattern of epidemiology in intrahepatic cholangiocarcinoma. Hepatology. 2014 Sep;60(3):1107-8. doi: 10.1002/hep.26958. Epub 2014 Jul 28. No abstract available.
Zhang XF, Chakedis J, Bagante F, Chen Q, Beal EW, Lv Y, Weiss M, Popescu I, Marques HP, Aldrighetti L, Maithel SK, Pulitano C, Bauer TW, Shen F, Poultsides GA, Soubrane O, Martel G, Groot Koerkamp B, Guglielmi A, Itaru E, Pawlik TM. Trends in use of lymphadenectomy in surgery with curative intent for intrahepatic cholangiocarcinoma. Br J Surg. 2018 Jun;105(7):857-866. doi: 10.1002/bjs.10827. Epub 2018 Apr 14.
Weber SM, Ribero D, O'Reilly EM, Kokudo N, Miyazaki M, Pawlik TM. Intrahepatic cholangiocarcinoma: expert consensus statement. HPB (Oxford). 2015 Aug;17(8):669-80. doi: 10.1111/hpb.12441.
Kim DH, Choi DW, Choi SH, Heo JS, Kow AW. Is there a role for systematic hepatic pedicle lymphadenectomy in intrahepatic cholangiocarcinoma? A review of 17 years of experience in a tertiary institution. Surgery. 2015 Apr;157(4):666-75. doi: 10.1016/j.surg.2014.11.006. Epub 2015 Feb 12.
Shimada M, Yamashita Y, Aishima S, Shirabe K, Takenaka K, Sugimachi K. Value of lymph node dissection during resection of intrahepatic cholangiocarcinoma. Br J Surg. 2001 Nov;88(11):1463-6. doi: 10.1046/j.0007-1323.2001.01879.x.
Lendoire JC, Gil L, Imventarza O. Intrahepatic cholangiocarcinoma surgery: the impact of lymphadenectomy. Chin Clin Oncol. 2018 Oct;7(5):53. doi: 10.21037/cco.2018.07.02. Epub 2018 Jul 17.
Ribero D, Pinna AD, Guglielmi A, Ponti A, Nuzzo G, Giulini SM, Aldrighetti L, Calise F, Gerunda GE, Tomatis M, Amisano M, Berloco P, Torzilli G, Capussotti L; Italian Intrahepatic Cholangiocarcinoma Study Group. Surgical Approach for Long-term Survival of Patients With Intrahepatic Cholangiocarcinoma: A Multi-institutional Analysis of 434 Patients. Arch Surg. 2012 Dec;147(12):1107-13. doi: 10.1001/archsurg.2012.1962.
Doussot A, Lim C, Gomez-Gavara C, Fuks D, Farges O, Regimbeau JM, Azoulay D; AFC-IHCC Study Group. Multicentre study of the impact of morbidity on long-term survival following hepatectomy for intrahepatic cholangiocarcinoma. Br J Surg. 2016 Dec;103(13):1887-1894. doi: 10.1002/bjs.10296. Epub 2016 Sep 15.
Other Identifiers
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IHCC-china
Identifier Type: -
Identifier Source: org_study_id
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