Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
1 other identifier
interventional
168
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
November 9, 2022
January 1, 2022
8 years
August 26, 2019
November 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival (DFS)
disease free survival
5 years after surgery
Secondary Outcomes (3)
3-year Overall survival (OS)
3 years after surgery
Rate of Postoperative Complications (PC)
From the date of surgery to stitches off (up to 2 month)
5-year Overall survival (OS)
5 years after surgery
Study Arms (2)
Extend LymphAdenectomy
EXPERIMENTALExpanded 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
NO INTERVENTIONRegional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
The Johns Hopkins Hospital
Baltimore, Maryland, 10017, 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, 310009, China
Zhejiang cancer hospital
Hanzhou, Zhejiang, China
Related Publications (8)
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.
PMID: 24327308RESULTZhang 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.
PMID: 29656380RESULTWeber 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.
PMID: 26172134RESULTKim 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.
PMID: 25682172RESULTShimada 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.
PMID: 11683741RESULTLendoire 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.
PMID: 30180752RESULTRibero 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.
PMID: 22910846RESULTDoussot 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.
PMID: 27629502RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2019
First Posted
September 6, 2019
Study Start
January 1, 2020
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
November 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share