Study Summary
This trial is studying the standardization of lymph node dissection in ICC.
Eligible Conditions
- Intrahepatic Cholangiocarcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 3 years after surgery
3 years after surgery
3-year Overall survival (OS)
5 years after surgery
5-year Overall survival (OS)
Disease free survival (DFS)
Month 2
Rate of Postoperative Complications (PC)
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Regional LymphAdenectomy
1 of 2
Extend LymphAdenectomy
1 of 2
Active Control
Experimental Treatment
168 Total Participants · 2 Treatment Groups
Primary Treatment: Extend LymphAdenectomy · No Placebo Group · N/A
Extend LymphAdenectomy
Procedure
Experimental Group · 1 Intervention: Extend LymphAdenectomy · Intervention Types: ProcedureRegional LymphAdenectomyNoIntervention Group · 1 Intervention: Regional LymphAdenectomy · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years after surgery
Who is running the clinical trial?
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityLead Sponsor
669 Previous Clinical Trials
1,674,411 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
9 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Eligibility Criteria
Age 18 - 80 · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a Child-Turcotte-Pugh score of A or B.
You have a residual liver volume of 30% or more
You have no obvious lymph node metastasis in preoperative imaging; or negative intraoperative lymph node biopsy.
References
- Lendoire, Javier C., Luis Gil, and Oscar Imventarza. 2018. “Intrahepatic Cholangiocarcinoma Surgery: The Impact of Lymphadenectomy”. Chinese Clinical Oncology. AME Publishing Company. doi:10.21037/cco.2018.07.02.
- Shimada, M, Y Yamashita, S Aishima, K Shirabe, K Takenaka, and K Sugimachi. 2001. “Value of Lymph Node Dissection During Resection of Intrahepatic Cholangiocarcinoma”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1046/j.0007-1323.2001.01879.x.
- Ribero, Dario. 2012. “Surgical Approach for Long-term Survival of Patients with Intrahepatic Cholangiocarcinoma”. Archives of Surgery. American Medical Association (AMA). doi:10.1001/archsurg.2012.1962.
- Njei, Basile. 2014. “Changing Pattern of Epidemiology in Intrahepatic Cholangiocarcinoma”. Hepatology. Wiley. doi:10.1002/hep.26958.
- Kim, Dong Hun, Dong Wook Choi, Seong Ho Choi, Jin Seok Heo, and Alfred Wei-Chieh Kow. 2015. “Is There a Role for Systematic Hepatic Pedicle Lymphadenectomy in Intrahepatic Cholangiocarcinoma? A Review of 17 Years of Experience in a Tertiary Institution”. Surgery. Elsevier BV. doi:10.1016/j.surg.2014.11.006.
- Zhang, X -F, J Chakedis, F Bagante, Q Chen, E W Beal, Y Lv, M Weiss, et al.. 2018. “Trends in Use of Lymphadenectomy in Surgery with Curative Intent for Intrahepatic Cholangiocarcinoma”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.10827.
- Weber, Sharon M., Dario Ribero, Eileen M. O'Reilly, Norihiro Kokudo, Masaru Miyazaki, and Timothy M. Pawlik. 2015. “Intrahepatic Cholangiocarcinoma: Expert Consensus Statement”. Hpb. Elsevier BV. doi:10.1111/hpb.12441.
- Doussot, A, C Lim, C Gómez-Gavara, D Fuks, O Farges, J M Regimbeau, D Azoulay, et al.. 2016. “Multicentre Study of the Impact of Morbidity on Long-term Survival Following Hepatectomy for Intrahepatic Cholangiocarcinoma”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.10296.
- 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. Erratum In: Br J Surg. 2017 Dec;104(13):1895.
- 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.
- 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.
- 2020. "Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04078230.
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