Clinical trial NCT04078230: Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
Official title: Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intrahepatic Cholangiocarcinoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: resectable intrahepatic cholangiocarcinoma
Primary purpose: TREATMENT

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.

Detailed description: Expanding lymph node dissection can theoretically obtain more lymph node dissection. Obtaining enough lymph nodes can improve the accuracy of AJCC staging and accurately determine prognosis. However, it is unclear whether it will improve the prognosis of patients with lymph node dissection. According to literature reports and related studies, expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and left lymphoma expanded lymph node dissection includedstations 12, 1, 3, 7, and 8.

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.

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.

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: 5 years after surgery
Secondary outcomes:
measure: 3-year Overall survival (OS)
timeFrame: 3 years after surgery
measure: Rate of Postoperative Complications (PC)
timeFrame: From the date of surgery to stitches off (up to 2 month)
measure: 5-year Overall survival (OS)
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Zhong Shan Hospital Fudan University
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Hanzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hanzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.