Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04078230
• Other study ID #: IHCC-china
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Jiang-Tao LI, PHD;MD
• Phone: 86-15906686716
• Email: zjulijiangtao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	West China Hospital Sichuan University	Chengdu	Sichuan
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hanzhou	Zhejiang
China	Zhejiang cancer hospital	Hanzhou	Zhejiang
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Renji Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	Zhong Shan Hospital Fudan University	Shanghai	Shanghai
China	The First Affiliated Hospital of Xi 'an Jiaotong University	Xi'an	Shanxi
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Countries where clinical trial is conducted

United States,  China, 

References & Publications (8)

Doussot A, Lim C, Gómez-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):18 — View 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 — View 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. Review. — View 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. — View 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 — View 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. — View 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. — View 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 lymph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)	disease free survival	5 years after surgery
Secondary	3-year Overall survival (OS)	3-year overall survival	3 years after surgery
Secondary	Rate of Postoperative Complications (PC)	Postoperative Complications	From the date of surgery to stitches off (up to 2 month)
Secondary	5-year Overall survival (OS)	5-year Overall survival	5 years after surgery