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Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Primary Purpose

Intrahepatic Cholangiocarcinoma

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Extend LymphAdenectomy

About this trial

This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Johns Hopkins HospitalRecruiting
China-Japan Friendship HospitalRecruiting
Chinese PLA General HospitalRecruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityRecruiting
Hunan Provincial People's HospitalRecruiting
The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
Renji Hospital Affiliated to Shanghai Jiao Tong UniversityRecruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong UniversityRecruiting
Zhong Shan Hospital Fudan UniversityRecruiting
The First Affiliated Hospital of Xi 'an Jiaotong UniversityRecruiting
West China Hospital Sichuan UniversityRecruiting
The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
Zhejiang cancer hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Extend LymphAdenectomy

Regional LymphAdenectomy

Arm Description

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 lymph node dissection for intrahepatic cholangiocarcinoma included station 12.

Outcomes

Primary Outcome Measures

Disease free survival (DFS)

disease free survival

Secondary Outcome Measures

3-year Overall survival (OS)

3-year overall survival

Rate of Postoperative Complications (PC)

Postoperative Complications

5-year Overall survival (OS)

5-year Overall survival

Full Information

NCT ID

NCT04078230

First Posted

August 26, 2019

Last Updated

November 7, 2022

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04078230

Brief Title

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Official Title

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 31, 2027 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intrahepatic Cholangiocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

resectable intrahepatic cholangiocarcinoma

Masking

Participant

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Extend LymphAdenectomy

Arm Type

Experimental

Arm Description

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

Arm Title

Regional LymphAdenectomy

Arm Type

No Intervention

Arm Description

Regional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.

Intervention Type

Procedure

Intervention Name(s)

Extend LymphAdenectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease free survival (DFS)

Description

disease free survival

Time Frame

5 years after surgery

Secondary Outcome Measure Information:

Title

3-year Overall survival (OS)

Description

3-year overall survival

Time Frame

3 years after surgery

Title

Rate of Postoperative Complications (PC)

Description

Postoperative Complications

Time Frame

From the date of surgery to stitches off (up to 2 month)

Title

5-year Overall survival (OS)

Description

5-year Overall survival

Time Frame

5 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiang-Tao LI, PHD;MD

Phone

86-15906686716

zjulijiangtao@163.com

Facility Information:

Facility Name

The Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

10017

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin He, MD

Facility Name

China-Japan Friendship Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiying Yang, MD

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhiming Zhao, MD

Facility Name

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chao Liu, MD

Facility Name

Hunan Provincial People's Hospital

City

Changsha

State/Province

Hunan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xianhai Mao, MD

Facility Name

The Affiliated Hospital of Inner Mongolia Medical University

City

Hohhot

State/Province

Inner Mongolia

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhengxia Wang, MD

Facility Name

Renji Hospital Affiliated to Shanghai Jiao Tong University

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Wang, MD

Facility Name

Xinhua Hospital Affiliated to Shanghai Jiao Tong University

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Gong, MD

Facility Name

Zhong Shan Hospital Fudan University

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Houbao Liu, MD

Facility Name

The First Affiliated Hospital of Xi 'an Jiaotong University

City

Xi'an

State/Province

Shanxi

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhimin Geng, MD

gengzhimin@mail.xjtu.edu.cn

Facility Name

West China Hospital Sichuan University

City

Chengdu

State/Province

Sichuan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fuyu Li, MD

Facility Name

The Second Affiliated Hospital Zhejiang University School of Medicine

City

Hanzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiang-tao Li, MD

Phone

86-13666651245

zjulijiangtao@163.com

Facility Name

Zhejiang cancer hospital

City

Hanzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinbao Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24327308

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.

Results Reference

result

PubMed Identifier

29656380

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.

Results Reference

result

PubMed Identifier

26172134

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.

Results Reference

result

PubMed Identifier

25682172

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.

Results Reference

result

PubMed Identifier

11683741

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.

Results Reference

result

PubMed Identifier

30180752

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.

Results Reference

result

PubMed Identifier

22910846

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.

Results Reference

result

PubMed Identifier

27629502

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. Erratum In: Br J Surg. 2017 Dec;104(13):1895.

Results Reference

result

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Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

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