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Intrahepatic CholangiocarcinomaNCT04078230

Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma

A study testing Extend LymphAdenectomy in people with Intrahepatic Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 13 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma
What is being tested?
Extend LymphAdenectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
13 sitesin 2 countries
Study dates
1 Jan 2020to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jiang-Tao LI, PHD;MD contact

86-15906686716

zjulijiangtao@163.com

13 sites in 2 countries

China12 sites, 12 recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

    Zhiying Yang, MD

    Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Zhiming Zhao, MD

    Recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan

    Xianhai Mao, MD

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan

    Fuyu Li, MD

    Recruiting

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

    Guangzhou, Guangdong

    Chao Liu, MD

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 310009

    Jiang-tao Li, MD, 86-13666651245, zjulijiangtao@163.com

    Recruiting

  • Zhejiang cancer hospital

    Hanzhou, Zhejiang

    Xinbao Wang, MD

    Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

    Zhengxia Wang, MD

    Recruiting

  • Renji Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality

    Jian Wang, MD

    Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality

    Wei Gong, MD

    Recruiting

  • Zhong Shan Hospital Fudan University

    Shanghai, Shanghai Municipality

    Houbao Liu, MD

    Recruiting

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi

    Zhimin Geng, MD, gengzhimin@mail.xjtu.edu.cn

    Recruiting

Other trials in China

United States1 site, 1 recruiting

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 10017

    Jin He, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Extend LymphAdenectomy
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extend LymphAdenectomyProcedure or surgery

    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

Study groups in NCT04078230
Study groupRoleWhat they receive
Extend LymphAdenectomyExperimentalExpanded 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
Receives: Procedure: Extend LymphAdenectomy
Regional LymphAdenectomyNo interventionRegional lymph node dissection for intrahepatic cholangiocarcinoma included station 12.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival (DFS)

    disease free survival

    Measured: 5 years after surgery

Secondary outcomes (3)

  1. 3-year Overall survival (OS)

    3-year overall survival

    Measured: 3 years after surgery

  2. Rate of Postoperative Complications (PC)

    Postoperative Complications

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

  3. 5-year Overall survival (OS)

    5-year Overall survival

    Measured: 5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
resectable intrahepatic cholangiocarcinoma
Masking
Single blind
Who is masked
Participant
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04078230
Sponsor's protocol ID
IHCC-china
Status last verified
Jan 2022
First submitted
26 Aug 2019
Last updated
9 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24327308

  • 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.

    PubMed 29656380

  • 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.

    PubMed 26172134

  • 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.

    PubMed 25682172

  • 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.

    PubMed 11683741

  • 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.

    PubMed 30180752

  • 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.

    PubMed 22910846

  • 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.

    PubMed 27629502

Questions about this trial

What is this clinical trial studying?

A study testing Extend LymphAdenectomy in people with Intrahepatic Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiang-Tao LI, PHD;MD (86-15906686716, zjulijiangtao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (DFS) (time frame: 5 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04078230, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.

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