Intrahepatic CholangiocarcinomaLND for ICCNCT03796819
Routine Lymphadenectomy for Intrahepatic Cholangiocarcinoma
A study testing lymphadenectomy in people with Intrahepatic Cholangiocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy
- The tumor is limited in the liver with no distant metastasis, and the primary disease is resectable
- Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found no nodal swelling or enlargement
Who cannot join
- The primary disease is unresectable with or without distant metastasis
- The liver function or general condition of patients does not permit surgery
- Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed
- Patients aged below 18 or older than 65 would be excluded
- Pregnant women would not be enrolled
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
About this study
Official title: Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma
The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.
Read the detailed description
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform LND only in select circumstances. The utilization of LND may not only vary among different institutions, but also by geographic region. Specifically, data from East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While several case series from Asia have noted that most centers do not regularly perform LND,other data from the West suggest that LND may be becoming more routine. Despite the lack of consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual recommends that the nodal basin be staged. Disease-specific staging for ICC was first introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated 8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to stage a patient with ICC.
The previous multi-institutional retrospective study from the investigators have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- lymphadenectomy
- Keywords
- intrahepatic cholangiocarcinoma, surgery, lymphadenectomy, lymph node metastasis, prognosis
- Medical subject headings
- Cholangiocarcinoma, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphadenectomyProcedure or surgery
Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection
| Study group | Role | What they receive |
|---|---|---|
| lymphadenectomy | Experimental | This group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection Receives: Procedure: lymphadenectomy |
| No lymphadenectomy | No intervention | This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence rate
compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
Measured: 1 year after surgery (up to 1 year)
3-year recurrence rate
compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
Measured: 3 years after surgery (up to 3 years)
Secondary outcomes (3)
Postoperative morbidity
investigate the postoperative morbidity, such as hepatic failure, postoperative bleeding, superficial and deep site infection between lymphadenectomy and no lymphadenectomy groups
Measured: From the date of surgery to stitches off (up to 1 month)
1-year overall survival
compare the 1-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
Measured: 1 year after surgery (up to 1 year)
3-year overall survival
compare the 3-year overall survival rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
Measured: 3 years after surgery (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start10 Jan 2019
- Primary completion1 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- routine hepatoduodenal lymphadenectomy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ningxia Medical University, Nanchang University, Binzhou Medical University, Shaanxi Provincial People's Hospital, Shaanxi University of Chinese Medicine, The Third Affiliated Hospital of Beijing University
- Responsible party
- Sponsor
- Investigators
- Yi Lv, MD, PhD, Study chair, First Affiliated Hospital Xi'an Jiaotong UniversityXu-Feng Zhang, MD,PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796819
- Sponsor's protocol ID
- XJTU1AFCRC2017SJ-007
- Acronym
- LND for ICC
- Status last verified
- Aug 2019
- First submitted
- 6 Jan 2019
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Routine Lymphadenectomy on Prognosis of Patients Undergoing Curative Resection for Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT03796819
- Acronym / sponsor ID
- LND for ICC / XJTU1AFCRC2017SJ-007
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- intrahepatic cholangiocarcinoma, surgery, lymphadenectomy, lymph node metastasis, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Ningxia Medical University, Nanchang University, Binzhou Medical University, Shaanxi Provincial People's Hospital, Shaanxi University of Chinese Medicine, The Third Affiliated Hospital of Beijing University
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The role of routine lymphadenectomy (LND) in the surgical treatment of intrahepatic cholangiocarcinoma (ICC) remains controversial. The investigators' multi-institutional retrospective study have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.
Detailed description
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and its incidence is increasing worldwide.Resection of the primary ICC tumor site within the liver represents the best curative treatment option. However, the role of lymphadenectomy (LND) at the time of surgery remains controversial with some centers considering it standard while other surgeons perform LND only in select circumstances. The utilization of LND may not only vary among different institutions, but also by geographic region. Specifically, data from East and West centers have noted a variation in the utilization of LND ranging 27%-100%.While several case series from Asia have noted that most centers do not regularly perform LND,other data from the West suggest that LND may be becoming more routine. Despite the lack of consensus among surgeons, the American Joint Committee on Cancer (AJCC) Staging manual recommends that the nodal basin be staged. Disease-specific staging for ICC was first introduced in the 7th edition of the AJCC staging manual published in 2010. The newly updated 8th edition of the AJCC staging system now recommends that 6 lymph nodes be evaluated to stage a patient with ICC.
The previous multi-institutional retrospective study from the investigators have showed an increasing adoption of LND among patients undergoing curative resection for ICC during the last decade. The current prospective and randomized study based on a multi-institutional collaboration would investigate whether routine LND would benefit patients in short- and long-term survival remains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- routine hepatoduodenal lymphadenectomy
| Arm | Type | Receives |
|---|---|---|
| lymphadenectomy | Experimental | Procedure: lymphadenectomyThis group of patients would undergo routine hepatoduodenal lymphadenectomy combined with ICC resection |
| No lymphadenectomy | No intervention | –This group of patients would not undergo hepatoduodenal lymphadenectomy when preoperative imaging and intraoperative exploration found no lymph node enlargement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with intrahepatic cholangiocarcinoma by imaging or biopsy
- The tumor is limited in the liver with no distant metastasis, and the primary disease is resectable
- Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found no nodal swelling or enlargement
Key exclusion criteria (5 listed)
- The primary disease is unresectable with or without distant metastasis
- The liver function or general condition of patients does not permit surgery
- Preoperative imaging (e.g. CT, MRI, PET-CT, etc.) and intraoperative exploration found obvious nodal swelling or enlargement, which indicates lymphadenectomy should be performed
- Patients aged below 18 or older than 65 would be excluded
- Pregnant women would not be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphadenectomyPatients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection | Procedure or surgery | lymphadenectomy |
Primary outcome
1-year recurrence rate
Time frame: 1 year after surgery (up to 1 year)
compare the 1-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
3-year recurrence rate
Time frame: 3 years after surgery (up to 3 years)
compare the 3-year recurrence rate of patients undergoing lymphadenectomy and those not undergoing lymphadenectomy
3 secondary outcomes
Postoperative morbidity
Time frame: From the date of surgery to stitches off (up to 1 month)
1-year overall survival
Time frame: 1 year after surgery (up to 1 year)
3-year overall survival
Time frame: 3 years after surgery (up to 3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Lv, MD, PhD study chair
First Affiliated Hospital Xi'an Jiaotong University
Xu-Feng Zhang, MD,PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphadenectomy in people with Intrahepatic Cholangiocarcinoma, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence rate (time frame: 1 year after surgery (up to 1 year)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2021.