Rectal Neuroendocrine NeoplasmNCT06279299
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
A study testing lateral pelvic lymph node dissection in people with Rectal Neuroendocrine Neoplasm, run by National Cancer Center, China at 1 site in China.
Trial summary
The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neuroendocrine Neoplasm
- What is being tested?
- lateral pelvic lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Aug 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
- Meets any one of the following conditions:
- Preoperative imaging examinations reveal that the maximum diameter of the tumor is greater than 2cm.
- Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and the clinical staging is T2 or higher.
- Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and is categorized as Grade 3 differentiation.
- Recurrence after local excision under endoscopy.
- Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
- Written informed consent;
Who cannot join
- Complete intestinal obstruction;
- Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
- Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation；
- Pregnancy or breastfeeding;
- Alcohol abuse or drug addiction;
- Concurrent uncontrolled medical condition;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center
Beijing, Beijing Municipality, 100000
Haitao Zhou, M.D., +8613381167333, zhouhaitao01745@163.com
Yueyang Zhang, M.D., +8613552910035, yyzhang0129@163.com
About this study
The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.
Read the detailed description
This study is a prospective single-arm clinical study. 30 patients with rNENs undergoing TME are planned to be included in the study. The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in (rNENs) undergoing laparoscopic TME. The primary endpoint is the rate of lateral pelvic lymph nodes metastasis. The primary hypothesis was the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.
This study seeks to report for the first time the true status of lateral pelvic lymph node metastasis in these patients. In addition, the proportion of patients with radical resection (R0), surgical complication profile, and quality of life (QoL) are also secondary endpoints.
- Conditions
- Rectal Neuroendocrine Neoplasm
- Being tested
- lateral pelvic lymph node dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral pelvic lymph node dissectionProcedure or surgery
Following the total mesorectal excision principle, the rectum and mesentery are removed, with careful protection of the pelvic autonomic nerves. After completing laparoscopic rectal resection, lateral lymph node dissection is performed. The lateral dissection follows these steps: ① Open the peritoneum at the bifurcation of the iliac vessels, dissect along the retroperitoneum adjacent to the ureter-bladder fascia, expose the lateral pelvic area, and carefully protect the ureter and hypogastric nerves. Open the peritoneum along the edge of the external iliac vessels close to the inguinal ligament, clear the lymphatic fatty tissue alongside the external iliac vessels along the edge of the iliopsoas and internal oblique muscles; ② After identifying the hypogastric nerve, dissect along the bladder-bladder fascia, separate the bladder and the fat tissue around the lateral pelvic space, completely remove the lymphatic tissue around the internal iliac vessels and hypogastric nerves.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Pelvic lymph node dissection | Experimental | After performing TME surgery, further conduct lateral pelvic lymph nodes dissection. Receives: Procedure: lateral pelvic lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of lateral pelvic lymph node metastasis
The rate of lateral pelvic lymph node metastasis = lateral pelvic lymph node metastasis cases/all cases.
Measured: up to 14 days
Secondary outcomes (5)
The rate of lymph node metastasis
The rate of lymph node metastasis = lymph node metastasis cases/all cases.
Measured: up to 14 days
Disease-free survival rate
Disease-free survival (DFS) is a number that tells the chances of staying free of a disease or cancer after a particular treatment. It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.
Measured: three years
Overall survival rate
The time from diagnosis to (for any reason) death.
Measured: three years
Locoregional recurrence free survival rate
Locoregional Recurrence Free Survival is defined as the time interval between the day of diagnosis in the study and the date of local relapse/recurrence or regional relapse/recurrence whichever occurs first.
Measured: three year
Radical resection (R0)
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy
Measured: up to 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Aug 2022
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitao Zhou, National Cancer Center, China
- Investigators
- Haitao Zhou, Study chair, National Cancer Center, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279299
- Sponsor's protocol ID
- LLND
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
- ClinicalTrials.gov ID
- NCT06279299
- Acronym / sponsor ID
- LLND
- Conditions
- Rectal Neuroendocrine Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cancer Center, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 28 Feb 2024 (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 purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.
Detailed description
This study is a prospective single-arm clinical study. 30 patients with rNENs undergoing TME are planned to be included in the study. The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in (rNENs) undergoing laparoscopic TME. The primary endpoint is the rate of lateral pelvic lymph nodes metastasis. The primary hypothesis was the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.
This study seeks to report for the first time the true status of lateral pelvic lymph node metastasis in these patients. In addition, the proportion of patients with radical resection (R0), surgical complication profile, and quality of life (QoL) are also secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lateral Pelvic lymph node dissection | Experimental | Procedure: lateral pelvic lymph node dissectionAfter performing TME surgery, further conduct lateral pelvic lymph nodes dissection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
- Meets any one of the following conditions:
- Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
- Written informed consent;
Key exclusion criteria (6 listed)
- Complete intestinal obstruction;
- Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
- Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation；
- Pregnancy or breastfeeding;
- Alcohol abuse or drug addiction;
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 |
|---|---|---|
| lateral pelvic lymph node dissectionFollowing the total mesorectal excision principle, the rectum and mesentery are removed, with careful protection of the pelvic autonomic nerves. After completing laparoscopic rectal resection, lateral lymph node dissection is performed. The lateral dissection follows these steps: ① Open the peritoneum at the bifurcation of the iliac vessels, dissect along the retroperitoneum adjacent to the ureter-bladder fascia, expose the lateral pelvic area, and carefully protect the ureter and hypogastric nerves. Open the peritoneum along the edge of the external iliac vessels close to the inguinal ligament, clear the lymphatic fatty tissue alongside the external iliac vessels along the edge of the iliopsoas and internal oblique muscles; ② After identifying the hypogastric nerve, dissect along the bladder-bladder fascia, separate the bladder and the fat tissue around the lateral pelvic space, completely remove the lymphatic tissue around the internal iliac vessels and hypogastric nerves. | Procedure or surgery | Lateral Pelvic lymph node dissection |
Primary outcome
The rate of lateral pelvic lymph node metastasis
Time frame: up to 14 days
The rate of lateral pelvic lymph node metastasis = lateral pelvic lymph node metastasis cases/all cases.
5 secondary outcomes
The rate of lymph node metastasis
Time frame: up to 14 days
Disease-free survival rate
Time frame: three years
Overall survival rate
Time frame: three years
Locoregional recurrence free survival rate
Time frame: three year
Radical resection (R0)
Time frame: up to 14 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No. Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
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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.
Haitao Zhou study chair
National Cancer Center, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral pelvic lymph node dissection in people with Rectal Neuroendocrine Neoplasm, run by National Cancer Center, China 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 8 inclusion and 6 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 28 Feb 2024. 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?
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 Yueyang Zhang, M.D. (+8613552910035, yyzhang0129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of lateral pelvic lymph node metastasis (time frame: up to 14 days). 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 28 Feb 2024.