Rectal CancerNCT05807646
Reduced Dissemination of Tumor Cells With Primary Ligation of the Inferior Mesenteric Vein in Rectal Cancer Patients.
A study testing Vein ligation first and Artery ligation first in people with Rectal Cancer, run by Sichuan Cancer Hospital and Research Institute.
Trial summary
Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery: a prospective, multicenter, randomized controlled study (ARVECTS) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Vein ligation first and Artery ligation first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 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
- Age: 18-75 years;
- Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm from the anal verge at colonoscopy);
- Patients with a stage I-III rectal cancer eligible for surgery and R0 resection is expected, patients with pelvic lateral lymph nodes metastasis are ineligible;
- ECOG score: 0-1;
- ASA score: I/II/III;
- Laparoscopic surgery;
- Informed consent.
Who cannot join
- Patients who have received preoperative treatment (such as preoperative radiotherapy and chemotherapy);
- Receiving transanal total mesorectal excision (taTME), specimen extraction through natural lumen (NOSES) ;
- Recurrent rectal cancer;
- Simultaneous or metachronous colorectal cancer;
- Malignant tumors of other organs in the past 5 years or at the same time;
- The results of preoperative physical examination and imaging examination showed that: (1) the tumor involved the surrounding organs and required combined organ resection; (2) distant metastasis; (3) could not be resected at R0;
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- Pregnant or lactating women;
- Patients with severe mental disorder;
- It is not suitable for patients undergoing laparoscopic surgery (such as extensive adhesion caused by previous abdominal surgery or inability to tolerate artificial pneumoperitoneum);
- History of unstable angina pectoris or myocardial infarction in the past 6 months;
- Have a history of cerebrovascular accident in the past 6 months;
- Systemic administration of corticosteroids within 1 month before enrollment;
- Taking folic acid related drugs within half a year before operation.
- Severe cardiac insufficiency (FEV1<50% of predicted values);
- Emergency surgery.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ligation Sequence of the Inferior Mesenteric Artery and Vein on Circulating Tumor Cells and Survival in Laparoscopic Rectal Cancer Surgery: a Prospective, Multicenter, Randomized Controlled Study (ARVECTS)
Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery: a prospective, multicenter, randomized controlled study (ARVECTS)
Read the detailed description
Several studies have demonstrated that the presence of circulating tumor cells (CTCs) in the peripheral blood can be a surrogate biomarker to predict recurrence and prognosis of rectal cancer. CTCs are released from the primary tumor into the bloodstream and have the potential to spread to distant sites and develop into micro-metastatic deposits. Numerous studies have demonstrated that surgical manipulation could promote the dissemination of tumor cells into the circulation. Theoretically, the potential risk of tumor cell dissemination can theoretically be minimized if the effluent vein was ligated first. However, there is no regulation in the current guidelines on the sequence of ligation of the inferior mesenteric artery and vein during rectal cancer surgery owing to a lack of sufficient evidence. This multi-center randomized controlled trial is to investigate effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery
- Conditions
- Rectal Cancer
- Being tested
- Vein ligation first, Artery ligation first
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein ligation firstOther
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first.
Artery ligation firstOther
During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first.
| Study group | Role | What they receive |
|---|---|---|
| Vein ligation first | Experimental | During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first. Receives: Other: Vein ligation first |
| Artery ligation first | Active comparator | During this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first. Receives: Other: Artery ligation first |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of the level of circulating tumor cells in the peripheral blood
The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the abdomen
Measured: During the surgery
Secondary outcomes (10)
3-year disease-free survival
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
Measured: From date of surgery, assessed up to 36 months
3-years overall survival
The proportion of patients who survived 3 years after surgery
Measured: From date of surgery, assessed up to 36 months
Recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Measured: From date of surgery, assessed up to 36 months
Blood loss
Blood loss during the surgery
Measured: During the surgery
Operation time
Operation time
Measured: During the surgery
Conversive rate
Conversive rate
Measured: During the surgery
Number of lymph nodes collected
Number of lymph nodes collected
Measured: During the surgery
Intraoperative morbidity and mortality rates
The intraoperative morbidity rates are defined as the rates of event observed within operation
Measured: During the surgery
Postoperative morbidity and motality rates
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery
Measured: 30 days
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Provincial People's Hospital, The Second People's Hospital of Chengdu
- Responsible party
- Principal investigator, Tao Pan, Sichuan Cancer Hospital and Research Institute
- Investigators
- Chao Liu, Professor, Study director, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807646
- Sponsor's protocol ID
- SichuanCHRI123
- Status last verified
- Feb 2024
- First submitted
- 29 Mar 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan T, Hu H, Liu C, Zhou HY. Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumour cells and survival in minimally invasive rectal cancer surgery: study protocol for a randomised controlled trial (ARVECTS study). BMJ Open. 2025 Nov 19;15(11):e098428. doi: 10.1136/bmjopen-2024-098428.
PubMed 41263842
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ligation Sequence of the Inferior Mesenteric Artery and Vein on Circulating Tumor Cells and Survival in Laparoscopic Rectal Cancer Surgery: a Prospective, Multicenter, Randomized Controlled Study (ARVECTS)
- ClinicalTrials.gov ID
- NCT05807646
- Acronym / sponsor ID
- SichuanCHRI123
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Collaborators
- Sichuan Provincial People's Hospital, The Second People's Hospital of Chengdu
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Apr 2023 (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.
Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery: a prospective, multicenter, randomized controlled study (ARVECTS)
Detailed description
Several studies have demonstrated that the presence of circulating tumor cells (CTCs) in the peripheral blood can be a surrogate biomarker to predict recurrence and prognosis of rectal cancer. CTCs are released from the primary tumor into the bloodstream and have the potential to spread to distant sites and develop into micro-metastatic deposits. Numerous studies have demonstrated that surgical manipulation could promote the dissemination of tumor cells into the circulation. Theoretically, the potential risk of tumor cell dissemination can theoretically be minimized if the effluent vein was ligated first. However, there is no regulation in the current guidelines on the sequence of ligation of the inferior mesenteric artery and vein during rectal cancer surgery owing to a lack of sufficient evidence. This multi-center randomized controlled trial is to investigate effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumor cells and survival in laparoscopic rectal cancer surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vein ligation first | Experimental | Other: Vein ligation firstDuring this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first. |
| Artery ligation first | Active comparator | Other: Artery ligation firstDuring this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18-75 years;
- Histopathologically confirmed as rectal adenocarcinoma(tumor located within 15 cm from the anal verge at colonoscopy);
- Patients with a stage I-III rectal cancer eligible for surgery and R0 resection is expected, patients with pelvic lateral lymph nodes metastasis are ineligible;
- ECOG score: 0-1;
- ASA score: I/II/III;
Key exclusion criteria (15 listed)
- Patients who have received preoperative treatment (such as preoperative radiotherapy and chemotherapy);
- Receiving transanal total mesorectal excision (taTME), specimen extraction through natural lumen (NOSES) ;
- Recurrent rectal cancer;
- Simultaneous or metachronous colorectal cancer;
- Malignant tumors of other organs in the past 5 years or at the same time;
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 |
|---|---|---|
| Vein ligation firstDuring this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric vein ligated first. | Other | Vein ligation first |
| Artery ligation firstDuring this procedure, patients undergo laparoscopic rectal cancer surgery with the inferior mesenteric artery ligated first. | Other | Artery ligation first |
Primary outcome
The changes of the level of circulating tumor cells in the peripheral blood
Time frame: During the surgery
The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the abdomen
10 secondary outcomes
3-year disease-free survival
Time frame: From date of surgery, assessed up to 36 months
3-years overall survival
Time frame: From date of surgery, assessed up to 36 months
Recurrence pattern
Time frame: From date of surgery, assessed up to 36 months
Blood loss
Time frame: During the surgery
Operation time
Time frame: During the surgery
Conversive rate
Time frame: During the surgery
Number of lymph nodes collected
Time frame: During the surgery
Intraoperative morbidity and mortality rates
Time frame: During the surgery
Postoperative morbidity and motality rates
Time frame: 30 days
Postoperative recovery course
Time frame: 10 days
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 15 Feb 2024.
- Derived from this study: PubMed 41263842Pan T, Hu H, Liu C, Zhou HY. Effect of ligation sequence of the inferior mesenteric artery and vein on circulating tumour cells and survival in minimally invasive rectal cancer surgery: study protocol for a randomised controlled trial (ARVECTS study). BMJ Open. 2025 Nov 19;15(11):e098428. doi: 10.1136/bmjopen-2024-098428.
- Individual participant dataSharing planned: No
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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.
Chao Liu, Professor study director
Sichuan Cancer Hospital and Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Vein ligation first and Artery ligation first in people with Rectal Cancer, run by Sichuan Cancer Hospital and Research Institute.
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 15 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: opening soon, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Tao Pan, Doctor (+86-18181986821, taopancd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of the level of circulating tumor cells in the peripheral blood (time frame: During the 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 NCT05807646, which also lists 1 linked publication.
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 15 Feb 2024.