Rectal CancerNCT03724591
Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
A study testing a high ligation of IMA and a low ligation of IMA in people with Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- a high ligation of IMA and a low ligation of IMA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Jan 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suitable for curative surgery over 18 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Pathological diagnosis of rectal adenocarcinoma;
- Patients suitable for abdominalperineal resection
- Informed consent;
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Who cannot join
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation: mechanic ileus, perforation.
Trial locations and contacts
No sites are listed yet.
Fumin Zhang, Professor contact
About this study
Official title: A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer
Read the detailed description
Rectal cancer is one of most frequently diagnosed cancers and one of the leading causes of cancer death around the world. Surgery remains the main treatment for rectal cancer. Anastomosis leakage (AL) is an unresolved, devastating and lethal complication after rectal cancer surgery and remains to be a serious difficulty for surgeons despite its causes, preventions and treatments having been extensively studied.
To achieve a radical dissection of lymph nodes, it is necessary to remove the central lymph nodes at the root of inferior mesenteric artery(IMA) trunk.From the perspectives of lymph nodes dissection and tension-free anastomosis, it is preferred to perform a high ligation of IMA. However, there is still a controversy whether IMA should be high ligated or not. The argument mainly focuses on whether this performance will compromise the blood perfusion of the proximal limb of the anastomosis leading to the occurrence of AL. Some studies suggested that a high ligation did not increase the rate of AL. There are still many surgeons prefer the transection of IMA distal to the left colic artery(LCA) with the intention to preserve a good blood supply of the left colon after the performance of lymph node dissection around IMA. Some studies suggests that the preservation of LCA in anterior resection for mid and low rectal cancer is associated with lower rates of AL. Further investigations are needed to resolve the controversy.
In this study, eligible patients will be randomly allocated to receive total mesorectal excision (TME) for rectal cancer either by a high ligation of IMA without preservation of left colic artery or a low ligation of IMA with preservation of left colic artery. Postoperative complications, including anastomosis leakage, anastomosis bleeding, will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.
- Conditions
- Rectal Cancer
- Being tested
- a high ligation of IMA, a low ligation of IMA
- Keywords
- left colic artery, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a high ligation of IMAProcedure or surgery
total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
a low ligation of IMAProcedure or surgery
total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery
| Study group | Role | What they receive |
|---|---|---|
| a high ligation of IMA | Experimental | total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery Receives: Procedure: a high ligation of IMA |
| a low ligation of IMA | Active comparator | total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery Receives: Procedure: a low ligation of IMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomosis leakage rate
Measured: 30 days
Secondary outcomes (6)
Anastomosis bleeding rate
Measured: 30 days
disease-free survival
Measured: 5 years
local recurrence rate
Measured: 5 years
operative time
Measured: 1 day
number of lymph nodes retrieved
Measured: 1 day
postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQC30 questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueming Sun, PhD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724591
- Sponsor's protocol ID
- CRSYM201810
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2018
- Last updated
- 30 Oct 2018
- 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 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Investigate the Effects of Total Mesorectum Excision With Left Colic Artery Preservation for the Treatment of Rectal Cancer
- ClinicalTrials.gov ID
- NCT03724591
- Acronym / sponsor ID
- CRSYM201810
- Conditions
- Rectal Cancer
- Keywords
- left colic artery, rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 30 Oct 2018 (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.
A randomized controlled clinical trial to compare the short and long term outcomes of left colic artery preservation for the treatment of Rectal Cancer
Detailed description
Rectal cancer is one of most frequently diagnosed cancers and one of the leading causes of cancer death around the world. Surgery remains the main treatment for rectal cancer. Anastomosis leakage (AL) is an unresolved, devastating and lethal complication after rectal cancer surgery and remains to be a serious difficulty for surgeons despite its causes, preventions and treatments having been extensively studied.
To achieve a radical dissection of lymph nodes, it is necessary to remove the central lymph nodes at the root of inferior mesenteric artery(IMA) trunk.From the perspectives of lymph nodes dissection and tension-free anastomosis, it is preferred to perform a high ligation of IMA. However, there is still a controversy whether IMA should be high ligated or not. The argument mainly focuses on whether this performance will compromise the blood perfusion of the proximal limb of the anastomosis leading to the occurrence of AL. Some studies suggested that a high ligation did not increase the rate of AL. There are still many surgeons prefer the transection of IMA distal to the left colic artery(LCA) with the intention to preserve a good blood supply of the left colon after the performance of lymph node dissection around IMA. Some studies suggests that the preservation of LCA in anterior resection for mid and low rectal cancer is associated with lower rates of AL. Further investigations are needed to resolve the controversy.
In this study, eligible patients will be randomly allocated to receive total mesorectal excision (TME) for rectal cancer either by a high ligation of IMA without preservation of left colic artery or a low ligation of IMA with preservation of left colic artery. Postoperative complications, including anastomosis leakage, anastomosis bleeding, will be recorded. Patients will be followed up every 3 months for 2 year, every 6 months for 3 years postoperatively to study the long term effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a high ligation of IMA | Experimental | Procedure: a high ligation of IMAtotal mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery |
| a low ligation of IMA | Active comparator | Procedure: a low ligation of IMAtotal mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients suitable for curative surgery over 18 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Pathological diagnosis of rectal adenocarcinoma;
- Patients suitable for abdominalperineal resection
- Informed consent;
Key exclusion criteria (7 listed)
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show:1. Tumor involves the surrounding organs and combined organ resection need to be done;2. distant metastasis;3. unable to perform R0 resection;
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 |
|---|---|---|
| a high ligation of IMAtotal mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery | Procedure or surgery | a high ligation of IMA |
| a low ligation of IMAtotal mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery | Procedure or surgery | a low ligation of IMA |
Primary outcome
Anastomosis leakage rate
Time frame: 30 days
6 secondary outcomes
Anastomosis bleeding rate
Time frame: 30 days
disease-free survival
Time frame: 5 years
local recurrence rate
Time frame: 5 years
operative time
Time frame: 1 day
number of lymph nodes retrieved
Time frame: 1 day
postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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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.
Fumin Zhang, Professor contact
Yueming Sun, PhD study director
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing a high ligation of IMA and a low ligation of IMA in people with Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueming Sun, PhD (02568306026, jssym@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomosis leakage rate (time frame: 30 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 30 Oct 2018.