Rectal CancerNCT06613399
Multi-Technology Integrated Total Mesorectal Excision Versus Conventional Total Mesorectal Excision for the Treatment of Middle and Distal Rectal Cancer.
A study testing MTI-TME and C-TME in people with Rectal Cancer, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
A multicenter, prospective, randomized, controlled clinical trial of multi-technology integration total mesorectal excision (MTI-TME) versus conventional total mesorectal excision (C-TME) for the treatment of middle and distal rectal cancer 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?
- MTI-TME and C-TME
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be aged 18 to 75.
- Histopathological examination of the preoperative biopsy confirms adenocarcinoma.
- Preoperative MRI shows the tumor\'s lower margin is below the umbilical ligament.
- High-resolution CT and MRI do not indicate suspicious distant metastasis.
- Participants\' general condition is acceptable, with an ASA score of ≤3 before surgery.
- Participants must sign an informed consent form.
Who cannot join
- Developing other malignant tumors within 5 years;
- Multiple primary colorectal tumors;
- Pregnant or lactating women;
- Patients with severe mental disorders;
- Severe intestinal diseases;
- Poor general condition and uncontrolled comorbidities;
- Ineligible for laparoscopic surgery;
- Participating in other clinical trials.
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: A Randomized Controlled Study of Multi-technology Integration Total Mesorectal Excision (MTI-TME) Versus Conventional Total Mesorectal Excision (C-TME) for the Treatment of Middle and Distal Rectal Cancer.
A multicenter, prospective, randomized, controlled clinical trial of multi-technology integration total mesorectal excision (MTI-TME) versus conventional total mesorectal excision (C-TME) for the treatment of middle and distal rectal cancer
Read the detailed description
Currently, laparoscopic total mesorectal excision (TME) has become the standard procedure for treating middle and distal rectal cancer. Anastomotic leakage has always been one of the serious complications of TME surgery, and Anastomotic leakage not only increases the hospital expenses, but also brings physical discomfort and psychological pain to the patients. Furthermore, anastomotic leakage is associated with a heightened risk of anastomotic stenosis, compromised bowel function, delayed initiation of postoperative adjuvant therapy, increased local recurrence rates post-surgery, and diminished long-term survival outcomes. A report from the Netherlands indicates that anastomotic leakage serves as an independent prognostic factor for overall survival in patients diagnosed with rectal cancer. Prior studies have documented the incidence of anastomotic leakage to range between 3.6% and 21%, attributable to a confluence of various factors including technical complications, oncological considerations, and the patient\'s overall health status. Among these determinants, aspects such as blood supply adequacy, tension at the site of anastomosis, tissue quality, and anatomical positioning of the rectum are widely recognized as significant risk factors for developing anastomotic leaks.Currently, several strategies are employed to mitigate the incidence of anastomotic leakage, including preoperative proctocolectomy, anal decompression placement, vertical transverse resection of the rectum, and anastomotic reinforcement techniques. In our clinical practice, we have innovatively integrated multiple approaches: (1) preservation of the left colic artery (LCA); (2) high-level resection of the inferior mesenteric vein (IMV); (3) standardized mobilization of the splenic flexure along with left lateral colon; (4) multi-plane dissection of mesorectal flaps; and (5) selective reinforcement at the anastomosis. Our findings indicate that multi-technology integrated total mesorectal excision (MTI-TME) significantly reduces both preventive stoma rates and incidences of anastomotic leakage compared to conventional total mesorectal excision (C-TME), . However, there remains a lack of robust evidence-based medicine supporting MTI-TME\'s advantages in treating middle and distal rectal cancer; further research is urgently needed to provide additional clinical evidence.
- Conditions
- Rectal Cancer
- Being tested
- MTI-TME, C-TME
- Keywords
- MTI-TME, anastomotic leakage
- Medical subject headings
- Rectal Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTI-TMEProcedure or surgery
Multi-Technology Tntegrated Total Mesorectal Excision,MTI-TME
C-TMEProcedure or surgery
Conventional Total Mesorectal Excision,C-TME
| Study group | Role | What they receive |
|---|---|---|
| Multi-Technology Integrated Total Mesorectal Excision,MTI-TME | Experimental | Not described Receives: Procedure: MTI-TME |
| Conventional Total Mesorectal Excision,C-TME | Placebo comparator | Not described Receives: Procedure: C-TME |
What is being measured
The primary outcome is the main question the study is designed to answer.
anastomotic leakage rate
Measured: 1 year
Secondary outcomes (12)
Operation time
Measured: During surgery
intraoperative blood loss
Measured: During surgery
3-year overall suvival rate
Measured: 3 years
local recurrance rate
Measured: 3 years
3-year disease-free survival rate
Measured: 3 years
3-year mortality rate
Measured: 3 years
postoperative quality of life
Postoperative quality of life will be evaluated by EORTC QLQ C30 Questionnaire
Measured: 3 years
intestinal exhaust time
Measured: 1 year
postoperative pain
Postoperative pain will be assessed by numerical rating scale (NES).
Measured: 1 year
colostomy rate
Measured: 1 year
hospital stay
Measured: 1 year
hospital cost
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Dec 2027 (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.
- 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
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613399
- Sponsor's protocol ID
- PRSYM202409
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Multi-technology Integration Total Mesorectal Excision (MTI-TME) Versus Conventional Total Mesorectal Excision (C-TME) for the Treatment of Middle and Distal Rectal Cancer.
- ClinicalTrials.gov ID
- NCT06613399
- Acronym / sponsor ID
- PRSYM202409
- Conditions
- Rectal Cancer
- Keywords
- MTI-TME, anastomotic leakage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Sep 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.
A multicenter, prospective, randomized, controlled clinical trial of multi-technology integration total mesorectal excision (MTI-TME) versus conventional total mesorectal excision (C-TME) for the treatment of middle and distal rectal cancer
Detailed description
Currently, laparoscopic total mesorectal excision (TME) has become the standard procedure for treating middle and distal rectal cancer. Anastomotic leakage has always been one of the serious complications of TME surgery, and Anastomotic leakage not only increases the hospital expenses, but also brings physical discomfort and psychological pain to the patients. Furthermore, anastomotic leakage is associated with a heightened risk of anastomotic stenosis, compromised bowel function, delayed initiation of postoperative adjuvant therapy, increased local recurrence rates post-surgery, and diminished long-term survival outcomes. A report from the Netherlands indicates that anastomotic leakage serves as an independent prognostic factor for overall survival in patients diagnosed with rectal cancer. Prior studies have documented the incidence of anastomotic leakage to range between 3.6% and 21%, attributable to a confluence of various factors including technical complications, oncological considerations, and the patient\'s overall health status. Among these determinants, aspects such as blood supply adequacy, tension at the site of anastomosis, tissue quality, and anatomical positioning of the rectum are widely recognized as significant risk factors for developing anastomotic leaks.Currently, several strategies are employed to mitigate the incidence of anastomotic leakage, including preoperative proctocolectomy, anal decompression placement, vertical transverse resection of the rectum, and anastomotic reinforcement techniques. In our clinical practice, we have innovatively integrated multiple approaches: (1) preservation of the left colic artery (LCA); (2) high-level resection of the inferior mesenteric vein (IMV); (3) standardized mobilization of the splenic flexure along with left lateral colon; (4) multi-plane dissection of mesorectal flaps; and (5) selective reinforcement at the anastomosis. Our findings indicate that multi-technology integrated total mesorectal excision (MTI-TME) significantly reduces both preventive stoma rates and incidences of anastomotic leakage compared to conventional total mesorectal excision (C-TME), . However, there remains a lack of robust evidence-based medicine supporting MTI-TME\'s advantages in treating middle and distal rectal cancer; further research is urgently needed to provide additional clinical evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Technology Integrated Total Mesorectal Excision,MTI-TME | Experimental | Procedure: MTI-TME |
| Conventional Total Mesorectal Excision,C-TME | Placebo comparator | Procedure: C-TME |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be aged 18 to 75.
- Histopathological examination of the preoperative biopsy confirms adenocarcinoma.
- Preoperative MRI shows the tumor\'s lower margin is below the umbilical ligament.
- High-resolution CT and MRI do not indicate suspicious distant metastasis.
- Participants\' general condition is acceptable, with an ASA score of ≤3 before surgery.
Key exclusion criteria (8 listed)
- Developing other malignant tumors within 5 years;
- Multiple primary colorectal tumors;
- Pregnant or lactating women;
- Patients with severe mental disorders;
- Severe intestinal diseases;
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 |
|---|---|---|
| MTI-TMEMulti-Technology Tntegrated Total Mesorectal Excision,MTI-TME | Procedure or surgery | Multi-Technology Integrated Total Mesorectal Excision,MTI-TME |
| C-TMEConventional Total Mesorectal Excision,C-TME | Procedure or surgery | Conventional Total Mesorectal Excision,C-TME |
Primary outcome
anastomotic leakage rate
Time frame: 1 year
12 secondary outcomes
Operation time
Time frame: During surgery
intraoperative blood loss
Time frame: During surgery
3-year overall suvival rate
Time frame: 3 years
local recurrance rate
Time frame: 3 years
3-year disease-free survival rate
Time frame: 3 years
3-year mortality rate
Time frame: 3 years
postoperative quality of life
Time frame: 3 years
intestinal exhaust time
Time frame: 1 year
postoperative pain
Time frame: 1 year
colostomy rate
Time frame: 1 year
hospital stay
Time frame: 1 year
hospital cost
Time frame: 1 year
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 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing MTI-TME and C-TME 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 8 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 26 Sep 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. Some participants in this study may receive a placebo. 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 Yueming Sun, MD (86-025-68306026, sunyueming@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anastomotic leakage rate (time frame: 1 year). 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 26 Sep 2024.