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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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 groups in NCT06613399
Study groupRoleWhat they receive
Multi-Technology Integrated Total Mesorectal Excision,MTI-TMEExperimentalNot described
Receives: Procedure: MTI-TME
Conventional Total Mesorectal Excision,C-TMEPlacebo comparatorNot described
Receives: Procedure: C-TME

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. anastomotic leakage rate

    Measured: 1 year

Secondary outcomes (12)
  1. Operation time

    Measured: During surgery

  2. intraoperative blood loss

    Measured: During surgery

  3. 3-year overall suvival rate

    Measured: 3 years

  4. local recurrance rate

    Measured: 3 years

  5. 3-year disease-free survival rate

    Measured: 3 years

  6. 3-year mortality rate

    Measured: 3 years

  7. postoperative quality of life

    Postoperative quality of life will be evaluated by EORTC QLQ C30 Questionnaire

    Measured: 3 years

  8. intestinal exhaust time

    Measured: 1 year

  9. postoperative pain

    Postoperative pain will be assessed by numerical rating scale (NES).

    Measured: 1 year

  10. colostomy rate

    Measured: 1 year

  11. hospital stay

    Measured: 1 year

  12. 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.

  1. First posted26 Sep 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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

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.

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