Rectal CancerTLTMENCT03359616
Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer
A study testing Transanally curable surgical resection and Laparoscopic total mesorectal excision in people with Rectal Cancer and Surgery, run by Shanghai Minimally Invasive Surgery Center.
Trial summary
Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Surgery
- What is being tested?
- Transanally curable surgical resection and Laparoscopic total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jan 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal adenocarcinoma validated by pathologists, pathological estimated stage II-III;
- Mid and low rectal tumor sites, parameter less than 5cm, below the level of peritoneal reflection and verified by MRI, distance to anus less than 7 cm;
- Curative rectal cancer surgery;
- No evidence of distance metastasis lesions;
- T1-3, N0-2, with or without neoadjuvant therapeutic history;
- Applied to laparoscopic surgery;
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- Absent of previous malignancy-treated history
- No gender restriction, age between 18 and 75, Body Mass Index less than 32;
- Approved by multiple disciplinary teamwork therapeutic group
- Consent by the patient and the family.
Who cannot join
- Mile's surgery is additionally required;
- Tumor invasion is validated on adjacent organs, such as prostate;
- Recurrent rectal cancer, require secondary surgical interventions;
- Previous history of malignant diseases or inflammatory bowel diseases within recent five years;
- Emergent surgery accompanied by bowel obstruction or intestinal perforation;
- Previous history of colorectal surgery, unnatural anatomical structure;
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- Contraindication to general anesthesia (class IV or V in American Society of Anesthesiologists (ASA), or Eastern Cooperative Oncology Group (ECOG) score >=2)
- Pregnant or breast-feeding patients;
- Mental disorder validated by psychiatrists.
- Uncontrolled infectious diseases;
- Participants within other related clinical trials that may influence the conclusion of this trial;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transanal Versus Laparoscopic Total Mesorectal Excision for Mid And Low Rectal Cancer in China (TLTME): a Single-center Randomized Clinical Trial
Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains challenging for classical open and laparoscopic patterns, particularly in male cases. The introduction of transanal total mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low rectal cancer, circumventing the conventional anatomical limits while bringing forward considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is initially established, with the mortality/morbidity and the oncological safety unverified. The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain sparse. Therefore, the features of TaTME, both in short and long terms, await further consolidation by clinical trials. Herein, this single centered, interventional study protocol is established to collect initial clinical data on both the safety and efficacy of the TaTME in comparison with LaTME in East Chinese patients with mid-low rectal cancer.
Read the detailed description
Background: Transanal total mesorectal excision (TaTME) is increasingly accepted as one of the alternative patterns for the resectable rectal cancer worldwide since its first appearance. For mid-low rectal cancer, TaTME features superior viewpoints and direct access to mobilize the primary lesion without the pelvic anatomic limits. Therefore, the matured TaTME technique could deliver satisfactory clinic outcomes in both surgical and oncological senses. However, the studies that designed to compare the feasibility and repeatability of TaTME with conventional laparoscopic total mesorectal excision (LaTME) remain sparse and limited.
Study Objective: Evaluation of short-term mortality and morbidity, long term overall survival and disease-free survival as well as quality of life in rectal cancer patients in East China.
Study Design: This study is a prospective, single-center, randomized clinical trial with a central monitored electronic data processing system. Corresponding randomization, data collection and comparative analysis will be conducted based on the research group discussion. According to the non-inferiority principle, the power is 80% and the α is 0.05 with 10% margin delta (δ). Total patients will be 258, with 129 in each group given 10% lost in follow-up.
Study Endpoints: The primary outcomes measures will be the Disease-free survival (3-years). The secondary outcomes measures will be overall survival (3-years), mesorectal completeness (the quality of the TME specimen, complete, near complete, incomplete), positive circumferential resection margin (CRM), number of retrieved lymph nodes, morbidity rate, mortality rate.
- Conditions
- Rectal Cancer, Surgery
- Being tested
- Transanally curable surgical resection, Laparoscopic total mesorectal excision
- Keywords
- rectal cancer, laparoscopic surgery, total mesorectal excision, transanal surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanally curable surgical resectionProcedure or surgery
Transanally, the rectal cancer will be mobilized with oncological principle of total mesorectal excision
Laparoscopic total mesorectal excisionProcedure or surgery
Conventionally by laparoscopic surgery, the rectal cancer will be mobilized with oncological principle of total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| transanal total mesorectal excision | Experimental | Transanally, the rectum is mobilized through the mesorectal plane according to the TME principles, assisted by the transanal surgical platform (Transanally curable surgical resection). Receives: Procedure: Transanally curable surgical resection |
| laparoscopic total mesorectal excision | Active comparator | By standard laparoscopic techniques, the rectal cancer will be resected by the conventional laparoscopic TME (LaTME). Receives: Procedure: Laparoscopic total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
3-year DFS
Measured: 3-years
Secondary outcomes (6)
Overall survival (OS)
3-years OS
Measured: 3-years
mesorectal completeness
(the quality of the TME specimen, complete, near complete, incomplete)
Measured: 3-years
positive circumferential resection margin
the rate of positive circumferential resection margin (CRM)
Measured: 3-years
number of retrieved lymph nodes
retrieved lymph nodes
Measured: 3-years
morbidity rate
morbidity rate(number of intr-and post-operative encountered cases)
Measured: 3-years
mortality rate
(number of intr-and post-operative encountered complications)
Measured: 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Single blind
- Who is masked
- Participant
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minhua Zheng, M.D., PhD., Study director, MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359616
- Sponsor's protocol ID
- MISC-TaTME
- Acronym
- TLTME
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Motson RW, Whiteford MH, Hompes R, Albert M, Miles WF; Expert Group. Current status of trans-anal total mesorectal excision (TaTME) following the Second International Consensus Conference. Colorectal Dis. 2016 Jan;18(1):13-8. doi: 10.1111/codi.13131.
PubMed 26400670Bulut O, Levic K, Hesselfeldt P, Bulow S. The outcome of rectal cancer after early salvage TME following TEM compared with primary TME: a case-matched study. Tech Coloproctol. 2014 Jan;18(1):83-4. doi: 10.1007/s10151-013-1083-y. Epub 2013 Nov 6. No abstract available.
PubMed 24197900Martin-Perez B, Andrade-Ribeiro GD, Hunter L, Atallah S. A systematic review of transanal minimally invasive surgery (TAMIS) from 2010 to 2013. Tech Coloproctol. 2014 Sep;18(9):775-88. doi: 10.1007/s10151-014-1148-6. Epub 2014 May 7.
PubMed 24848524Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.
PubMed 25185463
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Versus Laparoscopic Total Mesorectal Excision for Mid And Low Rectal Cancer in China (TLTME): a Single-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03359616
- Acronym / sponsor ID
- TLTME / MISC-TaTME
- Conditions
- Rectal Cancer, Surgery
- Keywords
- rectal cancer, laparoscopic surgery, total mesorectal excision, transanal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 2 Dec 2017 (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.
Total mesorectal excision (TME) has been prevailingly accepted as a crucial surgical intervention within the latest oncological therapeutic regime for mid-low rectal cancer. However, surgical dissection under the restricted pelvic anatomical structure, added by obesity and many other general factors, remains challenging for classical open and laparoscopic patterns, particularly in male cases. The introduction of transanal total mesorectal excision (TaTME) offers an optimal pattern for the surgical resection of mid-low rectal cancer, circumventing the conventional anatomical limits while bringing forward considerable advantages by direct dissection. Noteworthy, the surgical techniques of TaTME is initially established, with the mortality/morbidity and the oncological safety unverified. The studies that focus on the comparison between TaTME and laparoscopic TME (LaTME) remain sparse. Therefore, the features of TaTME, both in short and long terms, await further consolidation by clinical trials. Herein, this single centered, interventional study protocol is established to collect initial clinical data on both the safety and efficacy of the TaTME in comparison with LaTME in East Chinese patients with mid-low rectal cancer.
Detailed description
Background: Transanal total mesorectal excision (TaTME) is increasingly accepted as one of the alternative patterns for the resectable rectal cancer worldwide since its first appearance. For mid-low rectal cancer, TaTME features superior viewpoints and direct access to mobilize the primary lesion without the pelvic anatomic limits. Therefore, the matured TaTME technique could deliver satisfactory clinic outcomes in both surgical and oncological senses. However, the studies that designed to compare the feasibility and repeatability of TaTME with conventional laparoscopic total mesorectal excision (LaTME) remain sparse and limited.
Study Objective: Evaluation of short-term mortality and morbidity, long term overall survival and disease-free survival as well as quality of life in rectal cancer patients in East China.
Study Design: This study is a prospective, single-center, randomized clinical trial with a central monitored electronic data processing system. Corresponding randomization, data collection and comparative analysis will be conducted based on the research group discussion. According to the non-inferiority principle, the power is 80% and the α is 0.05 with 10% margin delta (δ). Total patients will be 258, with 129 in each group given 10% lost in follow-up.
Study Endpoints: The primary outcomes measures will be the Disease-free survival (3-years). The secondary outcomes measures will be overall survival (3-years), mesorectal completeness (the quality of the TME specimen, complete, near complete, incomplete), positive circumferential resection margin (CRM), number of retrieved lymph nodes, morbidity rate, mortality rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transanal total mesorectal excision | Experimental | Procedure: Transanally curable surgical resectionTransanally, the rectum is mobilized through the mesorectal plane according to the TME principles, assisted by the transanal surgical platform (Transanally curable surgical resection). |
| laparoscopic total mesorectal excision | Active comparator | Procedure: Laparoscopic total mesorectal excisionBy standard laparoscopic techniques, the rectal cancer will be resected by the conventional laparoscopic TME (LaTME). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Rectal adenocarcinoma validated by pathologists, pathological estimated stage II-III;
- Mid and low rectal tumor sites, parameter less than 5cm, below the level of peritoneal reflection and verified by MRI, distance to anus less than 7 cm;
- Curative rectal cancer surgery;
- No evidence of distance metastasis lesions;
- T1-3, N0-2, with or without neoadjuvant therapeutic history;
Key exclusion criteria (11 listed)
- Mile's surgery is additionally required;
- Tumor invasion is validated on adjacent organs, such as prostate;
- Recurrent rectal cancer, require secondary surgical interventions;
- Previous history of malignant diseases or inflammatory bowel diseases within recent five years;
- Emergent surgery accompanied by bowel obstruction or intestinal perforation;
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 |
|---|---|---|
| Transanally curable surgical resectionTransanally, the rectal cancer will be mobilized with oncological principle of total mesorectal excision | Procedure or surgery | transanal total mesorectal excision |
| Laparoscopic total mesorectal excisionConventionally by laparoscopic surgery, the rectal cancer will be mobilized with oncological principle of total mesorectal excision | Procedure or surgery | laparoscopic total mesorectal excision |
Primary outcome
Disease-free survival (DFS)
Time frame: 3-years
3-year DFS
6 secondary outcomes
Overall survival (OS)
Time frame: 3-years
mesorectal completeness
Time frame: 3-years
positive circumferential resection margin
Time frame: 3-years
number of retrieved lymph nodes
Time frame: 3-years
morbidity rate
Time frame: 3-years
mortality rate
Time frame: 3-years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Background: PubMed 26400670Motson RW, Whiteford MH, Hompes R, Albert M, Miles WF; Expert Group. Current status of trans-anal total mesorectal excision (TaTME) following the Second International Consensus Conference. Colorectal Dis. 2016 Jan;18(1):13-8. doi: 10.1111/codi.13131.
- Background: PubMed 24197900Bulut O, Levic K, Hesselfeldt P, Bulow S. The outcome of rectal cancer after early salvage TME following TEM compared with primary TME: a case-matched study. Tech Coloproctol. 2014 Jan;18(1):83-4. doi: 10.1007/s10151-013-1083-y. Epub 2013 Nov 6. No abstract available.
- Background: PubMed 24848524Martin-Perez B, Andrade-Ribeiro GD, Hunter L, Atallah S. A systematic review of transanal minimally invasive surgery (TAMIS) from 2010 to 2013. Tech Coloproctol. 2014 Sep;18(9):775-88. doi: 10.1007/s10151-014-1148-6. Epub 2014 May 7.
- Results publication: PubMed 25185463Fernandez-Hevia M, Delgado S, Castells A, Tasende M, Momblan D, Diaz del Gobbo G, DeLacy B, Balust J, Lacy AM. Transanal total mesorectal excision in rectal cancer: short-term outcomes in comparison with laparoscopic surgery. Ann Surg. 2015 Feb;261(2):221-7. doi: 10.1097/SLA.0000000000000865.
- 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. This study is not recruiting at the moment.
Minhua Zheng, M.D., PhD. study director
MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
A study testing Transanally curable surgical resection and Laparoscopic total mesorectal excision in people with Rectal Cancer and Surgery, run by Shanghai Minimally Invasive Surgery Center.
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 10 inclusion and 11 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 2 Dec 2017. 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 Minhua Zheng, M.D., PhD. (0086-13564119545, zmhtiger@yeah.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3-years). 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 NCT03359616, which also lists 4 linked publications.
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 2 Dec 2017.