Rectal CancerLATERAL-01NCT03253302
Laparoscopic Assisted Transanal Total Mesorectal Excision for Rectal Cancer in Low Site
An observational study of Rectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lower rectal cancer patients who are suitable and willing to accept laparoscopy- assisted TME procedure and also agree with the trial
Who may be able to join
- adenocarcinoma of the rectum by biopsy
- the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
- tumor diameter less than 4cm
- baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
- tolerable to surgery
- be able to understand and willing to participate in this trial with signature
Who cannot join
- history of malignant colorectal neoplasia
- recent diagnosis with other malignancies
- patients requiring emergency surgery such as obstruction，perforation and bleeding
- tumor involving adjacent organs, anal sphincter, or levator ani muscle
- muti-focal colorectal cancer
- preoperative poor anal function, anal stenosis, anal injury, or fecal incontinence
Show all 13Show fewer
- history of inflammatory bowel disease or familial adenomatous polyposis
- participating in other clinical trails
- can not tolerate the surgery
- history of serious mental illness
- pregnancy or lactating women
- preoperative uncontrolled infection
- the researchers believe the patients should not enrolled in
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Assisted transAnal Total Mesorectal Excision for Rectal cAncer in Low Site :A Prospective,Multi-center, Patients Registry Trial in China (LATERAL Trial)
At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.
- Conditions
- Rectal Cancer
- Keywords
- transanal surgery, total mesorectal excision, rectal cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive rate of circumferential resection margin (CRM) of the specimens
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
Measured: 10 days after surgery
Secondary outcomes (9)
The grade score of the specimens integrity
shows the quality of the specimens: grade 1 is bad gross specimen which means incomplete mesorectum and pelvic fascia, and muscle layer can be see >5mm; grade 3 is high quality gross specimen, which means the specimen is cylindrical, mesorectum and pelvic fascia are complete; grade 2 is between 1and 3.
Measured: 10 days after surgery
The distance between lower tumor margin and the lower reaction margin
shows the oncological safety of the surgery by pathological examination. Reports should contain the distance between lower tumor margin and the lower reaction margin.
Measured: 10 days after surgery
local recurrence rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3 years after surgery
the operative time
preoperative safety containing operation information, complication information.
Measured: 30 days after surgery
postoperative hospital stay
recovery information.
Measured: 3 year after surgery
the score of postoperative life
quality of life contains two scales: Wexner scale and EORTC QLQ-CR29 scale, which show quality of life and the anal function.
Measured: 6 months after surgery
disease free survival rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3-year after surgery
overall survival rate
show the oncological efficacy by 3-year follow-up according to the NCCN guideline. Participants should report every follow-up examinations which prove tumor recurrence and/or metastasis or not.
Measured: 3-year after surgery
the rate of postoperative complications
preoperative safety containing operation information, complication information.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Oct 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2021 (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 Beijing Friendship HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Ruijin Hospital, The First Hospital of Jilin University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Liaoning Cancer Hospital & Institute
- Responsible party
- Principal investigator, Zhongtao Zhang, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253302
- Sponsor's protocol ID
- CR-TaTME
- Acronym
- LATERAL-01
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Assisted transAnal Total Mesorectal Excision for Rectal cAncer in Low Site :A Prospective,Multi-center, Patients Registry Trial in China (LATERAL Trial)
- ClinicalTrials.gov ID
- NCT03253302
- Acronym / sponsor ID
- LATERAL-01 / CR-TaTME
- Conditions
- Rectal Cancer
- Keywords
- transanal surgery, total mesorectal excision, rectal cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, Ruijin Hospital, The First Hospital of Jilin University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Liaoning Cancer Hospital & Institute
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Aug 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.
At present, surgical resection is still the main treatment for the potential cure of rectal cancer. Total mesorectal excision (TME) is the gold standard. The traditional laparoscopic or open surgery for some special patients is really difficult, especially for male, prostate hypertrophy, obesity, low tumor and pelvic stenosis patients to expose the gap around the mesorectum and separate to the pelvic floor. While transanal total mesorectal excision (TaTME) approach could be more directly separate the low mesorectum and relatively simple to complete distal rectal transection, which would bring some considerable advantages. Although active learning from abroad, laparoscopic assisted TaTME surgery is now in its infancy in China. It is urgent for clinical studies to obtain the results in China. This multicenter, observational study will help to encourage research in this field and to obtain data on the safety and efficacy of this procedure in Chinese patients with rectal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lower rectal cancer patients who are suitable and willing to accept laparoscopy- assisted TME procedure and also agree with the trial
Key inclusion criteria (6 listed)
- adenocarcinoma of the rectum by biopsy
- the lower edge of the tumor from the anal margin less than 10cm according to MRI or rigid endoscopy
- tumor diameter less than 4cm
- baseline clinical stage I-III: cT1-3 N0-2 M0 (AJCC v7)
- tolerable to surgery
Key exclusion criteria (13 listed)
- history of malignant colorectal neoplasia
- recent diagnosis with other malignancies
- patients requiring emergency surgery such as obstruction，perforation and bleeding
- tumor involving adjacent organs, anal sphincter, or levator ani muscle
- muti-focal colorectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive rate of circumferential resection margin (CRM) of the specimens
Time frame: 10 days after surgery
Circumferential resection margin (CRM) is the distance between the deepest point of tumor in the primary cancer and the margin of resection in the retroperitoneum or mesentery by pathological examination. CRM 0-1mm is defined as positive, while >1mm is negative.
9 secondary outcomes
The grade score of the specimens integrity
Time frame: 10 days after surgery
The distance between lower tumor margin and the lower reaction margin
Time frame: 10 days after surgery
local recurrence rate
Time frame: 3 years after surgery
the operative time
Time frame: 30 days after surgery
postoperative hospital stay
Time frame: 3 year after surgery
the score of postoperative life
Time frame: 6 months after surgery
disease free survival rate
Time frame: 3-year after surgery
overall survival rate
Time frame: 3-year after surgery
the rate of postoperative complications
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
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 13 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive rate of circumferential resection margin (CRM) of the specimens (time frame: 10 days after surgery). 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 31 Aug 2018.