Rectal CancerNCT02421432
Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases
A study testing Transanal total mesorectal excision in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case. Difficult case is defined as below; If any one of the following (1 or 2 or 3) 1. BMI: 30 or more 2. Tumor size: more than 7cm in long diameter 3. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Transanal total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2017to 1 Dec 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 20-80 years
- biopsy-proven adenocarcinoma of the rectum
- clinical staging (c or yc): T0-3, N0-2, M0
- Rectal cancer located 3-12 cm from the anal verge
- ECOG performance status: 2 or less
- If any one of the following (1 or 2 or 3)
Show all 9Show fewer
- BMI: 30 or more
- Tumor size: more than 7cm in long diameter
- CRM: mesorectal fascia involvement or less than 1 mm on MRI
Who cannot join
- Synchronous colon cancer or other malignancy
- Obstructing rectal cancer
- Pregnant or breast-feeding
- Receiving any other study agents
- Fecal incontinence
- History of prior colorectal cancer or inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case.
Difficult case is defined as below;
- If any one of the following (1 or 2 or 3)
- BMI: 30 or more
- Tumor size: more than 7cm in long diameter
- CRM: mesorectal fascia involvement or less than 1 mm on MRI
Read the detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
- Conditions
- Rectal Cancer
- Being tested
- Transanal total mesorectal excision
- Keywords
- trananal TME, safety, efficacy, difficult cases
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal total mesorectal excisionProcedure or surgery
Laparoscopy-assisted transanal total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Transanal total mesorectal excision | Experimental | Laparoscopy-assisted transanal total mesorectal excision Receives: Procedure: Transanal total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
TME quality & circumferential resection margin (CRM)
The quality of the mesorectum was determined using pathology reports and scored using three grades:
- Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.
- Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.
- Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
Measured: the day of surgery
Secondary outcomes (2)
30-day postoperative complications
The Clavien-Dindo Classification of Surgical Complications. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.
Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III: : Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management.
Grade V: Death of a patient
Measured: 1 month after surgery
Number of harvested Lymph Nodes
Measured: the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start1 Dec 2017
- Primary completion1 Jan 2018
- Study completion1 Dec 2022 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dae Kyung Sohn, National Cancer Center, Korea
- Investigators
- Dae Kyung Sohn, MD, PHD, Principal investigator, Korea: National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421432
- Sponsor's protocol ID
- NCC2015-0050
- Status last verified
- Sep 2021
- First submitted
- 5 Apr 2015
- Last updated
- 10 Sep 2021
- 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 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer
- ClinicalTrials.gov ID
- NCT02421432
- Acronym / sponsor ID
- NCC2015-0050
- Conditions
- Rectal Cancer
- Keywords
- trananal TME, safety, efficacy, difficult cases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- 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.
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case.
Difficult case is defined as below;
- If any one of the following (1 or 2 or 3)
- BMI: 30 or more
- Tumor size: more than 7cm in long diameter
- CRM: mesorectal fascia involvement or less than 1 mm on MRI
Detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transanal total mesorectal excision | Experimental | Procedure: Transanal total mesorectal excisionLaparoscopy-assisted transanal total mesorectal excision |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age: 20-80 years
- biopsy-proven adenocarcinoma of the rectum
- clinical staging (c or yc): T0-3, N0-2, M0
- Rectal cancer located 3-12 cm from the anal verge
- ECOG performance status: 2 or less
Key exclusion criteria (6 listed)
- Synchronous colon cancer or other malignancy
- Obstructing rectal cancer
- Pregnant or breast-feeding
- Receiving any other study agents
- Fecal incontinence
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 |
|---|---|---|
| Transanal total mesorectal excisionLaparoscopy-assisted transanal total mesorectal excision | Procedure or surgery | Transanal total mesorectal excision |
Primary outcome
TME quality & circumferential resection margin (CRM)
Time frame: the day of surgery
The quality of the mesorectum was determined using pathology reports and scored using three grades: * Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. * Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. * Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
2 secondary outcomes
30-day postoperative complications
Time frame: 1 month after surgery
Number of harvested Lymph Nodes
Time frame: the day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
Dae Kyung Sohn, MD, PHD principal investigator
Korea: National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal total mesorectal excision in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 9 inclusion and 6 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 10 Sep 2021. 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 South Korea. 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?
TME quality & circumferential resection margin (CRM) (time frame: the day of 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 10 Sep 2021.