Colo-rectal CancerNCT06709170
Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
A study testing Novel asymmetrical linear stapler and Signia™ in people with Colo-rectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Novel asymmetrical linear stapler and Signia™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2025to 30 Sep 2025
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal cancer patients between the age of 19~79, who require anus preserving laparoscopic rectum resection surgery
Who cannot join
- Advanced rectal cancer that invades surrounding structures or has known distant metastasis
- Uncontrolled comorbidities
- Patients otherwise considered unsuitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Seung-Bum Ryoo, MD PhD contact
South Korea1 site
Seoul National University Hospital
Seoul, Jongro-gu, 03080
About this study
Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length >1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.
Read the detailed description
Current evidence indicates distal margins of greater than 1cm from the tumor is necessary for superior oncologic outcomes. In middle to lower rectal cancer, where the tumor is close to the anus, sparing the anus whilst securing such a margin may prove difficult.
Failure to secure sufficient margin length may end up in cancer recurrence, but inaccurate assessment of the margin status may also cause further unnecessary resection or failure to spare the anus.
The novel asymmetrical linear stapler was designed specifically with this problem in mind, and one row of stapling was removed from the specimen side to allow easier harvesting of a undisrupted distal margin tissue for pathological evaluation.
This study is a pilot RCT of 30 patients each in the novel stapler group and control group, to prove the non-inferiority in safety and superiority in harvesting the distal margin (assessed by length of margin and time to harvest).
- Conditions
- Colo-rectal Cancer
- Being tested
- Novel asymmetrical linear stapler, Signia™
- Keywords
- Rectal cancer, Frozen sections, Margins of Excision
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel asymmetrical linear staplerDevice
Novel asymmetrical linear stapler
Signia™Device
Signia™
| Study group | Role | What they receive |
|---|---|---|
| Novel asymmetrical linear stapler | Experimental | Rectal cancer patients randomized to this group will use the novel asymmetrical linear stapler for distal rectum transection, and with 2 rows of stapler lines instead of 3, sufficient tissue is left on the specimen side to harvest the true distal margin for accurate pathological evaluation. Receives: Device: Novel asymmetrical linear stapler |
| Control | Active comparator | Rectal cancer patients in the control group will use the conventional Signia™ stapler (Medtronic co.) as routinely used in the centers involved with the study, which has triple stapling technology (3 rows of stapler lines on both sides of transection) Receives: Device: Signia™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
True distal margin length > 1cm
True distal margin: The length of tissue from the distal edge of the specimen to the distal tumor margin in the surgical specimen
Measured: Intraoperative
Secondary outcomes (4)
Early anastomosis leakage
Anastomosis leakage within 30 days of surgery will be documented and reported as an outcome. The International Study Group of Rectal Cancer definition of anastomosis leakage will be used to define the outcome (defect of the intestinal wall at the anastomotic site leading to a communication between the intra- and extraluminal compartments, requiring NPO or other intervention).
Patients that have clinical signs of infection (fever, sepsis, inflammatory lab change or abdominal drain color change) with either fluid collection near the anastomosis or an anastomosis defect on CT imaging will be diagnosed as having anastomosis leakage. CT scans will not be taken routinely, but will be performed when signs of infection (such as abdominal tenderness or high fever) are present.
Severity of the anastomosis leak will be graded according to the International Study Group of Rectal Cancer grading system (grade A, B, C) depending on the necessary intervention (none, non-surgical or surgical).
Measured: From randomization until the date of first documented sign of leakage, assessed up to 30 days
Time to harvest margin
Time (seconds) taken to harvest the distal margin from the specimen for frozen section biopsy
Measured: Intraoperative (from the beginning of frozen section specimen harvest until the acquirement is completed. This process will be timed by a member of the surgical team using a timer.)
Specimen integrity
The pathologist evaluation of whether the whole thickness of bowel was harvested in the distal margin frozen section biopsy. This will be requested and reviewed, reported in the final pathologist report.
Measured: Intraoperative (at the time point of the frozen section pathology report)
Sphincter preservation rate
Although all eligible candidates will be planned for sphincter-preserving surgery, there are some cases where the distal margin is not suffice for an R0 resection and thus receive non-sphincter preserving surgery. The incidence of such non-sphincter preserving surgery (example: abdominoperineal resection) will be reported.
Measured: From randomization until the end of clinical data collection, assessed up to 120 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Mar 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, National Cancer Center, Korea, Kyungpook National University Chilgok Hospital
- Responsible party
- Principal investigator, Ryoo, Seung-Bum, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709170
- Sponsor's protocol ID
- 2023-3198
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of a Novel Asymmetrical Linear Stapler (NALS) for Securing Distal Resection Margin in Laparoscopic Rectal Cancer Surgery: Pilot Study
- ClinicalTrials.gov ID
- NCT06709170
- Acronym / sponsor ID
- 2023-3198
- Conditions
- Colo-rectal Cancer
- Keywords
- Rectal cancer, Frozen sections, Margins of Excision
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Seoul National University Boramae Hospital, National Cancer Center, Korea, Kyungpook National University Chilgok Hospital
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Nov 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.
Through the use of a novel asymmetrical linear stapler (NALS, Meditulip co. Ltd.), we aim to prove that true distal margins greater than 1cm may be harvested more readily and easily compared to the conventional staplers. The study is designed as a pilot RCT of 30 patients in each group, with the primary outcome of distal margin length >1cm. Secondary outcomes include anastomosis dehiscence and time taken to harvest the distal margin.
Detailed description
Current evidence indicates distal margins of greater than 1cm from the tumor is necessary for superior oncologic outcomes. In middle to lower rectal cancer, where the tumor is close to the anus, sparing the anus whilst securing such a margin may prove difficult.
Failure to secure sufficient margin length may end up in cancer recurrence, but inaccurate assessment of the margin status may also cause further unnecessary resection or failure to spare the anus.
The novel asymmetrical linear stapler was designed specifically with this problem in mind, and one row of stapling was removed from the specimen side to allow easier harvesting of a undisrupted distal margin tissue for pathological evaluation.
This study is a pilot RCT of 30 patients each in the novel stapler group and control group, to prove the non-inferiority in safety and superiority in harvesting the distal margin (assessed by length of margin and time to harvest).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel asymmetrical linear stapler | Experimental | Device: Novel asymmetrical linear staplerRectal cancer patients randomized to this group will use the novel asymmetrical linear stapler for distal rectum transection, and with 2 rows of stapler lines instead of 3, sufficient tissue is left on the specimen side to harvest the true distal margin for accurate pathological evaluation. |
| Control | Active comparator | Device: Signia™Rectal cancer patients in the control group will use the conventional Signia™ stapler (Medtronic co.) as routinely used in the centers involved with the study, which has triple stapling technology (3 rows of stapler lines on both sides of transection) |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rectal cancer patients between the age of 19~79, who require anus preserving laparoscopic rectum resection surgery
Key exclusion criteria (3 listed)
- Advanced rectal cancer that invades surrounding structures or has known distant metastasis
- Uncontrolled comorbidities
- Patients otherwise considered unsuitable for the study
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 |
|---|---|---|
| Novel asymmetrical linear staplerNovel asymmetrical linear stapler | Device | Novel asymmetrical linear stapler |
| Signia™Signia™ | Device | Control |
Primary outcome
True distal margin length > 1cm
Time frame: Intraoperative
True distal margin: The length of tissue from the distal edge of the specimen to the distal tumor margin in the surgical specimen
4 secondary outcomes
Early anastomosis leakage
Time frame: From randomization until the date of first documented sign of leakage, assessed up to 30 days
Time to harvest margin
Time frame: Intraoperative (from the beginning of frozen section specimen harvest until the acquirement is completed. This process will be timed by a member of the surgical team using a timer.)
Specimen integrity
Time frame: Intraoperative (at the time point of the frozen section pathology report)
Sphincter preservation rate
Time frame: From randomization until the end of clinical data collection, assessed up to 120 days.
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 29 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Seung-Bum Ryoo, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel asymmetrical linear stapler and Signia™ in people with Colo-rectal Cancer, run by Seoul National University Hospital 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 1 inclusion and 3 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 29 Nov 2024. 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?
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 Jae Hyun Park, MD (+82 10 7233 3820, parkjhyun719@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True distal margin length > 1cm (time frame: Intraoperative). 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 29 Nov 2024.