Colon CancerNCT06865586
A Comparative Study of Tumor Specific Mesocolic Excision and Complete Mesocolic Excision for Right Sided Colon Cancer : Asian Multicenter Retrospective Study
An observational study of Colon Cancer and Lymph Node Dissection, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The goal of this observational study is to determine the optimal surgical strategy based on oncologic outcomes in patients with stage I-III right-sided colon cancer who underwent curative right hemicolectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Lymph Node Dissection, Laparoscopic Colon Surgery
- How many people
- 3,326 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2015to 15 Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study included patients who underwent laparoscopic or robotic right hemicolectomy from 2015 to 2020 at 8 instituions : Asan Medical Center, Korea University Anam Hospital, Severance Hospital, Kyungpook National University Chilgok Hospital, Chinese University of Hong Kong, North District Hospital, Pamela Youde Nethersole Eastern Hospital, and China Medical University Hospital.
Who may be able to join
- Patients who underwent laparoscopic or robotic right hemicolectomy from 2015 to 2020
- Patients who received curative right hemicolectomy with lymphadenectomy
Who cannot join
- Familial adenomatous polyposis (FAP)
- Hereditary non-polyposis colon cancer (HNPCC)
- Patients with inflammatory bowel disease
- Patients with synchronous malignancies in other organs
- Patients with non-adenocarcinoma histology of colon cancer
- Patients with follow-up duration of less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to determine the optimal surgical strategy based on oncologic outcomes in patients with stage I-III right-sided colon cancer who underwent curative right hemicolectomy.
The main question it aims to answer is: Is there a significant difference in 5-year recurrence-free survival (RFS) between patients treated with Complete Mesocolic Excision (CME) and those treated with tumor specific mesocolic excision (TSME)? Participants will include patients who underwent curative right hemicolectomy for right-sided colon cancer between 2015 and 2020 at eight institutions. They will be categorized into two groups based on the surgical technique received-CME group and TSME group-and evaluated for primary and secondary endpoints of 5-year recurrence-free survival (RFS) and overall survival (OS), respectively.
Read the detailed description
This observational, population-based cohort study was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, with approval obtained from the institutional review board (IRB) of the primary institution and the ethics committees of each participating institution in the Republic of Korea, Hong Kong, and Taiwan. Given that the study utilized anonymized retrospective data, the requirement for informed consent was waived.
The study aimed to evaluate the efficacy and safety of Tumor Specific Mesocolic Excision (TSME) compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. Patients diagnosed with right-sided colon cancer who underwent laparoscopic or robotic right hemicolectomy between 2015 and 2020 were included. Surgical techniques were classified into modified TSME or CME, and the study assessed oncologic outcomes, including recurrence-free survival (RFS), overall survival (OS), lymph node yield, and stage distribution.
Data collection was conducted at multiple medical centers across Asia to ensure a diverse representation of patient demographics and clinical practices. The participating institutions included Asan Medical Center, Korea University Anam Hospital, Severance Hospital, Kyungpook National University Chilgok Hospital, Chinese University of Hong Kong, North District Hospital, Pamela Youde Nethersole Eastern Hospital, and China Medical University Hospital. These centers, varying in location and size, enhance the study's generalizability within the context of right-sided colon cancer management in Asia.
- Conditions
- Colon Cancer, Lymph Node Dissection, Laparoscopic Colon Surgery, Robotic Surgical Procedure
- Keywords
- colon cancer, right hemicolectomy, complete mesocolic excision, lymph node dissection, microinvasive surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent laparoscopic or robotic right hemicolectomy with CME from 2015 to 2020 | Patients who underwent laparoscopic or robotic right hemicolectomy with Complete mesocolic excision from 2015 to 2020 in 8 centers | |
| Patients who underwent with tumor specific mesocolic exicision from 2015 to 2020 | Patients who underwent laparoscopic or robotic right hemicolectomy with tumor specific mesocolic exicision from 2015 to 2020 in 8 centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year Recurrence free survival
Recurrence-Free Survival (RFS) between patients who underwent TSME and CME procedures from 2015 to 2020
Measured: Outcome measures will be assessed at 5 years post-surgery.
Secondary outcomes (1)
Overall survival
Overall survival (OS) between patients who underwent TSME and CME procedures form 2015 to 2020
Measured: Outcome measures will be assessed at 5 years post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2020
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital, Kyungpook National University Chilgok Hospital, Severance Hospital, Chinese University of Hong Kong, Pamela Youde Nethersole Eastern Hospital, North District Hospital, China Medical University Hospital
- Responsible party
- Principal investigator, In Ja Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865586
- Sponsor's protocol ID
- SMART core
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 10 Mar 2025
- 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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Tumor Specific Mesocolic Excision and Complete Mesocolic Excision for Right Sided Colon Cancer : Asian Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06865586
- Acronym / sponsor ID
- SMART core
- Conditions
- Colon Cancer, Lymph Node Dissection, Laparoscopic Colon Surgery, Robotic Surgical Procedure
- Keywords
- colon cancer, right hemicolectomy, complete mesocolic excision, lymph node dissection, microinvasive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,326 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital, Kyungpook National University Chilgok Hospital, Severance Hospital, Chinese University of Hong Kong, Pamela Youde Nethersole Eastern Hospital, North District Hospital, China Medical University Hospital
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 10 Mar 2025 (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.
The goal of this observational study is to determine the optimal surgical strategy based on oncologic outcomes in patients with stage I-III right-sided colon cancer who underwent curative right hemicolectomy.
The main question it aims to answer is: Is there a significant difference in 5-year recurrence-free survival (RFS) between patients treated with Complete Mesocolic Excision (CME) and those treated with tumor specific mesocolic excision (TSME)? Participants will include patients who underwent curative right hemicolectomy for right-sided colon cancer between 2015 and 2020 at eight institutions. They will be categorized into two groups based on the surgical technique received-CME group and TSME group-and evaluated for primary and secondary endpoints of 5-year recurrence-free survival (RFS) and overall survival (OS), respectively.
Detailed description
This observational, population-based cohort study was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, with approval obtained from the institutional review board (IRB) of the primary institution and the ethics committees of each participating institution in the Republic of Korea, Hong Kong, and Taiwan. Given that the study utilized anonymized retrospective data, the requirement for informed consent was waived.
The study aimed to evaluate the efficacy and safety of Tumor Specific Mesocolic Excision (TSME) compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. Patients diagnosed with right-sided colon cancer who underwent laparoscopic or robotic right hemicolectomy between 2015 and 2020 were included. Surgical techniques were classified into modified TSME or CME, and the study assessed oncologic outcomes, including recurrence-free survival (RFS), overall survival (OS), lymph node yield, and stage distribution.
Data collection was conducted at multiple medical centers across Asia to ensure a diverse representation of patient demographics and clinical practices. The participating institutions included Asan Medical Center, Korea University Anam Hospital, Severance Hospital, Kyungpook National University Chilgok Hospital, Chinese University of Hong Kong, North District Hospital, Pamela Youde Nethersole Eastern Hospital, and China Medical University Hospital. These centers, varying in location and size, enhance the study's generalizability within the context of right-sided colon cancer management in Asia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent laparoscopic or robotic right hemicolectomy with CME from 2015 to 2020 | – | –Patients who underwent laparoscopic or robotic right hemicolectomy with Complete mesocolic excision from 2015 to 2020 in 8 centers |
| Patients who underwent with tumor specific mesocolic exicision from 2015 to 2020 | – | –Patients who underwent laparoscopic or robotic right hemicolectomy with tumor specific mesocolic exicision from 2015 to 2020 in 8 centers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study included patients who underwent laparoscopic or robotic right hemicolectomy from 2015 to 2020 at 8 instituions : Asan Medical Center, Korea University Anam Hospital, Severance Hospital, Kyungpook National University Chilgok Hospital, Chinese University of Hong Kong, North District Hospital, Pamela Youde Nethersole Eastern Hospital, and China Medical University Hospital.
Key inclusion criteria (2 listed)
- Patients who underwent laparoscopic or robotic right hemicolectomy from 2015 to 2020
- Patients who received curative right hemicolectomy with lymphadenectomy
Key exclusion criteria (6 listed)
- Familial adenomatous polyposis (FAP)
- Hereditary non-polyposis colon cancer (HNPCC)
- Patients with inflammatory bowel disease
- Patients with synchronous malignancies in other organs
- Patients with non-adenocarcinoma histology of colon 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
5 year Recurrence free survival
Time frame: Outcome measures will be assessed at 5 years post-surgery.
Recurrence-Free Survival (RFS) between patients who underwent TSME and CME procedures from 2015 to 2020
1 secondary outcome
Overall survival
Time frame: Outcome measures will be assessed at 5 years post-surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- 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. 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 Colon Cancer and Lymph Node Dissection, run by Asan Medical Center 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 2 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: finished, as of the sponsor's last update on 10 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
5 year Recurrence free survival (time frame: Outcome measures will be assessed at 5 years post-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 Mar 2025.