Colon CancerNCT04980287
Mesogastrium Metastasis in Colon Cancer
An observational study of Colon Cancer, run by Jichao Qin at 1 site in China.
Trial summary
Complete mesocolic excision is currently recognized as a standard procedure for colon cancer. Controversy remains on the presence of right gastroepiploic mesentery metastasis in patients with colon cancer locating at or close to the hepatic flexure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2021to 19 Jul 2028
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the department of GI Surgery of Tongji Hospital
Who may be able to join
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) score I to III
- A biopsy proven histological diagnosis of colorectal carcinoma
- Preoperative staging cT2-4aN0M0 or cTanyN+M0
- tumor located at hepatic flexure or transverse colon close to flexures
- Undergoing complete mesocolic excision with right gastric mesentery resection
- Patients have to be aware of the aim of the trial, and have signed the informed consent.
Who cannot join
- Synchronous colorectal carcinoma
- Clinical evidence of metastasis
- History of colorectal cancer or other malignant tumors
- Preoperative staging cT1N0 or cT4bNany
- Emergency procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
jichao qin, M.D./Ph.D, 008613628683363, jcqin@tjh.tjmu.edu.cn
About this study
Official title: Right Gastroepiploic Mesentery Metastasis in Advanced Colon Cancer Locating at or Close to the Hepatic Flexure
Complete mesocolic excision is currently recognized as a standard procedure for colon cancer. Controversy remains on the presence of right gastroepiploic mesentery metastasis in patients with colon cancer locating at or close to the hepatic flexure. The investigators design this study in order to define the incidence of mesogastrium metastasis and analyse the safety and surgical outcome in these patients who undergo complete mesocolic excision with right gastroepiploic mesentery resection.
Read the detailed description
The development of gastrointestinal surgery has passed over three periods: organ resection, radical resection based on vascular blood vessel center and functional radical organ resection based on membrane anatomy. Using high-definition laparoscopy, surgeons could observe the membrane structure that cannot be identified in traditional open surgery. Total mesocolic excision or complete mesocolic excision has been widely recognized in clinical practice.
In 2009, hohenberger et al. proposed the concept of complete mesocolic excision (CME) for the first time. They retrospectively analyzed the data of 1329 patients with colon cancer who underwent radical resection from 1978 to 2002. They found that the 5-year local recurrence rate decreased from 6.5% to 3.6%, and the 5-year survival rate increased from 82.1% to 89.1%.In 2015, Jianping Gong further introduced the anatomy of mesentery, and highlighted that the radical operation of gastrointestinal tumor should not only complete the traditional D2 or D3 lymph node dissection, but also need the complete excision of the mesentery within the right presumed metastatic tumor cells existingbearing range. On the one hand, its clinical significance lies in reducing intraoperative severe complications; On the other hand, better radical operation and due to avoiding "cancer leakage".
Complete mesocolic excision is currently recognized as a standard procedure for colon cancer. According to the theory of membrane anatomy, the right gastroepiploic mesentery and the mesentery of colon are independent which act as separate envelope. As right gastroepiploic mesentery metastases were classified as distant metastaticmetastasis, radical resection of colon cancer under CME combined with resection of the right gastroepiploic mesentery is not appropriate for patients with colon cancer locating at or close to the hepatic flexure. .
Currently, literatures on the surgical methods and boundary of lymph node dissection for colon cancer are all retrospective studies, and lack of RCT evidence. Controversy remains on the presence of mesogastrium metastasis in patients with colon cancer locating at or close to the hepatic flexure. Therefore, the following questions remain to be addressed: will cancer malignant tumors located locating at or close to hepatic flexure or transverse colon close to flexures metastasize to the right gastroepiploic mesentery (including but not limiting No.6 lymph nodes)? The No.6 lymph node metastasis of No.6 lymph nodes in the patients with colon cancer locating at the hepatic flexure have been reported, but whether the " No.6 lymph nodes " were mixed with lymph nodes in the colon mesentery was unknown. The investigators design this study in order to define the incidence of mesogastrium metastasis in colon cancer locating at or close to the hepatic flexure, and analyse analyze the safety and surgical outcome in these patients undergoing complete mesocolic excision plus right gastroepiploic mesentery resection.
- Conditions
- Colon Cancer
- Keywords
- colon adenocarcinoma, metastasis, right hemi-colectomy
- Medical subject headings
- Colonic Neoplasms, Neoplasm Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
metastasis rate
the incidence of gastric mesentery metastasis
Measured: an average of 1 year
Secondary outcomes (3)
intraoperative complication
intraoperative complication of complete mesocolic excision plus right gastroepiploic mesentery resection
Measured: an average of 1 year
postoperative complication
postoperative complication of complete mesocolic excision plus right gastroepiploic mesentery resection
Measured: an average of 1 year
3-year DFS
3-year disease free survival
Measured: an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start12 Jan 2021
- Primary completion19 Jul 2025
- Study completion19 Jul 2028 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jichao Qin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jichao Qin, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980287
- Sponsor's protocol ID
- TJ-IRB20210649
- Status last verified
- Oct 2026
- First submitted
- 20 Jul 2021
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Gastroepiploic Mesentery Metastasis in Advanced Colon Cancer Locating at or Close to the Hepatic Flexure
- ClinicalTrials.gov ID
- NCT04980287
- Acronym / sponsor ID
- TJ-IRB20210649
- Conditions
- Colon Cancer
- Keywords
- colon adenocarcinoma, metastasis, right hemi-colectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jichao QinUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 19 Jul 2025 (actual)
- Study completion
- 19 Jul 2028 (estimated)
- First posted
- 28 Jul 2021 (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.
Complete mesocolic excision is currently recognized as a standard procedure for colon cancer. Controversy remains on the presence of right gastroepiploic mesentery metastasis in patients with colon cancer locating at or close to the hepatic flexure. The investigators design this study in order to define the incidence of mesogastrium metastasis and analyse the safety and surgical outcome in these patients who undergo complete mesocolic excision with right gastroepiploic mesentery resection.
Detailed description
The development of gastrointestinal surgery has passed over three periods: organ resection, radical resection based on vascular blood vessel center and functional radical organ resection based on membrane anatomy. Using high-definition laparoscopy, surgeons could observe the membrane structure that cannot be identified in traditional open surgery. Total mesocolic excision or complete mesocolic excision has been widely recognized in clinical practice.
In 2009, hohenberger et al. proposed the concept of complete mesocolic excision (CME) for the first time. They retrospectively analyzed the data of 1329 patients with colon cancer who underwent radical resection from 1978 to 2002. They found that the 5-year local recurrence rate decreased from 6.5% to 3.6%, and the 5-year survival rate increased from 82.1% to 89.1%.In 2015, Jianping Gong further introduced the anatomy of mesentery, and highlighted that the radical operation of gastrointestinal tumor should not only complete the traditional D2 or D3 lymph node dissection, but also need the complete excision of the mesentery within the right presumed metastatic tumor cells existingbearing range. On the one hand, its clinical significance lies in reducing intraoperative severe complications; On the other hand, better radical operation and due to avoiding "cancer leakage".
Complete mesocolic excision is currently recognized as a standard procedure for colon cancer. According to the theory of membrane anatomy, the right gastroepiploic mesentery and the mesentery of colon are independent which act as separate envelope. As right gastroepiploic mesentery metastases were classified as distant metastaticmetastasis, radical resection of colon cancer under CME combined with resection of the right gastroepiploic mesentery is not appropriate for patients with colon cancer locating at or close to the hepatic flexure. .
Currently, literatures on the surgical methods and boundary of lymph node dissection for colon cancer are all retrospective studies, and lack of RCT evidence. Controversy remains on the presence of mesogastrium metastasis in patients with colon cancer locating at or close to the hepatic flexure. Therefore, the following questions remain to be addressed: will cancer malignant tumors located locating at or close to hepatic flexure or transverse colon close to flexures metastasize to the right gastroepiploic mesentery (including but not limiting No.6 lymph nodes)? The No.6 lymph node metastasis of No.6 lymph nodes in the patients with colon cancer locating at the hepatic flexure have been reported, but whether the " No.6 lymph nodes " were mixed with lymph nodes in the colon mesentery was unknown. The investigators design this study in order to define the incidence of mesogastrium metastasis in colon cancer locating at or close to the hepatic flexure, and analyse analyze the safety and surgical outcome in these patients undergoing complete mesocolic excision plus right gastroepiploic mesentery resection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the department of GI Surgery of Tongji Hospital
Key inclusion criteria (7 listed)
- Age between 18 and 75 years
- American Society of Anesthesiologists (ASA) score I to III
- A biopsy proven histological diagnosis of colorectal carcinoma
- Preoperative staging cT2-4aN0M0 or cTanyN+M0
- tumor located at hepatic flexure or transverse colon close to flexures
Key exclusion criteria (5 listed)
- Synchronous colorectal carcinoma
- Clinical evidence of metastasis
- History of colorectal cancer or other malignant tumors
- Preoperative staging cT1N0 or cT4bNany
- Emergency procedure
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
metastasis rate
Time frame: an average of 1 year
the incidence of gastric mesentery metastasis
3 secondary outcomes
intraoperative complication
Time frame: an average of 1 year
postoperative complication
Time frame: an average of 1 year
3-year DFS
Time frame: an average of 3 years
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 15 Oct 2026.
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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.
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, run by Jichao Qin 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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?
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 Jichao Qin, M.D./Ph.D (008613628683363, jcqin@tjh.thmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metastasis rate (time frame: an average of 1 year). 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 15 Oct 2026.