Colorectal NeoplasmNCT03936530
Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer
An observational study of Colorectal Neoplasm, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
The infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasm
- How many people
- 432 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2019to 1 Aug 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in Shanghai Minimally Invasive Surgery Center
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
- tumor located at hepatic flexure and right half of transverse colon
- Undergoing right hemi-colectomy with extented lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
- Preoperative staging cT2-4aN0M0 or cTanyN+M0
- Willing to participate and informed consent signed
Who cannot join
- Pregnant or lactating women
- Synchronous colorectal carcinoma
- History of colorectal cancer or other malignant tumors
- Clinical evidence of metastasis
- Preoperative staging cT1N0 or cT4bNany
- Emergency procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infrapyloric (No.206) and Greater Curvature (No.204) Lymph Node Metastasis in Adenocarcinoma Located at Hepatic Flexure and Right Half of Transverse Colon
The infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. The aim of this study is to assess the rate of this lymph node metastasis and to reveal its prognostic value for colon cancer located at hepatic flexure and right half of transverse colon. Meanwhile, we can evaluate the safety and feasibility of this extented lymphadenectomy in right hemi-colectomy.
- Conditions
- Colorectal Neoplasm
- Keywords
- colon adenocarcinoma, lymph node metastasis, right hemi-colectomy
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
metastasis rate
metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node
Measured: an average of 1 year
Secondary outcomes (4)
lymphadenectomy time
time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
Measured: an average of 1 year
intraoperative complication
intraoperative complication
Measured: an average of 1 year
postoperative complication
postoperative complication
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 posted3 May 2019
- Study start20 Oct 2019
- Primary completion1 Aug 2023
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmStudies 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
- 432 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936530
- Sponsor's protocol ID
- MISC- Infrapyloric LNM
- Status last verified
- Mar 2024
- First submitted
- 2 May 2019
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yalikun A, Cai Z, Hong HJ, Dai K, Li S, Kwan W, Ma J, Feng B, Lu A, Zheng M, Zang L. Infrapyloric (No. 206) and greater curvature (No. 204) lymph node metastasis in adenocarcinoma located in the right half of the transverse colon (InCLART Study): protocol for a multicentre prospective observational study. BMJ Open. 2023 Feb 21;13(2):e066981. doi: 10.1136/bmjopen-2022-066981.
PubMed 36810166
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrapyloric (No.206) and Greater Curvature (No.204) Lymph Node Metastasis in Adenocarcinoma Located at Hepatic Flexure and Right Half of Transverse Colon
- ClinicalTrials.gov ID
- NCT03936530
- Acronym / sponsor ID
- MISC- Infrapyloric LNM
- Conditions
- Colorectal Neoplasm
- Keywords
- colon adenocarcinoma, lymph node metastasis, right hemi-colectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 3 May 2019 (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 infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. The aim of this study is to assess the rate of this lymph node metastasis and to reveal its prognostic value for colon cancer located at hepatic flexure and right half of transverse colon. Meanwhile, we can evaluate the safety and feasibility of this extented lymphadenectomy in right hemi-colectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Shanghai Minimally Invasive Surgery Center
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
- tumor located at hepatic flexure and right half of transverse colon
- Undergoing right hemi-colectomy with extented lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Synchronous colorectal carcinoma
- History of colorectal cancer or other malignant tumors
- Clinical evidence of metastasis
- Preoperative staging cT1N0 or cT4bNany
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
metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node
4 secondary outcomes
lymphadenectomy time
Time frame: an average of 1 year
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Derived from this study: PubMed 36810166Yalikun A, Cai Z, Hong HJ, Dai K, Li S, Kwan W, Ma J, Feng B, Lu A, Zheng M, Zang L. Infrapyloric (No. 206) and greater curvature (No. 204) lymph node metastasis in adenocarcinoma located in the right half of the transverse colon (InCLART Study): protocol for a multicentre prospective observational study. BMJ Open. 2023 Feb 21;13(2):e066981. doi: 10.1136/bmjopen-2022-066981.
Related trials for Colorectal Neoplasm
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 Colorectal Neoplasm, run by Shanghai Minimally Invasive Surgery Center 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 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 7 Mar 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 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?
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?
On the ClinicalTrials.gov record for NCT03936530, which also lists 1 linked publication.
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 7 Mar 2024.