MRI-guided Lateral Lymph Node Dissection in Rectal Cancer
NCT ID: NCT04850027
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
268 participants
OBSERVATIONAL
2021-01-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study on the No.253 Lymph Node Metastasis Patterns in Left-Sided Colon and Rectal Cancer
NCT06135571
Significance of Benign Lymph Node Enlargement in Colorectal Cancer
NCT06410729
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
NCT01816607
Fluorescence Laparoscopic Navigation for Rectal Cancer and Sigmoid Colon Cancer
NCT05730595
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
NCT06279299
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
We would enroll 268 patients with lower rectal cancer whose preoperative MRI showed laterally lymph node diameter ≥ 5mm.
The postoperative adjuvant chemoradiotherapy is determined by the pathological results. For patients of stage II and patients of stage III with unfavorable histologic features, six months of adjuvant chemotherapy of fluorouracil-based regimen with radiotherapy of 45.0 \~ 50.5 Gy are recommended.
The postoperative examination should be performed every three months in the first two years and every six months in the following three years.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lower rectal cancer patients with a LLN ≥ 5mm
Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included.
TME+Lateral lymph node dissection.
TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TME+Lateral lymph node dissection.
TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Pathologically confirmed as rectal adenocarcinoma
3. The tumor is located in the middle or lower rectum
4. Preoperative MRI assessment is T2-4 N+M0
5. Lateral lymph node short diameter ≥ 5 mm (MRI)
6. Signed informed consent
Exclusion Criteria
2. Multiple abdominal or pelvic surgeries were performed
3. Complicated with bowel obstruction, perforation or bleeding
4. Patients undergoing palliative surgery
5. Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
6. Have a history of severe mental illness
7. Pregnant or breastfeeding women （8) Patients previously treated with iliac artery surgery (or its branches)
(9) R0 resection cannot complete (10) ASA grade ≥ IV
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shengjing Hospital
OTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
OTHER
West China Hospital
OTHER
The First Affiliated Hospital of Dalian Medical University
OTHER
China-Japan Friendship Hospital
OTHER
Peking University First Hospital
OTHER
Beijing Friendship Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Peking University Cancer Hospital & Institute
OTHER
The First Hospital of Jilin University
OTHER
China-Japan Union Hospital, Jilin University
OTHER
Tianjin People's Hospital
OTHER
Second Affiliated Hospital of Suzhou University
OTHER
Peking Union Medical College Hospital
OTHER
Ruijin Hospital
OTHER
First Hospital of China Medical University
OTHER
Chinese PLA General Hospital
OTHER
Zhejiang Cancer Hospital
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Shanghai Cancer Hospital, China
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qian Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Baik SH, Kim NK, Lee YC, Kim H, Lee KY, Sohn SK, Cho CH. Prognostic significance of circumferential resection margin following total mesorectal excision and adjuvant chemoradiotherapy in patients with rectal cancer. Ann Surg Oncol. 2007 Feb;14(2):462-9. doi: 10.1245/s10434-006-9171-0. Epub 2006 Nov 10.
Akiyoshi T, Ueno M, Matsueda K, Konishi T, Fujimoto Y, Nagayama S, Fukunaga Y, Unno T, Kano A, Kuroyanagi H, Oya M, Yamaguchi T, Watanabe T, Muto T. Selective lateral pelvic lymph node dissection in patients with advanced low rectal cancer treated with preoperative chemoradiotherapy based on pretreatment imaging. Ann Surg Oncol. 2014 Jan;21(1):189-96. doi: 10.1245/s10434-013-3216-y. Epub 2013 Aug 21.
Fujita S, Mizusawa J, Kanemitsu Y, Ito M, Kinugasa Y, Komori K, Ohue M, Ota M, Akazai Y, Shiozawa M, Yamaguchi T, Bandou H, Katsumata K, Murata K, Akagi Y, Takiguchi N, Saida Y, Nakamura K, Fukuda H, Akasu T, Moriya Y; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial. Ann Surg. 2017 Aug;266(2):201-207. doi: 10.1097/SLA.0000000000002212.
Ishihara S, Kawai K, Tanaka T, Kiyomatsu T, Hata K, Nozawa H, Morikawa T, Watanabe T. Oncological Outcomes of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer Treated With Preoperative Chemoradiotherapy. Dis Colon Rectum. 2017 May;60(5):469-476. doi: 10.1097/DCR.0000000000000752.
Furuhata T, Okita K, Nishidate T, Ito T, Yamaguchi H, Ueki T, Akizuki E, Meguro M, Ogawa T, Kukita K, Kimura Y, Mizuguchi T, Hirata K. Clinical feasibility of laparoscopic lateral pelvic lymph node dissection following total mesorectal excision for advanced rectal cancer. Surg Today. 2015 Mar;45(3):310-4. doi: 10.1007/s00595-014-0906-4. Epub 2014 May 3.
Huang F, Wei R, Zhou S, Mei S, Xiao T, Xing W, Liu Q; the Chinese Lateral Node Collaborative Group. The diagnosis and oncological outcomes of obturator and internal iliac lymph node metastasis in middle-low rectal cancer: results of a multicenter Lateral Node Collaborative Group study in China. Discov Oncol. 2024 Nov 4;15(1):618. doi: 10.1007/s12672-024-01500-4.
Tang B, Zhou S, He K, Mei S, Qiu W, Guan X, Liu F, Chi C, Wang X, Tian J, Liu Q, Tang J. Applications of Near-Infrared Fluorescence Imaging and Angiography of Inferior Vesical Artery in Laparoscopic Lateral Lymph Node Dissection: A Prospective Nonrandomized Controlled Study. Dis Colon Rectum. 2024 Jan 1;67(1):175-184. doi: 10.1097/DCR.0000000000002926. Epub 2023 Aug 30.
Zhou S, Zhang H, Liang J, Fu W, Lou Z, Feng B, Yang Y, Xie Z, Liu Q; Chinese Lateral Node Collaborative Group. Feasibility, Indications, and Prognostic Significance of Selective Lateral Pelvic Lymph Node Dissection After Preoperative Chemoradiotherapy in Middle/Low Rectal Cancer: Results of a Multicenter Lateral Node Study in China. Dis Colon Rectum. 2024 Feb 1;67(2):228-239. doi: 10.1097/DCR.0000000000002640. Epub 2023 Jan 4.
Zhou S, Mei S, Feng B, Yang Y, Wang X, Wang Q, Liu Q. Feasibility and safety of lateral pelvic lymph node dissection for elderly patients with middle-low rectal cancer: results of a large multicenter lateral node collaborative group study in China. Tech Coloproctol. 2023 Aug;27(8):655-664. doi: 10.1007/s10151-022-02746-2. Epub 2022 Dec 14.
Zhou S, Tang J, Liang J, Lou Z, Fu W, Feng B, Yang Y, Xiao Y, Liu Q. Effective dissecting range and prognostic significance of lateral pelvic lymph node dissection for middle-low rectal cancer patients with lateral pelvic lymph node metastasis: Results of a large multicenter lateral node collaborative group in China. Front Oncol. 2022 Aug 12;12:916285. doi: 10.3389/fonc.2022.916285. eCollection 2022.
Zhou S, Song Y, Xie Y, Liu Q. Neoadjuvant Chemoradiotherapy Prior to Lateral Lymph Node Dissection in Rectal Cancer with Suspected Lateral Lymph Node Metastasis: a Multicenter Lateral Node Study in China. J Gastrointest Surg. 2023 Jan;27(1):158-161. doi: 10.1007/s11605-022-05425-7. Epub 2022 Jul 26. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MALAREC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.