Clinical trial · Observational
MRI-guided Lateral Lymph Node Dissection in Rectal Cancer
MAgnetic Resonance Imaging Guided LAteral Lymph Node Dissection in Lower REctal Cancer - A Multicenter, Prospective, Registry Study (MALAREC)
NCT04850027CI-TRIAL-00051434unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TME+Lateral lymph node dissection. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Lower rectal cancer patients with a LLN ≥ 5mm
- description
- Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included.
- interventionNames
- Procedure: TME+Lateral lymph node dissection.
Primary outcomes (4)
- measure
- Pathological positive rate
- timeFrame
- 3-year.
- description
- The proportion of patients with positive lateral lymph node which was confirmed pathologically.
- measure
- Local recurrence rate
- timeFrame
- 3-year
- description
- The proportion of patients with local recurrence after 3 years of surgery
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18-75 years old 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: 1. Previous history of malignant colorectal tumors 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
References
Publications (11)
- BACKGROUNDBaik 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. PMID 17096053
- BACKGROUNDAkiyoshi 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. PMID 23963871
- BACKGROUNDFujita 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. PMID 28288057
- BACKGROUNDIshihara 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. PMID 28383446
- BACKGROUNDFuruhata 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. PMID 24792010