MRI-guided Lateral Lymph Node Dissection in Rectal Cancer
Study Details
Study Description
Brief Summary
To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Our study design is a multicenter, prospective, registry study.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Lower rectal cancer patients with a LLN ≥ 5mm Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included. |
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Pathological positive rate [3-year.]
The proportion of patients with positive lateral lymph node which was confirmed pathologically.
- Local recurrence rate [3-year]
The proportion of patients with local recurrence after 3 years of surgery
- Overall survival rate [3-year]
The proportion of patients survived after 3 years of surgery
- Disease free survival [3-year]
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery.
Secondary Outcome Measures
- Early morbidity rate [30 days]
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
- Duration of the surgery [1 day]
The duration of time between the start and the end of the surgery.
- Postoperative complications [30 days]
Complications occurring within 30 days after surgery, mainly urinary and sexual functions.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18-75 years old
-
Pathologically confirmed as rectal adenocarcinoma
-
The tumor is located in the middle or lower rectum
-
Preoperative MRI assessment is T2-4 N+M0
-
Lateral lymph node short diameter ≥ 5 mm (MRI)
-
Signed informed consent
Exclusion Criteria:
-
Previous history of malignant colorectal tumors
-
Multiple abdominal or pelvic surgeries were performed
-
Complicated with bowel obstruction, perforation or bleeding
-
Patients undergoing palliative surgery
-
Patients with severe liver and kidney dysfunction, cardiopulmonary dysfunction, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery
-
Have a history of severe mental illness
-
Pregnant or breastfeeding women （8) Patients previously treated with iliac artery surgery (or its branches)
(9) R0 resection cannot complete (10) ASA grade ≥ IV
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College | Beijing | Beijing | China | 100021 |
Sponsors and Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Shengjing Hospital
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- West China Hospital
- The First Affiliated Hospital of Dalian Medical University
- China-Japan Friendship Hospital
- Peking University First Hospital
- Beijing Friendship Hospital
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Peking University Cancer Hospital & Institute
- The First Hospital of Jilin University
- China-Japan Union Hospital, Jilin University
- Tianjin People's Hospital
- Second Affiliated Hospital of Suzhou University
- Peking Union Medical College Hospital
- Ruijin Hospital
- First Hospital of China Medical University
- Chinese PLA General Hospital
- Zhejiang Cancer Hospital
- The Affiliated Hospital of Xuzhou Medical University
- The Affiliated Hospital of Qingdao University
- Shanghai Cancer Hospital, China
Investigators
- Principal Investigator: Qian Liu, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Epub 2006 Nov 10.
- 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.
- 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.
- 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.
- MALAREC