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| Name | Class |
|---|---|
| Shengjing Hospital | OTHER |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | OTHER |
| West China Hospital | OTHER |
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To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower rectal cancer patients with a LLN ≥ 5mm | Patients with lateral lymph node short diameter ≥ 5mm evaluated by MRI were included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TME+Lateral lymph node dissection. | Procedure | TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological positive rate | The proportion of patients with positive lateral lymph node which was confirmed pathologically. | 3-year. |
| Local recurrence rate | The proportion of patients with local recurrence after 3 years of surgery | 3-year |
| Overall survival rate | The proportion of patients survived after 3 years of surgery | 3-year |
| Disease free survival | The proportion of patients with no disease recurrence and metastasis after 3 years of surgery. | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| Early morbidity rate | The early morbidity rate is defined as the event observed during operation and within 30 days after surgery | 30 days |
| Duration of the surgery | The duration of time between the start and the end of the surgery. |
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Inclusion Criteria:
Exclusion Criteria:
(9) R0 resection cannot complete (10) ASA grade ≥ IV
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Lower rectal cancer patients with lateral lymph node short diameter ≥ 5 mm were included in the study. TME with lateral lymph node dissection was performed in these patients. LLN positive rate, local recurrence rate, 3-year overall survival rate, perioperative complication rate and quality of life were documented and analysed.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Liu, M.D | Contact | 01087787110 | fcwpumch@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qian Liu, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17096053 | Background | 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. | |
| 23963871 | Background |
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The data are available from Qian Liu upon request.
The data were available to all the researchers permanently after this study was done.
All the data will be available to all the relevant researchers in the world upon request. Email: liuqianncc@126.com
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 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 |
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| 1 day |
| Postoperative complications | Complications occurring within 30 days after surgery, mainly urinary and sexual functions. | 30 days |
| 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. |
| 28288057 | Background | 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. |
| 28383446 | Background | 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. |
| 24792010 | Background | 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. |
| 39497010 | Derived | 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. |
| 38091416 | Derived | 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. |
| 36649192 | Derived | 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. |
| 36515808 | Derived | 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. |
| 36033473 | Derived | 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. |
| 35882759 | Derived | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |