MRI-guided Lateral Lymph Node Dissection in Rectal Cancer

NCT04850027 | Unknown DMC

• 1 other identifier: MALAREC
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the oncological outcome of lateral lymph node dissection in low rectal cancer based on MRI

Conditions

Rectal Cancer

Keywords

Lateral lymph node; Surgery; Magnetic resonance imaging; oncological outcome

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Early morbidity rate

  30 days

• Duration of the surgery

  1 day

• Postoperative complications

  30 days

Study Arms (1)

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.

Interventions

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.

Lower rectal cancer patients with a LLN ≥ 5mm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Shengjing Hospital: collaborator
• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: collaborator
• West China Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• China-Japan Friendship Hospital: collaborator
• Peking University First Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• The First Hospital of Jilin University: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• Tianjin People's Hospital: collaborator
• Second Affiliated Hospital of Suzhou University: collaborator
• Peking Union Medical College Hospital: collaborator
• Ruijin Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Chinese PLA General Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Shanghai Cancer Hospital, China: collaborator

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (11)

• 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.

  PMID: 17096053 BACKGROUND

• 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.

  PMID: 23963871 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.

  PMID: 28288057 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.

  PMID: 28383446 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.

  PMID: 24792010 BACKGROUND

• 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.

  PMID: 39497010 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.

  PMID: 38091416 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.

  PMID: 36649192 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.

  PMID: 36515808 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.

  PMID: 36033473 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.

  PMID: 35882759 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Qian Liu, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Liu, M.D

CONTACT

01087787110; fcwpumch@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data were available to all the researchers permanently after this study was done.
• Access Criteria: All the data will be available to all the relevant researchers in the world upon request. Email: liuqianncc@126.com

Locations

CN (1)