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70% of the whole participants would be randomly divided into the training group to build the predicition model.

30% of the whole participant would be divided into the validation group to validate the model

All participted would receive lateral lymph node dissection for rectal cancer.

lateral lymph node dissection

Ziqiang Wang, MD

Xubing Zhang, MD

Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.

Prediction Model for Lateral Lymph Node Metastasis

Radiomics-based Prediction Model for Lateral Lymph Node Metastasis in Rectal Cancer

individual participant data (IPD) would not be available to other researchers.

West China Hospital

Recurrence

advanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo lateral lymph node dissection and total mesorectal excision(LLND+TME)

advanced rectal cancer patients after neoadjuvant chem-radiation with suspicious lateral lymph nodes involvement undergo total mesorectal excision (TME)solely, without LLND

advanced rectal cancer patients whose lymph nodes are suspiciously enlarged after neoadjuvant chemoradiation will undergo lateral lymph node dissection (LLND) and total mesorectal excision (TME)

LLND

labeled line

Ziqiang Wang, MD,PhD

Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) after neoadjuvant chemo-radiotherapy (nCRT) between Western and Eastern countries. Retrospective cohort evidences indicate that LLND following total mesorectal excision (TME) will bring benefit from cT3-4 rectal cancer, not regular predictive LLND, which will bring more side effects on the contrary. Existing reports tend to recommend LLND for specific individual with suspicious LLN metastasis. Moreover, there is a blank strict prospective randomized control study on the comparison of LLND+TME and LLND after nCRT. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.

Recently, the incidence and mortality of colorectal cancer have increased, leading the second prevalence after lung cancer. Local recurrence of mid/low rectal cancer is not only the poor prognostic factor but also the threat of terrible quality of life. Although universal usage of neoadjuvant chemo-radiotherapy (nCRT) and total mesorectal excision (TME) have decreased local recurrence to 5%-10%, the ratio of local recurrence has occupied almost 30% of total metastasis and recurrence incidences, which limited the therapeutic effect of rectal cancer. Increasing evidences have demonstrated lateral pelvic lymph nodes (LLN) metastasis as one of the prominent causes of local recurrence, accompanied with 10%-25% advanced rectal cancer. Published researches also reminder us preoperative LLN involvement may lead to high local recurrence and poor overall survival.

As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes dissection (LLND) or LLND+TME after nCRT:

Eastern countries especially Japan favors LLND following TME with the reasons: 1) the incidence of LLN metastasis reaches as high as 10%-25% and 27% of rectal patients who undergo TME solely (without LLND) will develop into local recurrence. And the predictive pelvic recurrence rate will decrease 50%; corresponding 5-year overall survival will increase 8%-9%. 2) efficacy of LLND equals to resection of "local lymph nodes metastases". A large cohort of 11567 cases from Japan demonstrates resection of iliac lymph nodes metastasis does not show any difference from TME of cTxN2aM0 and resection of obturator and external iliac lymph nodes favors that of liver metastasis. 3) Japanese Guidelines for treatment of colorectal in 2014 also recommends mid/low II/III rectal cancer under peritoneal reflex undergo regular TME+LLND.

On the contrary, western countries favor sole TME after nCRT for LLN metastasis, holding that: 1) rate of lymph nodes metastasis is relatively low and LLN metastasis is regarded as systemic metastasis. 2) LLND experiences longer operative time, higher postoperative complications, and poor quality of life. 3) American NCCN and European ESMO guidelines recommend single TME for rectal cancer, if necessary, LLDN is added when LLN is indeed metastasis.

However, there is a blank strict prospective randomized control study on the comparison of nCRT and LLND. Present existing retrospective cohort mainly focus on all the mid/low advanced cancer, not the specific individual of suspicious LLN metastasis. In fact, the results almost indicate no differences on local recurrence and overall survival, except for less operation time, blood loss, and perioperative complications in LLND. Although the latest researches start to report their preliminary outcomes, the patients sample sizes are small and they achieve varied recurrence and overall survival.

In conclusion, the treatment strategy for colorectal cancer has focused on individual and precision. Massive of retrospective reports have indicated that rectal cancer patients with LLN metastasis will benefit from LLND, however, there is hot controversy on the treatment of whether TME+LLND or TME+nCRT for specific rectal patients with suspicious LLN metastasis. Therefore, our trial will compare the efficacy and safety of the two strategies for mid/low rectal cancer with suspicious LLN metastasis. The risk factors (such as radiologic factors, pathologic factors, and serum protein) to predict local recurrence and overall survival will be further investigated.

Lateral Lymph Node Dissection After Neoadjuvant Chemo-radiation in Advanced Low Rectal Cancer

Lateral Pelvic Lymph Node Dissection After Neoadjuvant Chemo-radiation for Preoperative Enlarged Lateral Nodes in Advanced Low Rectal Cancer: a Phase III Randomized Controlled Trial

Professor

All patients receive CT three-dimensional reconstruction before surgery.

All patients did not receive CT three-dimensional before surgery

All patients will receive CT three dimensional reconstruction before surgery

CT three-dimensional reconstruction

The investigators will perform CT three-dimension reconstruction for middle-low rectal cancer patients who have enlarged lateral lymph nodes to recognize the variance of pelvic vessels, by which to help reduce operative time and blood loss, localize the lateral lymph nodes, improve the lymph node harvested and positive rate. Besides, The investigators will label the vessels near the interested node to achieve node-by-node for further investigation.

CT three-dimensional reconstruction was performed for middle-low patients who had enlarged lateral lymph node before surgery. The main purpose is to recognize the track and variance of pelvic and iliac blood vessels. The investigators want to explore whether this method can help reduce operative time, unexpected injuries and blood loss, and The investigators also want to study whether it can help improve the lymph node harvested and positive rate during lateral lymph node dissection. Besides, The investigators want to perform node-by-node for enlarged lateral lymph node and CT three-dimensional reconstruction can help the investigators to localize and label the interested lymph node during operation. After node-by-node, The investigators can explore the accuracy of radiologists' and surgeons' judgement for lateral lymph node metastasis, and The investigators also want explore the best cut-off value of shorter diameter to predict lateral lymph node metastasis. Besides, The investigators want to perform texture analysis by combination radiology and pathology to find some useful parameters to predict lateral lymph node metastasis.

The investigators also want to explore the feasibility of dissecting the unilateral visceral branch of internal iliac vessels when performing lateral lymph node dissection.

The investigators will have a close follow-up for patients who have enlarged lateral lymph node but do not meet the criteria for lateral lymph node dissection. CT three-dimensional reconstruction can help The investigators recognize which parts' lateral lymph nodes have more potential possibility to metastasis and recurrence.

This group with intervention will be compared previous group without intervention.

Lateral Lymph Node Dissection for Middle-low Rectal Cancer

Prospective Study on Image-guided Internal Iliac Vessels Dissection and Node-for-node for Selected Lateral Lymph Node Dissection in Middles-low Rectal Cancer

including total operative time and that for lateral lymph node

including radiologists' and surgeons' accuracy

The best cut-off value of shorter diameter for lateral lymph node dissection

The blood vessels variance of internal iliac vessels

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prediction Model for Lateral Lymph Node Metastasis	NCT04635488	Rectal Cancer	lateral lymph n...	18 Years - 85 Years	West China Hospital
Lateral Lymph Node Dissection After Neoadjuvant Chemo-radiation in Advanced Low Rectal Cancer	NCT02614157	Rectal Cancer	LLND labeled line	18 Years - 75 Years	West China Hospital
Lateral Lymph Node Dissection for Middle-low Rectal Cancer	NCT03826862	Rectal Cancer	CT three-dimens...	18 Years - 80 Years	West China Hospital
Lateral Lymph Node Dissection After Neoadjuvant Chemo-radiation in Advanced Low Rectal Cancer	NCT02614157	Rectal Cancer	LLND labeled line	18 Years - 75 Years	West China Hospital

Spots Global Cancer Trial Database for lateral lymph node dissection