Short-term outcomes of 47 selective laparoscopic lymph node dissection for rectal cancer: A Retrospective Study

doi:10.21203/rs.3.rs-3996083/v1

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Short-term outcomes of 47 selective laparoscopic lymph node dissection for rectal cancer: A Retrospective Study

https://doi.org/10.21203/rs.3.rs-3996083/v1

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Purpose: The aim of this study is to analyze the safety, feasibility and short-term oncology outcomes of selective laparoscope lateral lymph node dissection(LLND) with total mesorectal excision(TME) surgery.

Methods: Between December 2019 and May 2023, LLND with TME surgery was performed in 47 selected patients with advanced rectal cancer. Surgical complications and 2-year oncology survival outcomes were analyzed in the study.

Results: All 47 procedures were technically successful without the need for conversion to open surgery. The mean operation time was 200.6 minutes (range, 135-321 minutes) and mean estimated blood loss was 92.9 ml (range, 10-2000 ml). The most common postoperative complications were anastomotic(8.5%,n=4), ileus (6.4%, n=3), chyle leakageleakage (4.3%, n=2). Lateral pelvic lymph node metastases(LPNM) was found in 19 (40.4%) patients. When divided into LNP positive or negative groups, there were no significant impact on the OS (94.4%vs100%, Log rank p=0.596) and LFRS(76.7%vs89.6%, Log rank p=0.210) , except DFS (58.3%vs90.2%,Log rank p=0.005). Subgroup analysis showed that there was similar short-tem survival outcomes between pN+ group and internal iliac metastasis group(Log rank p of OS,LFRS,DFS were all＞0.05). LRFS and DFS in obturator or external iliac metastasis group were worse than those in internal iliac metastasis group when the follow-up time was extended(Log rank p of LFRS, DFS were 0.05, 0.063 , respectively).

Conclusion: Selective laparoscopy LLND for rectal cancer are safety and feasibility, and its complications are manageable. Oncology survival outcomes for LPNM limited to the internal iliac are similar to pN+ stage , therefor it should be treated positively.

lateral pelvic lymph node

rectal cancer

survival

surgical dissection

laparoscopic surgery

For low rectal cancer, lymphatic drainage to the iliac vascular system is theoretically present. A retrospective study in Japan showed an overall lateral lymph node metastasis rate of 13.9% for rectal cancer. Moreover, lateral lymph node dissection(LLND) could reduce local recurrence by 50.3% and improve 5-year survival by 8% for T3/ T4 rectal cancer below peritoneal recursion¹. However, LLND significantly prolonged operative time and bleeding, and increased autonomic nerve injury². In the past 30 years, as preoperative neoadjuvant chemoradiotherapy and TME surgery have become the standard treatment mode for low advanced rectal cancer, local recurrence has been well controlled. Therefore, prophylactic lateral lymph node dissection is highly controversial for radical resection of rectal cancer³. Whether or not neoadjuvant therapy is received, the presence of suspected lateral metastatic lymph nodes on preoperative imaging is a high risk factor for postoperative local recurrence^4–6. And other studies found that 20% patients, with LLND surgery after preoperative radiotherapy and chemotherapy, have perform lateral lymph node pathology positive^7–10. In spite of the lack of data support, selective LLND for low rectal cancer is gradually gaining acceptance¹¹.

Therefore, the aim of this study is to to analyze the safety, feasibility and short-term oncology outcomes of selective laparoscope LLND with or afte TME surgery.

Patients

Between December 2019 and May 2023, laparoscope LLND with TME surgery was performed in 47 selected patients with advanced rectal cancer. All patients were underwent laparoscopic LLND. The patients were included based on the following inclusion criteria: (1) patients suspected LPNM before treatment based on MRI evaluation. (2) pathologically confirmed rectal adenocarcinoma. (3) age between 18 to 75. The criteria for suspicious LPNM are as follows: (1) ≥ 7 mm in short diameter; (2) short diamete<7mm,but having high risk factors,such as irregular shape and rough edges, inhomogeneous or intense enhance, the short-length-diameter ratio<0.8; (3) short diameter>7mm before chemoradiotherapy, but still>5mm after chemoradiotherapy. The exclusion criteria were as following: (1) presence of simultaneous distant metastases, and cannot reach to NED. (2) having undergone local resection or R2 resection.

The ethics committee of Zhangzhou Hospital Affiliated of Fujian Medical University approved this retrospective study (2023LWB289), and it conformed to the ethical standards of the World Medical Association Declaration of Helsinki.

Data Collection

Information regarding patient demographics, tumor characteristics, and clinical outcomes was obtained. This also included body mass index(BMI), tumor size, tumor distance from the anal verge, and neoadjuvant therapy. Perioperative details included operative time, estimated blood loss, postoperative stay(began from surgery) and complications. Survival outcomes were assessed using 2 year overall survival (OS), local recurrence-free survival(LFRS), desease-free survival(DFS) between subgroup.

In this study, the LPN was defined as the lymph node located in the lateral pelvic area, including three regions: the obturator, internal iliac, and external iliac regions. The transverse short-axis diameter of the largest LPN was assessed using MRI and was measured and set as a representative value. Tumor staging was performed using the American Joint Committee on Cancer (AJCC) staging system (8th edition)¹², based on the available information after surgery (pTNM). OS was counting from the date of LLND surgery.

Postoperative complications were defined as events that occurred within 30 days of surgery. Patients who had been discharged from the hospital were followed up by outpatient visits until 1 month after surgery. Postoperative complications were categorized according to the Clavien–Dindo classification¹³. Severe complications were described as grade III-V. Urinary retention was defined as replacement of the catheter after removal due to dysuria or residual urine volume > 50 ml in the bladder, as examined by an ultrasound.

Treatment

In this study, patients with T4 stage, N2 stage, LPN short diameter ≥ 1.0 cm or positive circumferential margin were subjected to receive neoadjuvant therapy. Treatment strategies for other patients, such as the choice of neoadjuvant therapy (chemotherapy or chemoradiotherapy), were determined by patient’s own wishes and multidisciplinary team meetings that incorporated radiologists, medical and surgical oncologists. Surgery was performed 6–8 weeks after the completion of CRT. Unilateral or bilateral LPND was performed according to the location of the enlarged LPNs detected by preoperative MRI. Bilateral LPND was not performed routinely unless preoperative MRI suggested bilateral LPNM. Patients with stage III and high-risk stage II (CRM ≤ 1 mm, pT4, tumor perforation, lymphatic invasion, perineural invasion) disease underwent adjuvant chemotherapy after surgery. For patients who underwent neoadjuvant therapy, a total of 6 months of perioperative chemotherapy was performed, regardless of pathological stage.

All patients underwent a laparoscopic procedure. LLND was performed in four steps using surgical landmarks. The first step was a dissection of uretero-hypogastric fascia, which envelopes the ureter and the hypogastric nerve. The second step was a dissection of the medial side of the external iliac vein located at the lateral border of the obturator LPN group. The third step was a dissection of the vesico-hypogastric fascia, which is at the medial border of the obturator LPN group. The final step was a dissection of the internal iliac artery until the Alcock’s canal.

Statistics

Categorical and continuous variables were compared using the chi-squared test and t-test, respectively. LRFS, DFS, and OS were assessed using the Kaplan–Meier method and compared using the log-rank test. SPSS (Version 20.0; IBM Corp., Armonk, NY, USA) was used to perform all computations and Graphpad Prism was used to draw diagrams. All reported p values were two-sided, p value < 0.05 was considered to be statistically significant.

Details of patients

Patient details are shown in Table 1. A total of 47 consecutive patients [average age60.1 ± 11.1 (35–83) years; 28 men and 19 women] were included. The distance of the tumour from the anal verge was 4.9 ± 1.8 cm (mean SD; range 1–10 cm). Unilateral LLND was performed in 42 (89.4%) and bilateral LLND in 5 (10.6%).Of 47 patients. 22(47.8%) patients received neoadjuvant therapy, of which 13 received chemotherapy and 9 received chemoradiotherapy.

Table 1

Details of patients.
Characteristics	Values
Gender (%)
Male	28(59.6%)
Female	19(40.4%)
Age (years), mean SD (range)	60.1 ± 11.1 (35–83)
BMI, mean SD (range)	22.8 ± 2.4(18.2–28.1)
Distance of tumour from the AV (cm), mean SD (range)	4.9 ± 1.8(1–10)
Rectal tumor location(%)
>5cm from AV	14(29.8%)
≤ 5cm from AV	33(70.2%)
Neoadjuvant therapy( (%)
No	25(53.2%)
chemotherapy	13(27.7%)
chemoradiotherapy	9(19.1%)
Distant metastasis (%)
No	38(80.9%)
Yes	9(19.1%)
Average diameter of LPN(mm), mean SD (range)	10.6 ± 5.5(4.5–27.0)
Values are presented as number (%) or median SD(range). BMI,included body mass index; AV, anal verge; LPN,lateral pelvic lymph nodes.

Perioperative outcomes

All 47 procedures were technically successful without the need for conversion to open surgery (Table 2). Unilateral LLND was performed in 42 (89.4%) and bilateral LLND in 5 (10.6%). The mean operation time was 200.6 minutes (range, 135–321 minutes) and mean estimated blood loss was 92.9 ml (range, 10−2000 mL). The mean postoperative stay was 12.4 days (range, 5–93 days) and time to removal of the urinary catheter was 6.3 days (range, 3–34 days).

Table 2

Perioperative outcomes
Variable	Value
Bilaterality of LLND
Bilateral	5(10.6%)
Unilateral	42(89.4%)
Operation time (min),mean SD (range)	200.6 ± 40.1(135–321)
Estimated blood loss (mL), mean SD (range)	92.9 ± 288.1(10−2000)
postoperative stay(day)	12.4 ± 13.5(5–93)
Time to removal of the urinary catheter (day)	6.3 ± 5.5(3–34)
Postoperative complication
Clavien III-V	5(10.6%)
Anastomotic leakage	4(8.5%)
Ileus	3(6.4%)
Chyle leakage	2(4.3%)
Urinary retention	2(4.3%)
Ureteral fistula	3(6.4%)
Hyperdrainage	10 (21.3%)
Abdominal infection	2(4.3%)
Wound infection	2(4.3%)
Mortality within 30 days after surgery	0
LPN positve	19/47(40.4%)
LPN negative	28/47(59.6%)
LPNM region
Internal iliac	13/19(68.5%)
Obturator	2/19(10.5%)
External iliac	2/19(10.5%)
Mixed	2/19(10.5%)
The day of length of hospital and removal of the urinary catheter was began from surgery. LLND,lateral lymph node dissection;LPNM,lateral pelvic lymph node pathological metastases.

Within 30 days after the operation, 22 patients (46.8%) developed Clavien grade I-II postoperative complications, while 5 patients (10.6%) experienced severe complications. The most common postoperative complications were anastomotic (8.5%,n = 4), ileus (6.4%, n = 3), chyle leakageleakage(4.3%, n = 2), urinary retention (4.3%, n = 2), ureteral fistula (4.3%, n = 2), wound infection (4.3%, n = 2). There was no mortality within 30 days.

Survival outcomes

The mean follow-up period was 19 months, and during the entire follow-up period, 2 of the 39 patients died, while 6 experienced a local recurrence or distant metastasis. When divided into positive LPN and negative LPN groups, there wre no significant impact on the 2Y-OS (94.4%vs100%, Log rank p = 0.596) and 2Y-LFRS(76.7%vs89.6%, Log rank p = 0.210). However, it should be noted that patients with positive LPN had a significantly worse PFS than negative LPN(58.3%vs90.2%,Log rank p = 0.005,Fig. 1).

Furthermore, we excluded patients with distant metastases(n = 9) for subgroup analysis of LPNM in different regions. We divided to 3 groups, there were moseractal node metastasis but without LPN metastasis (pN + stage), LPN metastasis to internal iliac only(Internal iliac only group), LPN metastasis to obturator or external iliac (Obturator or external iliac group), respectively. The results of subgroup analysis showed that there were similar short-tem survival outcomes between pN + group and internal iliac metastasis group(Log rank p of OS, LFRS, DFS were all >0.05). But LRFS and DFS in obturator or external iliac metastasis group were worse than those in internal iliac metastasis group when the follow-up time was extended(Log rank p of LFRS, DFS were 0.05, 0.063, respectively, Fig. 2).

One of the reasons why LLND surgery is not routinely performed is because of the high risk and complications of the procedure. In our study, about half of patients developed Clavien grade I-II postoperative complications, while 5 patients (10.6%) experienced severe complications. The most common postoperative complications were anastomotic(8.5%,n = 4), ileus (6.4%, n = 3), chyle leakageleakage (4.3%, n = 2), urinary retention (4.3%, n = 2), ureteral fistula (4.3%, n = 2), wound infection (4.3%, n = 2). There was no mortality within 30 days. It shows that the complications of the operation are manageable. However, it is worth noting that more than half of the serious complications occur in the early stages of surgery, so LLND + TME surgery needs to be performed by an experienced specialist and needs a period of learning curve. The mean operation time was 200.6 minutes (range, 135–321 minutes) and mean estimated blood loss was 92.9 ml (range, 10−2000 mL). The shorter operation time and reduced blood loss of patients who underwent LLND in the present study might be explained by more use of the laparoscopic approach and low rate of bilateral LLND. Laparoscope LLND + TME has been reported in selected centers performing high-volume surgery, which have the similar result. Konishi et al.¹⁴reported that laparoscopic LLND resulted in a small amount of blood loss (mean, 25 mL; range, 5–1, 190 mL) and shorter operation time (mean, 413 minutes; range, 277–596 minutes). Park et al.^{15, 16}also reported better results for minimally invasive LLND surgery, with a mean total operative time of 321.9 minutes (range, 220–510 minutes) and mean operative blood loss of 188 ± 104 mL (range, 50–370 mL). Results from a multicenter randomized controlled non-inferiority trial (JCOG0212) in Japan showned that similar Clavien-Dindo III and IV postoperative complications between the LLND and TME-alone groups³. Recently, Akiyoshi et al. ¹⁷ reported a retrospective study that had similar rates of postoperative complications between the TME with LLND and TME-alone groups.

Another reason which make LLND surgery controversial is that the role of LLND surgery in advanced low rectal cancer remains undefined. A study from Japan¹ which was lateral preventive dissection showed that the positive rate of lateral lymph nodes dissection was 13.9%. A study in Korea¹⁸ selectively performed LLND to patients with lateral lymph nodes of ≥ 5 mm in short axis diameter on pretreatment MRI showed that the positive rate was 34.8%. In the present study, which was selective lateral dissection also, the pathologic positive rate of LPN was 40.4%, and even as high as 64.7% in LPN with initial short diameter greater than 10mm. With the improvement of the diagnostic criteria of LPN, the pathologic positive rate is also increasing. However, the preoperative diagnostic criteria for LPN are still unclear.

To our knowledge, the JCOG0212 trial³ is one of the rare reports of long-term survival outcomes about LLND. It showed a similar 5-year RFS and OS in the TME with LLND and TME-alone groups. But TME with LLND had a lower local recurrence, especially in the lateral pelvis, compared to TME alone. It should be noted that this study was preventive dissection and LLND was performed on lateral lymph nodes with images less than 10mm. Another multicenter study from Korea¹⁹ found, LPN short-axis diameter (< 5, 5–<10, and 10 mm) was significantly associated with LPN recurrence-free survival (5-year survival rate (5YSR), 98.2, 91.7, and 40.1%, respectively, P < 0.05), locoregional recurrence-free survival (5YSR, 95.5, 87.6, and 40.1%, respectively, P < 0.05), relapse-free survival (5YSR, 76.8, 72.5, and 30.3, respectively, P < 0.05), and overall survival (5YSR, 86.3, 83.0, and 57.5%, respectively, P < 0.05). A multicenter study from China²⁰ found that the 3-year OS, RFS, and LRFS in the LPN positive group were significantly worse than those in the LPN negative group. But further subgroup analysis showed that patients with LPN metastasis limited to the internal iliac and obturator regions achieve a long-term survival benefit from LLND, and their prognoses may be comparable to those at the N2b stage. In our study, we found that 2-year OS and LRFS were not significant in the LPN positive and negative groups. However, patients with positive LPN had a significantly worse PFS than negative LPN. This suggested that the reason for the failure of LLND was distant metastasis, which also the reason why our study tended to choose chemotherapy as neoadjuvant therapy. But whether chemotherapy played a more important role in neoadjuvant therapy was still up for debat. Interestingly, by subgroup analysis, we found LPNM limited to the internal iliac may have similar short-term tumor outcomes to p-N + stage. Moreover, LPNM come from obturator or external iliac nodes have worse LRFS and DFS than those limited to the internal iliac. We analysed those LPNM are not limited to internal iliac, and we found that the causes of treatment failure were distant metastasis and local recurrence. Correspondingly, external iliac lymph nodes metastasis had a higher rate of distant metastasis, which often accompanied by common iliac lymph nodes and retroperitoneal lymph nodes metastasis. Therefore, external iliac lymph nodes metastasis may be a type of systemic metastasis and requires systemic treatment. The failure of obturator lymph node metastasis may be due to the narrow and complicated anatomical space, which may lead to surgical residue or easy diffusion caused by compression. Preoperative local radiotherapy may be more necessary for these patients. Therefor, our study results may suggest that LPNM limited to intrailiac may be the optimal surgical population for LLND.

This study had several limitations. First, as this study was retrospective, inherent and unintentional selection bias cannot be dismissed. Second, the study population was too small to avoid bias. Third, the average BMI of all patients in this study was 22.4 kg/m2, which was significantly lower than that of patients in Western countries. Rectal dissection and LPND may be more technically difficult in obese patients; thus, more patients with a larger range of BMI would undermine the generalizability of this study. Finally, the mean follow-up time of the whole study was only 19 months, which is difficult to show the relationship between LLND and long-term outcomes. However, our study confirmed that laparoscopy LLND is safe, controllable, and limited to lateral iliac metastasis can achieve better survival, so it is worth reporting.

Selective laparoscopy LLND for rectal cancer are safety and feasibility, and its complications are manageable. Selective laparoscopy LLND also has a higher pathologic positive rate. However, it needs to be performed by an experienced specialist and needs a period of learning curve. Oncology survival outcomes may indicate that LPNM limited to the internal iliac will have a survival outcome similar to pN + stage and it should be treated positively.

Acknowledgements

Not applicable.

Authors’ contributions

Dr.Xiajuan Xue conceived the idea, wrote the main manuscript and conributed to most aspects of the work. Dr. Yincong Guo colledted data and revised the manuscript. Dr.Shuijie Lin wrote the first draft and collected data. Dr.Qunzhang Zeng prepared figures and Tables.All authors reviewed the manuscript.

Funding

None.

Ethics approval and consent to participate

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Institutional Research Ethics Committee of Zhangzhou Hospital Affiliated of Fujian Medical University ( (2023LWB289).As a retrospective study, informed consent was exempted from an ethics committee.

Consent for publication

Written informed consent for publication was obtained from all participants.

Availability of data and materials

The data are available from Zhangzhou hospital database. To obtain the data from this study, please contact Dr. Xiajuan Xue at [email protected].

Competing interests

We declare that we have no financial and personal relationships with other people or organizations that can inappropriately influence our work, there is no professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented in, or the review of, the manuscript entitled.

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No competing interests reported.

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Version 1

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Short-term outcomes of 47 selective laparoscopic lymph node dissection for rectal cancer: A Retrospective Study

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Version 1

Abstract

Figures

INTRODUCTION

Materials and methods

Patients

Data Collection

Treatment

Statistics

RESULTS

Details of patients

Perioperative outcomes

Survival outcomes

Discussion

CONCLUSION

Declarations

References

Additional Declarations

Status:

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