Comparative Effectiveness of Minimally Invasive Surgery vs Open Surgery in neuroblastoma

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Data may be preliminary. 25 March 2024 V1 Latest version Share on Comparative Effectiveness of Minimally Invasive Surgery vs Open Surgery in neuroblastoma Authors : Zhang Jun [email protected] , Lan Qin , Zhenzhen Zhao , XiangRu Kong , Yonggang Li , Chao Yang , Xiaobing Deng , Liang Peng , LinYa Lv , ChangChun Li , and Shan Wang 0000-0002-4562-2247 Authors Info & Affiliations https://doi.org/10.22541/au.171133818.81168488/v1 310 views 137 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Purpose: To explore the feasibility of minimally invasive surgery（MIS）used in the treatment of neuroblastoma. Methods: Selected NB patients were randomly assigned to the MIS group and the open surgery（OS） group. The operative details, major complications, and prognosis of the two groups were compared. Results: A total of 35 children undergoing MIS and 35 children undergoing open surgery were enrolled in this study. According to the INRGSS staging system, 30 patients were classified as stage L1, 32 as stage L2, and 8 as stage M. No statistical difference was found in the age of the children and the maximum diameter of the primary site tumor between the two groups. The bleeding volume in the OS group was significantly higher than that in the MIS group (P=0.006), The time to start postoperative feeding in the MIS group was significantly shorter than that in the OS group (P<0.001). No significant difference was found in the number of GTR between the MIS group and the OS group (P=0.246). The one-year survival rate and overall survival rate of the MIS group were 100% and 93.85%, while the OS group was 100% and 93.72%, respectively. Conclusion: MIS has more advantages than OS for suitable neuroblastoma, while the prognosis is almost the same. After gradually improving the indications for MIS, it should become the preferred surgical method for children within this range. TITLE PAGE Original Articles Comparative Effectiveness of Minimally Invasive Surgery vs Open Surgery in neuroblastoma Lan Qin, M.D., Zhenzhen Zhao, M.D., Ph.D. XiangRu Kong, M.D., Yonggang Li, M.D., Ph.D. Chao Yang, Ph.D. M.D., Xiaobing Deng, M.D., Liang Peng, M.D., LinYa Lv, M.D., Ph.D., ChangChun Li, M.D., Shan Wang, M.D., Ph.D. and Jun Zhang*, M.D., Ph.D. Department of Surgical Oncology Children’s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity. Correspondence to: Dr. Zhang Jun, Department of Surgical Oncology, Children’s Hospital of Chongqing Medical University, 136 Zhongshan 2nd Road, Yuzhong District, Chongqing, 400014 China, Tel.:+86-23-63632054(phone), Fax: +86-23-63635056 (fax), Email: [email protected] . Main Text word count: 4441; Abstract word count: 232; A short running title: Minimally Invasive Surgery vs Open Surgery in Neuroblastoma Funding Source: The Health Commission of Chongqing (2021MSXM298). Table: 2 Figures: 5 Supporting Information files：1 Key Words: Neuroblastoma; Minimally Invasive Surgery; Open Surgery; MIS minimally invasive surgery OS open surgery INRGSS International Neuroblastoma Risk Group staging system IDRFs image-defined risk factors GTR gross total resection GGN ganglioneuroma GGNBL ganglioneuroblastoma NBL neuroblastoma Abstract: Purpose: To explore the feasibility of minimally invasive surgery（MIS）used in the treatment of neuroblastoma. Methods: Selected NB patients were randomly assigned to the MIS group and the open surgery（OS） group. The operative details, major complications, and prognosis of the two groups were compared. Results: A total of 35 children undergoing MIS and 35 children undergoing open surgery were enrolled in this study. According to the INRGSS staging system, 30 patients were classified as stage L1, 32 as stage L2, and 8 as stage M. No statistical difference was found in the age of the children and the maximum diameter of the primary site tumor between the two groups. The bleeding volume in the OS group was significantly higher than that in the MIS group (P=0.006), The time to start postoperative feeding in the MIS group was significantly shorter than that in the OS group (P<0.001). No significant difference was found in the number of GTR between the MIS group and the OS group (P=0.246). The one-year survival rate and overall survival rate of the MIS group were 100% and 93.85%, while the OS group was 100% and 93.72%, respectively. Conclusion: MIS has more advantages than OS for suitable neuroblastoma, while the prognosis is almost the same. After gradually improving the indications for MIS, it should become the preferred surgical method for children within this range. INTRODUCTION Neuroblastoma (NB) is the most common extra-cranial malignant tumor in children. A patient with newly diagnosed neuroblastoma can be treated with a wide range of therapies including observation only, surgery, chemotherapy, radiation, immunotherapy, differentiation therapy, and autologous stem cell transplant. Surgical resection is a crucial part of its treatment, and some children can be cured by surgical resection alone [1]. Now, MIS (minimally invasive surgery) has been increasingly used in the surgical treatment of adult malignant tumors and is considered to shorten the length of hospital stay and reduce the incidence of postoperative complications without affecting the long-term survival rate of patients compared with OS (open surgery) [2-5]. However, whether MIS can be used in children’s malignant tumors is controversial. Although there is no definite research evidence that MIS can affect the prognosis and staging of children’s tumors, some scholars still believe that MIS will have adverse effects on children with tumors [6]. In recent years, more and more pediatric surgeons have applied MIS to the treatment of NB. To explore the feasibility of MIS used in NB, eligible children with NB in our hospital were randomly assigned into the MIS group or OS group since January 2015, and the intraoperative, postoperative, and prognosis of the two groups were compared. The research is summarized as follows. PATIENTS AND METHODS Study design We conducted a prospective study in our hospital, but due to the particularity of the tumor disease, the choice of surgical methods for all patients could not be completely random. The study was approved by the Human Research Ethics Committee. For those children whose tumor volume is too large or the tumor has serious invasion and encapsulation of nearby blood vessels and organs, we first choose OS. Those tumors that are contrary to the above situation were randomized as MIS group and OS group. A total of 289 children with thoracic and abdominal neuroblastoma underwent surgical treatment at the Children’s Hospital of Chongqing Medical University from January 2015 to June 2023. Children who underwent surgery only for partial tumor resection were excluded from the study. To ensure the accuracy of our results, we did not include all children treated with open surgery in the final study objective. Instead, patients treated with MIS were maximally propensity-matched with all children treated with open surgery in a 1:1 ratio on the following variables: Age, maximum tumor size, tumor location, preoperative INRGSS stage, pathological type, date of surgery, and MYCN gene amplification. Finally, a total of 35 children undergoing MIS and 35 children undergoing open surgery were enrolled in this study. （Consort diagram in Fig1） Patients All patients with NB were diagnosed according to the diagnostic criteria of the International Neuroblastoma Pathology Committee (NBP). All cases that underwent surgical treatment obtained pathological diagnosis results after surgical resection. They were staged according to the International Neuroblastoma Risk Group Staging System (INRGSS) according to the results of the last imaging examination before surgery. The determination of IDRFs is made jointly by radiologists and surgeons. To facilitate the development of MIS, children with stage M without IDRFs at the primary site were defined as stage M1, and those with one or more IDRFs were defined as stage M2. The patients were divided into three groups: Gross total resection (GTR), incomplete gross resection (resection extent greater than 95%), and incomplete resection (resection extent less than 95%). The intraoperative events were obtained from the records of the surgeons and anesthesiologists. In addition, the time to start postoperative feeding was calculated. Since the day of surgery, we followed up on the prognosis of the children through the outpatient clinic, hospitalization, telephone, and email. Abdominal operative procedure If the tumor is located in the left adrenal gland area, the child is placed in a lying position tilted 60° to the right after being given general anesthesia. The pneumoperitoneum was established through the umbilical trocar, starting with low flow and maintaining abdominal pressure at 10 to 12 mm Hg. The other two trocars were placed in the left upper abdomen. An electrosurgical or ultrasonic scalpel device was used for dissection. The left mesocolon was fully separated along the retroperitoneal space after the diaphragmocolic ligament and gastrocolic ligament were cut, allowing it to slide naturally to the right abdominal cavity, fully exposing the prerenal fascia of the middle and lower poles of the left kidney. Dissect the splenorenal ligament and splenophrenic ligament along the surface of the perinephric fascia, and fully free and turn the spleen until the stomach fundus can be seen. Thus, the spleen can naturally slide down to the right side of the abdominal cavity. Separate the pancreatic tail against the perinephric fascia and turn it down to expose the left renal vein. Gently open the left renal vein sheath to expose the left adrenal vein. Separate and expose about 1-2cm of the left adrenal vein, and cut the left adrenal vein after clamping with hem-o-lock. The perinephric fascia is then opened to expose the edge of the adrenal tumor. Completely separate the adrenal tumor from the kidney with the ultrasonic scalpel bluntly or sharply. Cut off the blood vessels and tissues between the adrenal tumor and the abdominal aorta after clamping with hem-o-lock, and completely remove the adrenal gland and tumor. (see Fig. 2) When the tumor is located in the right adrenal gland area, the patient is placed in a lying position tilted 45° to the left. Use a liver retractor to block upwards the liver, and use an ultrasonic scalpel to incise the hepatorenal ligament along the lower edge of the liver to fully expose the adrenal gland and the upper edge of the adrenal tumor. Open the peritoneum along the right edge of the inferior vena cava. Create a new auxiliary hole of 5 mm, use intestinal forceps to gently press the upper pole of the kidney in the direction of the foot side, use the ultrasonic scalpel to open the renal capsule, separate the lower part of the adrenal tumor to the psoas major muscle, and separate adrenal glands and tumors along the plane of the psoas major muscle, cut off the inferior adrenal artery with ultrasonic scalpel and hem-o-lock, ligate the central adrenal vein with hem-o-lock. Detach the adrenal gland and tumor from the diaphragm and lower edge of the liver, tie up the superior adrenal artery with hem-o-lock, and remove the adrenal gland and tumor as a whole. (see Fig. 3) If enlarged lymph nodes are found in the renal hilum during the operation, the renal artery and vein sheaths need to be opened first. After the renal arteries and veins are fully freed, they should be pulled with traction belts respectively to protect the ureters and renal blood vessels and remove the enlarged lymph nodes. (see Fig. 4) The resected tumor is placed in a specimen removal bag and removed from the enlarged umbilical or lower abdominal incision. Statistical analysis The software used for data analysis was SPSS.18. Continuous variables (amount of hemorrhage, operation time, maximum tumor size) were compared by the Mann-Whitney test, and categorical variables (extent of surgical resection) were compared by Fisher’s exact test. The survival rate was calculated by K-M survival analysis. All results were presented as P <0.05 was statistically significant. RESULTS A total of 70 children were finally included in our study (see Supplementary Table 1 for details). Among them, there were 35 cases in the MIS group and 35 cases in the OS group. The disease sites in both groups were the abdomen in 27 cases and the chest in 8 cases. The IRRGSS stage, IDRF number, MYCN status, and pathological tissue type of the two groups of children were the same, and there was no statistical difference in age and tumor size ( P =0.751). (See Table 1 for details). Statistical analysis was performed on the surgical results respectively. The amount of bleeding in the OS group was significantly higher than that in the MIS group ( P =0.006). In terms of operation time, the operation time of the MIS group was longer than that of the OS group ( P =0.008). The time to resume eating after surgery was significantly shorter in the MIS group than in the OS group ( P <0.001). No significant difference was found in the number of GTR for the primary site tumors between the two groups ( P =0.493). There was no significant statistical difference in the postoperative overall survival rate between the two groups of children ( P =0.901). (See Table 2 and Fig 5 for details) The IDRFs of the two groups of patients included tumor invasion of the ipsilateral renal pedicle, tumor compression of the ipsilateral main bronchus, tumor surrounding important blood vessels, tumor infiltration of more than 1/3 of the spinal canal, and tumor simultaneously involving the chest, neck, or abdominal cavity. Among the 35 children in the MIS group, 2 children were converted to open surgery during the operation. A child with neuroblastoma primary in the abdomen had 2 IDRFs. The part of the tumor that extended to the chest could not be removed laparoscopically during surgery and added another open subcostal incision for resection. Another child with stage L2 neuroblastoma of the chest was converted to open surgery because the tumor invaded the diaphragm and caused severe adhesion. Regarding 2 children in the MIS group who did not achieve GTR, one case was due to the extension of the thoracic neuroblastoma into the neck. Another case was a thoracic ganglioneuroma infiltrated into the adjacent spinal canal. All 35 children in the OS group achieved GTR. One child with thoracic neuroblastoma developed severe chylothorax after open surgery, The child fasted for 8 days and received total parenteral nutrition before recovering. The remaining patients did not experience any serious complications after surgery. DISCUSSION Neuroblastoma is the most common extracranial solid tumor in children, and surgical treatment is an extremely important treatment step that cannot be ignored. The benefits of MIS are well recognized, as it directly displays a multiple increase in tissue, providing surgeons with more anatomical details and a better view than open surgery [7]. At the same time, for patients, the smaller incision has a better postoperative cosmetic effect, reduces intestinal adhesion, and reduces postoperative pain and other discomfort [8-9]. However, some doctors still believe that CO2 may cause changes in the biological properties of tumors during minimally invasive surgery [10], although clinical trials have not proved this. Our study showed no significant difference in the 1- and 5-year survival rates between the MIS group and the OS group. This is consistent with the conclusions of some retrospective studies [11-14]. Moreover, the intraoperative bleeding volume and postoperative recovery time of the MIS group were significantly better than those of the OS group. However, in terms of surgical time, our study indicates that the OS group has a shorter surgical time compared to the MIS group. This is different from the current studies. WeiYao and Chiyoe Shirota’s previous retrospective studies showed that there was no significant difference in the operation time between the MIS group and the OS group [14-15]. However, the study by Hannah M.Phelps and colleagues showed that MIS can significantly shorten the operation time [11]. We suspect that the reason is that previous relevant retrospective studies did not perform similar matching, so children in different groups had different statistical differences in tumor stage and volume, resulting in large differences in the difficulty of surgery. Additionally, this may be related to the inclusion of more L2 and M2 stage patients in this group. Chest NB accounts for 15% of neuroblastoma in all sites. Compared with the controversy of minimally invasive surgery for abdominal NB, minimally invasive surgery for thoracic NB has been more widely recognized [16-18]. At present, it has been suggested that thoracoscopic surgery can be used as a standard surgical method for mediastinal tumors, regardless of the degree of malignancy of the tumor [18-19], without the limitation of tumor size [20]. One reason is that many studies have shown that compared with abdominal NB, thoracic NB has better biological characteristics and is limited [21], so it can bring a better prognosis, so it is easier to accept even if it cannot be gross-total resected [19]. The second reason is that in addition to the general advantages of MIS that we have studied above, such as reduced bleeding, rapid return to diet after surgery, etc., MIS can also reduce the complications of classic thoracotomy, such as shoulder and arm dysfunction, scoliosis, and Chronic pain syndrome [20,22]. However, there is no unified standard for the indication of minimally invasive surgery for neuroblastoma. In clinical practice, it often depends more on the professional knowledge and technical proficiency of the surgeon. At present, the relevant studies are discussed from the number of primary tumors with IDRFs and tumor size. Some authors have argued that local tumors without radiographic risk factors should be considered an indication for minimally invasive surgery based on the International Neuroblastoma Risk Group staging System (INRGSS) [12,14,23]. However, at the same time, some studies have suggested that the existence of IDRFs should not be a contraindication for minimally invasive surgery [24], and the existence of some IDRFs (tumor-invading renal pedicle) does not affect the surgical results [23,25]. In our study, most of the tumors with IDRF were invading the renal pedicle. No significant difference was found in the degree of resection between the children with negative IDRFs (n=16) and those with positive IDRFs (n=19) in the endoscopic group ( P =0.713). Furthermore, the requirement for tumor size in minimally invasive surgery is generally a maximum diameter of<5 cm or a volume ofa diameter of ≥ 5 cm in the primary site before surgery, and all achieved GTR. No significant statistical difference existed compared to children with a maximum tumor diameter of0.05), which is sufficient to prove that there is no significant relationship between tumor size alone and the degree of complete tumor resection to a certain extent. At the same time, some studies also believe that the maximum tumor volume that can be removed by minimally invasive surgery is related to the height of the child, which increases with the increase of the child’s height, so the indication of minimally invasive surgery for the child should be calculated according to the child’s height at the time of surgery [27]. This statement has a certain reason, but it has not been certified by other institutions. Overall, our study showed that it is not reasonable to choose the surgical modality based solely on the size of the tumor at the primary site or the number of primary sites with IDRFs. When the primary tumor does not have or only has the IDRF of tumor invading the renal pedicle, MIS can be recommended for tumor resection if the maximum diameter of the tumor is less than 5cm. If the tumor diameter is greater than 5 cm, MIS is not an absolute contraindication, and the surgical method should be selected according to the proficiency of the surgeon. There were too few cases of other IDRFs in this study to explore the effect of each IDRF on the outcome of minimally invasive surgery. In the future, larger multicenter studies are needed to clarify the role of IDRFs in the choice of surgical modality. Previous retrospective studies have rarely focused on neuroblastoma with metastasis. In our research, four children with stage M underwent minimally invasive surgery to remove the primary tumor, and all achieved complete macroscopic resection. Some institutions believe that the presence of metastasis in other parts of the tumor is not the best indication for minimally invasive surgery [24]. We think this is unreasonable. In some aspects, minimally invasive surgery seems to be more suitable for children with tumor metastasis. At present, for NB tumors in M and Ms stages, the effect of surgical resection of the primary tumor on the survival of children is not clear [28-30], which often depends on the control degree of the metastatic site of the tumor and the situation of N-MYCN gene [29]. Therefore, for children with other sites of metastasis, the speed and intensity of chemotherapy initiation are more important. Research has confirmed that the use of minimally invasive surgery to remove tumors can make children start other treatment modes earlier, such as chemotherapy [9]. Minimize the time of chemotherapy interruption, and maintain the intensity and speed of treatment. This is extremely important in children with stage M [23]. Therefore, we believe that even for children with distant metastasis of tumors, the number of IDRFs and the size of the tumor should be evaluated according to the imaging of the primary tumor before surgery to choose a reasonable surgical method. We divided children with stage M into M1 and M2 according to the number of IDRFs in their primary site, which can supplement INRGSS and be beneficial to the development of MIS surgery. Although this study is a prospective study, due to the particularity of pediatric cancer disease, the selection of surgical methods could not be completely randomized. In the matching process, the absolute matching of each MIS group could not be achieved, and only the maximum degree of propensity matching could be performed. In addition, there were too few types of IDRFs in the minimally invasive surgery group to study the role of each IDRF in the selection of surgical methods. In the future, larger multicenter prospective studies and multivariate analysis are needed to thoroughly clarify the influence of surgical methods on children and the uniform indications for the selection of surgical methods. CONCLUSIONS This study suggests that minimally invasive surgical resection of the primary tumor is safe and feasible in children with NB. Minimally invasive surgery has no negative effect on the postoperative survival rate of children with NB. In a certain range, minimally invasive surgery has more advantages than open surgery. MIS should be the first choice for children with this range after the indications for minimally invasive surgery are gradually improved. Conflict of Interest statement： None of the authors have a conflict of interest to disclose. Acknowledgements： We are grateful to Professor Ye Tao for the statistical evaluation. References 1. Katherine K. Matthay, Harland N. Sather, Robert C. Seeger et al. 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Englum BR, Rialon KL, Speicher PJ et al. Value of surgical resection in children with high-risk neuroblastoma. Pediatric Blood Cancer, 2015;62(9): 1529-1535. Legends: Figure. 1. Consort diagram Figure. 2. Laparoscopic left adrenal region NB resection: (A, B) Separate and expose about 1-2cm of the left adrenal vein, and cut the left adrenal vein after clamping with hem-o-lock; (C, D) Completely separate the adrenal tumor from the kidney with the ultrasonic scalpel bluntly or sharply. Figure. 3. Laparoscopic right adrenal region NB resection: (A, B) Separate adrenal glands and tumors along the plane of the psoas major muscle. Figure. 4. Laparoscopic removal of enlarged lymph nodes in the renal hilum：(A, B) Renal arteries and veins are pulled with traction belts respectively before the enlarged lymph nodes are removed. Figure. 5. No significant statistical difference in the postoperative overall survival rate between the two groups of children. Table 1. Comparison of the clinical data of the two groups of patients Table 2. Comparison of the Surgical outcomes and survival outcomes of the two groups of patients. Supplementary Material File (table 1 comparison of the clinical data of the two groups of patients.docx) Download 13.66 KB File (table 2 comparison of the surgical outcomes and survival outcomes of the two groups of patients.docx) Download 12.56 KB Information & Authors Information Version history V1 Version 1 25 March 2024 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords late effects of cancer treatment neuroblastoma surgery Authors Affiliations Zhang Jun [email protected] Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Lan Qin Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Zhenzhen Zhao Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author XiangRu Kong Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Yonggang Li Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Chao Yang Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Xiaobing Deng Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Liang Peng Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author LinYa Lv Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author ChangChun Li Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Shan Wang 0000-0002-4562-2247 Department of Surgical Oncology Children’s Hospital of Chongqing Medical University National Clinical Research Center for Child Health and Disorders Ministry of Education Key Laboratory of Child Development and Disorders Chongqing Key Laboratory of Child Rare Diseases in Infection and Immunity View all articles by this author Metrics & Citations Metrics Article Usage 310 views 137 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Zhang Jun, Lan Qin, Zhenzhen Zhao, et al. Comparative Effectiveness of Minimally Invasive Surgery vs Open Surgery in neuroblastoma. Authorea . 25 March 2024. DOI: https://doi.org/10.22541/au.171133818.81168488/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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