1.Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fracture with kyphotic deformity in the elderly (version 2024)
Jian CHEN ; Qingqing LI ; Jun GU ; Zhiyi HU ; Shujie ZHAO ; Zhenfei HUANG ; Tao JIANG ; Wei ZHOU ; Xiaojian CAO ; Yongxin REN ; Weihua CAI ; Lipeng YU ; Tao SUI ; Qian WANG ; Pengyu TANG ; Mengyuan WU ; Weihu MA ; Xuhua LU ; Hongjian LIU ; Zhongmin ZHANG ; Xiaozhong ZHOU ; Baorong HE ; Kainan LI ; Tengbo YU ; Xiaodong GUO ; Yongxiang WANG ; Yong HAI ; Jiangang SHI ; Baoshan XU ; Weishi LI ; Jinglong YAN ; Guangzhi NING ; Yongfei GUO ; Zhijun QIAO ; Feng ZHANG ; Fubing WANG ; Fuyang CHEN ; Yan JIA ; Xiaohua ZHOU ; Yuhui PENG ; Jin FAN ; Guoyong YIN
Chinese Journal of Trauma 2024;40(11):961-973
The incidence of osteoporotic thoracolumbar vertebral fracture (OTLVF) in the elderly is gradually increasing. The kyphotic deformity caused by various factors has become an important characteristic of OTLVF and has received increasing attention. Its clinical manifestations include pain, delayed nerve damage, sagittal imbalance, etc. Currently, the definition and diagnosis of OTLVF with kyphotic deformity in the elderly are still unclear. Although there are many treatment options, they are controversial. Existing guidelines or consensuses pay little attention to this type of fracture with kyphotic deformity. To this end, the Lumbar Education Working Group of the Spine Branch of the Chinese Medicine Education Association and Editorial Committee of Chinese Journal of Trauma organized the experts in the relevant fields to jointly develop Clinical guidelines for the diagnosis and treatment of osteoporotic thoracolumbar vertebral fractures with kyphotic deformity in the elderly ( version 2024), based on evidence-based medical advancements and the principles of scientificity, practicality, and advanced nature, which provided 18 recommendations to standardize the clinical diagnosis and treatment.
2.A new classification of atlas fracture based on CT reconstruction and its clinical significance
Weiyu JIANG ; Wenjie LU ; Yunlin CHEN ; Xudong HU ; Yang WANG ; Chaoyue RUAN ; Nanjian XU ; Rongming XU ; Weihu MA
Chinese Journal of Orthopaedics 2023;43(11):712-719
Objective:To investigate the clinical significance of a new classification system for atlas fractures based on pre- and post-treatment CT features, with a focus on diagnosis and treatment.Methods:A retrospective analysis was conducted on 75 cases of cervical vertebra fractures treated at the Sixth Hospital of Ningbo City between January 2015 and December 2020. The study included 44 males and 31 females, with an average age of 53.3±13.0 years (range: 27-81 years). The fractures were classified according to the Landells classification, resulting in 12 cases of type I, 13 cases of type II, 33 cases of type III, 9 cases that were difficult to classify due to fracture lines located at anatomical junctions, and 8 cases that could not be classified using the Landells classification due to diverse injury mechanisms. To establish a new preliminary classification for cervical vertebra fractures, the researchers considered whether the fracture line in the CT images involved the facet joint surface of the atlas, the impact on bilateral half-rings, and the displacement distance of the fracture ends. Five spinal surgeons were randomly selected to classify the CT images of the 75 patients using the new classification method. After one month, the imaging data of the 75 cases of cervical vertebra fractures were randomized and reclassified to assess the reliability and repeatability of the classification.Results:The new cervical vertebra fracture classification method comprised three types based on whether the fracture line involved the facet joint surface of the atlas: type A (no involvement of the facet joint surface of the atlas), type B (involvement of one side of the facet joint surface with intact contralateral half-ring), and type C (involvement of one side of the facet joint surface with fractured contralateral half-ring). Additionally, based on the maximum displacement distance between the fracture ends (>4 mm), six subtypes were identified: subtype 1 (≤4 mm displacement) and subtype 2 (>4 mm displacement). Consequently, the subtypes were classified as A1, A2, B1, B2, C1, and C2. According to the new classification method, the 75 patients included 17 cases of A1, 12 cases of A2, 7 cases of B1, 13 cases of B2, 12 cases of C1, and 14 cases of C2. The classification demonstrated excellent consistency, as assessed by the five doctors, with Kappa values of 0.85 and 0.91 for reliability and repeatability, respectively. At the final follow-up, all conservatively treated patients achieved bone healing, while four surgically treated patients experienced non-union of the fracture ends but exhibited good fusion between the atlas and axis. The remaining surgically treated patients achieved bony union without complications such as loosening or fracture of internal fixation.Conclusion:The new cervical vertebra fracture classification method, based on CT imaging features, comprehensively covers common clinical cases of cervical vertebra fractures and demonstrates excellent consistency. It provides valuable clinical guidance for the diagnosis and treatment of cervical vertebra fractures.
3.Research progress in appropriate technologies of traditional Chinese medicine in the prevention and treatment of bedridden patients with urinary retention in traumatic orthopedics
Leling FENG ; Feifei JIA ; Ying YING ; Xifen YU ; Sheng CHEN ; Suqin HAN ; Weihu MA ; Xiaozhou WANG
Chinese Journal of Trauma 2022;38(7):666-670
Urinary retention is a common complication of bedridden patients in traumatic orthopedics. The severe condition can even cause permanent bladder injury and renal failure, which brings great pain and psychological pressure to patients and seriously hinders their rehabilitation. The traditional Chinese medicine appropriate technologies have the characteristics of safety, effectiveness, low cost, simplicity and easy learning and achieve good clinical effects in the prevention and treatment of bedridden patients with urinary retention in traumatic orthopaedics, including Chinese herbal medicine, acupuncture and moxibustion, massage, etc. The authors summarize the research progress in appropriate technologies of traditional Chinese medicine in the prevention and treatment of bedridden patients with urinary retention in traumatic orthopedics from aspects of action principles, operation methods and effects of acupuncture points, moxibustion therapy, manipulation therapy, external treatment of traditional Chinese medicine and acupoint injection, so as to provide a reference for further nursing research and clinical application.
4.Axis pedicle screwing assisted by intraoperative 3-D navigation versus freehand axis pedicle screwing in treatment of Hangman fracture
Xuyu LIAO ; Weihu MA ; Jianming CHEN ; Leijie ZHOU ; Liujun ZHAO ; Guanyi LIU ; Jinming HAN ; Weiyu JIANG
Chinese Journal of Orthopaedic Trauma 2022;24(11):984-991
Objective:To compare the therapeutic results between axis pedicle screwing assisted by intraoperative 3-D navigation and freehand axis pedicle screwing in the treatment of Hangman fracture.Methods:A retrospective analysis was performed of the 64 patients with Hangman fracture who had received posterior axis pedicle screwing at Department of Spinal Surgery, The Sixth Hospital of Ningbo from May 2014 to December 2019. According to the placement methods of axis pedicle screws, they were divided into a navigation group ( n=34, subjected to axis pedicle screwing assisted by intraoperative 3-D navigation) and a freehand group ( n=30, subjected to freehand axis pedicle screwing). Pedicle screw placement time, operation time, intraoperative bleeding, fluoroscopy time, hospital stay, total hospitalization cost and complications were recorded and compared between the 2 groups. The accuracy of axis pedicle screw placement was evaluated according to the postoperative cervical CT and screw grading criteria proposed by Park et al. At admission, 3 months postoperation, and the last follow-up, neurological function of the patients was evaluated by modified Japanese Orthopedic Association (mJOA) score, neck pain was evaluated by visual analogue scale (VAS), and C2/3 vertebral body angulation and C2 forward displacement were measured. The clinical efficacy was evaluated by Moon grading at the last follow-up. Results:The navigation group and the freehand group were comparable due to insignificant differences between them in the preoperative general data ( P>0.05). The accuracy of screw placement in the navigation group (98.2%, 54/55) was significantly higher than that in the freehand group (85.2%, 46/54) ( P<0.05). The screw placement time, operation time, fluoroscopy time and total hospitalization cost in the navigation group were significantly more than those in the freehand group ( P<0.05). Vertebral artery injury occurred in 3 cases in the freehand group. Screw loosening, screw breakage or rod breakage occurred in none of the patients after operation. There was no significant difference between the 2 groups in the intraoperative bleeding, hospital stay or follow-up time ( P>0.05). In both groups, the VAS score, mJOA score, C2/3 vertebral body angulation and C2 forward displacement were significantly improved at 3 months postoperation and the last follow-up compared with those at admission ( P<0.05), but there was no significant difference between the 2 groups in the contemporary comparisons ( P>0.05). At the last follow-up, Moon grading in the navigation group was significantly better than that in the freehand group ( P<0.05). Conclusion:In the treatment of Hangman fracture, compared with freehand screw placement, axis pedicle screwing assisted by intraoperative 3-D navigation can improve accuracy and safety of screw placement and reduce postoperative complications, leading to better clinical efficacy.
5.Epidemiological characteristics of traumatic spinal cord injury in China in 2018
Dingjun HAO ; Baorong HE ; Liang YAN ; Jinpeng DU ; Xiao QI ; Shicheng YU ; Jiaojiao ZHANG ; Wenjing ZHENG ; Rongqiang ZHANG ; Dageng HUANG ; Junsong YANG ; Ming ZHU ; Jiawei OUYANG ; He ZHAO ; Keyuan DING ; Haodong SHI ; Yang CAO ; Ying ZHANG ; Qinghua TANG ; Yuan LIU ; Zilong ZHANG ; Yuhang WANG ; Ye TIAN ; Hao CHEN ; Lulu BAI ; Heng LI ; Chenchen MU ; Youhan WANG ; Xiaohui WANG ; Chao JIANG ; Jianhua LIN ; Bin LIN ; Shunwu FAN ; Lin NIE ; Jiefu SONG ; Xun MA ; Zengwu SHAO ; Yanzheng GAO ; Zhong GUAN ; Yueming SONG ; Weihu MA ; Qixin CHEN
Chinese Journal of Trauma 2021;37(7):618-627
Objective:To analyze the incidence and epidemiological characteristics of traumatic spinal cord injury in China in 2018.Methods:Multi-stage stratified cluster sampling was used to randomly select hospitals capable of treating patients with spinal cord injury from 3 regions,9 provinces and 27 cities in China to retrospectively investigate eligible patients with traumatic spinal cord injury admitted in 2018. National and regional incidence rates were calculated. The data of cause of injury,injury level,severity of injury,segment and type of fracture,complications,death and other data were collected by medical record questionnaire,and analyzed according to geographical region,age and gender.Results:Medical records of 4,134 patients were included in this study,with a male-to-female ratio of 2.99∶1. The incidence of traumatic spinal cord injury in China in 2018 was 50.484 / 1 million (95% CI 50.122-50.846). The highest incidence in the Eastern region was 53.791 / 1 million (95% CI 53.217-54.365). In the whole country,the main causes of injury were high falls (29.58%),as well as in the Western region (40.68%),while the main causes of injury in the Eastern and Central regions were traffic injuries (31.22%,30.10%). The main injury level was cervical spinal cord in the whole country (64.49%),and the proportion of cervical spinal cord injury in the Central region was the highest (74.68%),and the proportion of lumbosacral spinal cord injury in the Western region was the highest (32.30%). The highest proportion of degree of injury was incomplete quadriplegia (55.20%),and the distribution pattern was the same in each region. A total of 65.87% of the patients were complicated with fracture or dislocation,77.95% in the Western region and only 54.77% in the Central region. In the whole country,the head was the main combined injury (37.87%),as well as in the Eastern and Central regions,while the proportion of chest combined injury in the Western region was the highest (38.57%). A total of 32.90% of the patients were complicated with respiratory complications. There were 23 patients (0.56%) died in hospital,of which 17(73.91%) died of respiratory dysfunction. Conclusions:The Eastern region of China has a high incidence of traumatic spinal cord injury. Other epidemiological features include high fall as the main cause of injury cervical spinal cord injury as the main injury level,incomplete quadriplegia as the main degree of injury,head as the main combined injury,and respiratory complications as the main complication.
6.Finite element study of anterior occipital condyle plate and screw in the treatment of upper cervical spine instability
Kairi SHI ; Yang WANG ; Haojie LI ; Yunlin CHEN ; Xudong HU ; Shuyi ZHOU ; Yujie PENG ; Weihu MA
Chinese Journal of Trauma 2021;37(11):997-1005
Objective:To explore the difference in properties of anterior occipital condyle plate screws compared with common anterior occipitalcervical fusion internal fixation.Methods:A 28-year-old healthy adult male volunteer's CT data of the occiput and neck was selected to establish finite element models:including the normal model,simple artificial vertebral fixation model(special-shaped titanium cage+clival screws),anterior occipital condyle plate and screw fixation model,and clival plate and screw fixation model,then a 50 N gravity and a torque of 1.5 N m were exerted upon the upper surface of the occipital bone to make the model produce flexion and extension,lateral bending and rotation. The motion range,internal fixation stress distribution and occipital bone stress distribution of each model under varying conditions were compared.Results:Under the conditions of flexion,extension,lateral bending and rotation,the range of motion of the normal model was 18.65°,15.35°,9.82° and 34.68°,respectively;that of the simple artificial vertebral fixation model was 3.20°,3.63°,2.94° and 3.92°,respectively;that of the clival plate and screw fixation model was 0.40°,0.50°,0.35° and 0.89°,respectively;that of the anterior occipital condylar plate and screw fixation model was 0.27°,0.33°,0.13° and 0.30°,respectively. Compared with the simple artificial vertebral fixation model,the range of motion of the clival plate and screw fixation model decreased by 87.5%,86.2%,88.1% and 77.3% in flexion,extension,lateral bending and rotation. The range of motion of the anterior occipital condylar plate and screw fixation model decreased by 91.5%,90.1%,95.6% and 92.3%,respectively. Under the conditions of flexion and extension,lateral bending and rotation,the stress peak of the simple artificial vertebral fixation model was 52.3 MPa,51.9 MPa,52.6 MPa,respectively;that of the clival plate and screw fixation was 100.1 MPa,158.1 MPa,170.6 MPa,respectively;that of the anterior occipital condylar plate and screw fixation was 114.2 MPa,62.9 MPa,132.9 MPa,respectively. Under the condition of flexion and extension,lateral bending and rotation,the stress peak of the occipital bone in the simple artificial vertebral body internal fixation model was 52.9 MPa,50.9 MPa and 62.3 MPa,respectively;that of the clival plate and screw fixation model was 19.7 MPa,55.9 MPa and 38.3 MPa,respectively;that of the anterior occipital condylar plate and screw fixation model was 37.8 MPa,15.0 MPa and 16.3 MPa,respectively. The stress in bone near the hypoglossal canal was close to 0 MPa,much smaller than the stress peak in occipital bone.Conclusion:Anterior occipital condylar plate and screw fixation in front of the special-shaped titanium cage can improve the stability of occipitocervical fusion with little effect on the occipital bone and hypoglossal canal or without obvious stress concentration,and hence is a safe and reliable anterior fixation method for upper cervical spine instability.
7.Safety of atlantoaxial transarticular screw combined with C 1 pedicle screw fixation
Dingli XU ; Weiyu JIANG ; Xudong HU ; Yunlin CHEN ; Nanjian XU ; Chaoyue RUAN ; Yang WANG ; Haojie LI ; Shuyi ZHOU ; Weihu MA
Chinese Journal of Trauma 2020;36(5):408-413
Objective:To investigate the safety of posterior atlantoaxial transarticular screw combined with atlas pedicle screw fixation in Chinese.Methods:CT data of upper cervical spine in 48 patients were collected from Ningbo No.6 Hospital, including 26 males and 22 females aged 26-58 years [(37.3±13.5)years]. All CT data was transformed into 3D dimensional model and inserted with virtual screws by Mimics 19.0. Firstly, the vertical plane P 1 and the horizontal plane P 2 of the atlas were built in those atlantoaxial models, secondly the atlantoaxial transarticular screw S 0 was inserted by Margel method, and it's insertion point was located at 3 mm lateral and 2 mm cephalad in the C 2 inferior articular process. Finally, four atlas pedicle screws were inserted at the midline of atlas lateral mass. The four screws are inserted as follows. S 1: the screw was tangent to the lateral side of the S 0 or the medial of the atlas pedicle. S 2: the screw was tangent to the lateral wall of the atlas pedicle. S 3: the screw was tangent to the upper wall of the atlas pedicle. S 4: the screw was tangent to the inferior wall of the atlas pedicle. The angles between S 1, S 2 and P 1 as the camber angle, and the angle between S 3, S 4 and P 2 as the gantry angle were measured. Then the safety range of camber angle and gantry angle were calculated, and the screw length of S 1, S 2, S 3 and S 4 was measured. In all models, the camber angle and gantry angle of the screws were adjusted an interval of 2°, the number of successful cases was calculated and the success rate of insertion was calculated. Results:All 3D models were inserted successfully. The minimum value, maximum value and safety range of the camber angle of atlas pedicle screws were (-6.7±5.2)°, (10.4± 4.3)°, (17.1±3.7)°, respectively; and of the gantry angle were (-0.5±3.5)°, (11.0±5.8)°, (11.5±4.9)°, respectively. The length of screw placement was S 1: (31.1±2.4)mm, S 2: (28.3±2.5)mm, S 3: (29.2±3.8)mm, S 4: (29.6±3.0)mm, respectively ( P<0.05). When the camber angle was from -1°to 5°, the success rate of screw placement was 87.5%; when inserting with 2° camber angle, the success rate was 100%; when the gantry angle was 5°, the success rate was 93.8%. Conclusion:The posterior atlantoaxial transarticular screw combined with atlas pedicle screw can achieve satisfy insertion length and success rate.
8.Efficacy of screw-rod fixation and fusion in revision surgery after vertebroplasty
Xudong HU ; Weihu MA ; Weiyu JIANG ; Yunlin CHEN ; Yang WANG
Chinese Journal of Trauma 2020;36(10):892-898
Objective:To investigate the efficacy of screw-rod fixation and fusion in revision surgery after percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty(PKP) for osteoporotic vertebral fractures (OVFs).Methods:A retrospective case series study was carried out on clinical data of 19 patients treated by revision surgery after PVP or PKP at Zhejiang Ningbo No.6 Hospital from January 2014 to December 2017. There were 5 males and 14 females, with age of (70.7±6.0)years (range, 58-81 years). Injured segment was located at T 9 in 1 patient, T 11 in 3, T 12 in 5, L 1 fracture in 5, L 2 in 2, L 3 in 2 and L 4 in 1. Caused for revision and operation methods were as follows, 5 patients underwent debridement, screw-rod fixation and fusion due to infection, 9 patients underwent osteotomy due to progressive kyphosis, screw-rod fixation and fusion, 5 patients underwent spinal canal decompression, screw-rod fixation and fusion due to neurological dysfunction. The operation time, intraoperative blood loss, and perioperative complications were recorded. The white blood cell (WBC), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were used to evaluate the control of infection before operation, before discharge and at postoperative 3 months. The changes in Cobb angle were measured before and after operation and at the final follow-up. The American spinal injury association (ASIA) scale, visual analog scale (VAS) and Oswestry disability index (ODI) were evaluated at the final follow-up. Results:All patients were followed up for 24-46 months [(32.7±8.3)months]. The revision operation time was 135-320 minutes [(226.3±75.6)minutes]. The intraoperative blood loss was 350-1 500 ml [(825.5±230.6)ml]. There were 1 patient with poor wound healing, 2 with pulmonary infection, and 2 with hardware loosening. The WBC, ESR and CRP decreased from preoperative (9.2±1.7)×10 9/L, (88.7±19.2)mm/h, (58.7±22.9)mg/L to (7.3±0.9)×10 9/L, (42.5±13.7)mm/h, (37.3±16.3)mg/L before discharge, and (6.6±0.7)×10 9/L, (26.8±9.5)mm/h, (17.8±8.6)mg/L at postoperative 3 months ( P<0.01). The Cobb angle improved from preoperative (29.3±5.2)° to (4.8±1.2)° ofter operation and (7.3±1.6)° at the final follow-up ( P<0.05). The patients with ASIA grade C ( n=2) and grade D ( n=1) improved to grade E, and the patients with ASIA grade C ( n=2) improved to grade D at the final follow-up. Imagines showed good bone fusion in all patients at the last follow-up. The mean VAS decreased from preoperative (7.5±0.8)points to (2.1±0.5)points at the last follow-up ( P<0.05). The ODI decreased from preoperative (60.7±15.2)% to (19.9±5.9)% at the last follow-up ( P<0.05). Conclusion:For patients with OVFs undergoing revision surgery after PVP or PKP, debridement, kyphosis correction, spinal canal decompression combined with screw-rod fixation and fusion can reduce infection, correct kyphotic deformity, improve neurological function, relieve pain and improve quality of life.
9.Total neoadjuvant therapy followed by watch and wait approach or organ preservation for MRI stratified low-risk rectal cancer: early result from a prospective, single arm trial
Lin WANG ; Yiming ZHAO ; Tingting SUN ; Yuanlian XU ; Shijie LI ; Xiaoyan ZHANG ; Yong CAI ; Yongheng LI ; Zhongwu LI ; Pengju CHEN ; Yifan PENG ; Weihu WANG ; Aiwen WU
Chinese Journal of Gastrointestinal Surgery 2020;23(3):258-265
Objective:To explore the safety and efficacy of watch and wait strategy and organ preservation surgery after total neoadjuvant treatment for MRI stratified low-risk rectal cancer.Methods:A prospective single arm phase Ⅱ trial developed at Department of Gastrointestinal Cancer, Peking University Cancer Hospital & Institute was preliminarily analyzed. Subjects were enrolled from August 2016 to January 2019. Low-risk rectal cancer with following MRI features were recruited: mid-low tumor, mrT2-3b, MRF (-), EMVI (-), CRM (-), differentiation grade 1-3. Patients received intensity-modulated radiotherapy (IMRT) 50.6 Gy/22f with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR confirmed by physical examination, rectal MRI, endoscopy, and serum CEA were recommended for watch & wait approach or local excision (LE). The main study outcomes were 2-year organ preservation rate (OPR) and sphincter preservation rate (SPR).Results:Thirty-eight patients were eligible for analysis, including 24 males and 14 females with median age of 56 years; 9 cases of mrT2 (23.7%), 14 cases of mrT3a (36.8%) and 15 cases of mrT3b (39.5%); 5 cases of well differentiated adenocarcinoma (13.2%), 32 cases of moderately differentiated adenocarcinoma (84.2%) and 1 case of mucinous adenocarcinoma (2.6%). Carcinoemobryonic antigen (CEA) was elevated before treatment in 1 case. One case (2.6%) of grade 3 radiation dermatitis occurred during IMRT; 18 cases (47.4%) occurred grade 3 to 4 adverse events during consolidation chemotherapy. After total neoadjuvant treatment, the cCR and near-cCR rates were 42.1% (16/38) and 23.7% (9/38), respectively, while non-cCR rate was 34.2% (13/38). Twenty patients (20/38, 52.6%) of cCR or near-cCR underwent watch & wait approach, with a local regrowth rate of 20% (4/20). Four patients received LE, including one salvage LE. Thirteen patients (4 were ypCR) received radical resection, including 10 cases of initial low anterior resections (LAR), 1 cases of initial abdominal perineal resection (APR) and 2 cases of salvage LAR, four patients refused operation. The median follow-up time was 23.5 (8.5-38.3) months. At the last interview of follow-up, the OPR and SPR were 52.6% (20/38) and 84.2% (32/38), respectively. Only one patient developed lung metastasis and no local recurrence occurred after radical resection or LE.Conclusion:Total neoadjuvant treatment for low-risk rectal cancer achieves high cCR/near-cCR rate, with increased probability of receiving watch and wait approach and organ preservation in this subgroup.
10.Total neoadjuvant therapy followed by watch and wait approach or organ preservation for MRI stratified low-risk rectal cancer: early result from a prospective, single arm trial
Lin WANG ; Yiming ZHAO ; Tingting SUN ; Yuanlian XU ; Shijie LI ; Xiaoyan ZHANG ; Yong CAI ; Yongheng LI ; Zhongwu LI ; Pengju CHEN ; Yifan PENG ; Weihu WANG ; Aiwen WU
Chinese Journal of Gastrointestinal Surgery 2020;23(3):258-265
Objective:To explore the safety and efficacy of watch and wait strategy and organ preservation surgery after total neoadjuvant treatment for MRI stratified low-risk rectal cancer.Methods:A prospective single arm phase Ⅱ trial developed at Department of Gastrointestinal Cancer, Peking University Cancer Hospital & Institute was preliminarily analyzed. Subjects were enrolled from August 2016 to January 2019. Low-risk rectal cancer with following MRI features were recruited: mid-low tumor, mrT2-3b, MRF (-), EMVI (-), CRM (-), differentiation grade 1-3. Patients received intensity-modulated radiotherapy (IMRT) 50.6 Gy/22f with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR confirmed by physical examination, rectal MRI, endoscopy, and serum CEA were recommended for watch & wait approach or local excision (LE). The main study outcomes were 2-year organ preservation rate (OPR) and sphincter preservation rate (SPR).Results:Thirty-eight patients were eligible for analysis, including 24 males and 14 females with median age of 56 years; 9 cases of mrT2 (23.7%), 14 cases of mrT3a (36.8%) and 15 cases of mrT3b (39.5%); 5 cases of well differentiated adenocarcinoma (13.2%), 32 cases of moderately differentiated adenocarcinoma (84.2%) and 1 case of mucinous adenocarcinoma (2.6%). Carcinoemobryonic antigen (CEA) was elevated before treatment in 1 case. One case (2.6%) of grade 3 radiation dermatitis occurred during IMRT; 18 cases (47.4%) occurred grade 3 to 4 adverse events during consolidation chemotherapy. After total neoadjuvant treatment, the cCR and near-cCR rates were 42.1% (16/38) and 23.7% (9/38), respectively, while non-cCR rate was 34.2% (13/38). Twenty patients (20/38, 52.6%) of cCR or near-cCR underwent watch & wait approach, with a local regrowth rate of 20% (4/20). Four patients received LE, including one salvage LE. Thirteen patients (4 were ypCR) received radical resection, including 10 cases of initial low anterior resections (LAR), 1 cases of initial abdominal perineal resection (APR) and 2 cases of salvage LAR, four patients refused operation. The median follow-up time was 23.5 (8.5-38.3) months. At the last interview of follow-up, the OPR and SPR were 52.6% (20/38) and 84.2% (32/38), respectively. Only one patient developed lung metastasis and no local recurrence occurred after radical resection or LE.Conclusion:Total neoadjuvant treatment for low-risk rectal cancer achieves high cCR/near-cCR rate, with increased probability of receiving watch and wait approach and organ preservation in this subgroup.

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