1.Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial
Wenbo MENG ; W. Joseph LEUNG ; Zhenyu WANG ; Qiyong LI ; Leida ZHANG ; Kai ZHANG ; Xuefeng WANG ; Meng WANG ; Qi WANG ; Yingmei SHAO ; Jijun ZHANG ; Ping YUE ; Lei ZHANG ; Kexiang ZHU ; Xiaoliang ZHU ; Hui ZHANG ; Senlin HOU ; Kailin CAI ; Hao SUN ; Ping XUE ; Wei LIU ; Haiping WANG ; Li ZHANG ; Songming DING ; Zhiqing YANG ; Ming ZHANG ; Hao WENG ; Qingyuan WU ; Bendong CHEN ; Tiemin JIANG ; Yingkai WANG ; Lichao ZHANG ; Ke WU ; Xue YANG ; Zilong WEN ; Chun LIU ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Fangzhao WANG ; Lingen ZHANG ; Mingzhen BAI ; Ningning MI ; Xianzhuo ZHANG ; Wence ZHOU ; Jinqiu YUAN ; Azumi SUZUKI ; Kiyohito TANAKA ; Jiankang LIU ; Ula NUR ; Elisabete WEIDERPASS ; Xun LI
Chinese Medical Journal 2024;137(12):1437-1446
Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.
2.Impact of autologous hematopoietic stem cell transplantation on the efficacy of CAR-T treatment of relapsed/refractory multiple myeloma
Meijing DING ; Xingxing JIE ; Hujun LI ; Zhiyi XU ; Li NIAN ; Kunming QI ; Zhiling YAN ; Feng ZHU ; Jiang CAO ; Huanxin ZHANG ; Kailin XU ; Hai CHENG ; Zhenyu LI
Chinese Journal of Internal Medicine 2024;63(6):587-592
Objective:To evaluate the effect of autologous hematopoietic stem cell transplantation (ASCT) on the treatment of relapsed/refractory multiple myeloma (RRMM) with chimeric antigen receptor T cell (CAR-T) therapy.Methods:A retrospective cohort study. The clinical data of 168 patients with RRMM who underwent CAR-T therapy at the Department of Hematology, Xuzhou Medical University Hospital from 3 January 2020 to 13 September 2022 were analyzed. Patients were classified into a transplantation group (TG; n=47) and non-transplantation group (NTG; n=121) based on whether or not they had undergone ASCT previously. The objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and the levels of CD3, CD4, CD8, CD19, CD56 and natural killer (NK) cells before CAR-T infusion were analyzed by χ2 test, Kaplan-Meier method and independent sample t-test. Results:Among 168 patients with RRMM, 98 (58.3%) were male. The median age of onset was 57 (range 30-70) years. After CAR-T therapy, the ORR of patients was 89.3% (92/103) in the NTG and 72.9% (27/73) in the TG. The ORR of the NTG was better than that of the TG ( χ2=5.71, P=0.017). After 1 year of CAR-T therapy, the ORR of the NTG was 78.1% (75/96), and that of the TG was 59.4% (19/32). The ORR of the NTG was better than that of the TG ( χ2=4.32, P=0.038). The median OS and PFS in the NTG were significantly longer than those in the TG (OS, 30 vs. 20 months; PFS, 26 vs. 12 months; both P<0.05). The CD4 level before CAR-T infusion in the TG was significantly lower than that in the NTG (25.65±13.56 vs. 32.64±17.21; t=-2.15, P=0.034), and there were no significant differences in the counts of CD3, CD8, CD19, CD56, and NK cells between the TG and NTG (all P>0.05). Conclusion:Among patients suffering from RRMM who received CAR-T therapy, patients who did not receive ASCT had significantly better outcomes than those who had received ASCT previously, which may have been related to the CD4 level before receiving CAR-T therapy.
3.Alterations in functional connectivity density resulted from mild cognitive impairment and their correlations with cognitive scores in various cognitive domains in Parkinson's disease patients
Qi WANG ; Haihua SUN ; Hengheng LIU ; Tianchi MU ; Xiaolu XU ; Lihuan LI ; Congsong DONG ; Zhenyu DAI ; Fei CHEN
Chinese Journal of Neuromedicine 2024;23(8):777-784
Objective:To explore the alterations in functional connectivity density (FCD) resulted from mild cognitive impairment (MCI) and their correlations with cognitive scores in various cognitive domains in patients with Parkinson's disease (PD).Methods:Forty-three PD patients admitted to Department of Neurology, Sixth Affiliated Hospital of Nantong University from January 2022 to April 2024 were selected and divided into PD-MCI group (MoCA scores<26) and PD with normal cognition (PD-NC) group (MoCA scores≥26) according to Montreal Cognitive Assessment (MoCA). Another 23 middle-aged and elderly healthy volunteers (HC group) matched with PD patients in age, gender and education level were recruited at the same period. Resting-state functional MRI (rs-fMRI) data were collected and whole brain FCD was calculated. Differences of clinical data, whole brain FCD, and FCD in brain regions with significantly different FCD among the 3 groups were compared. Efficiency of FCD in brain regions with significantly different FCD between PD-MCI group and PD-NC group in differentially diagnosing PD-MCI and PD-NC was analyzed by receiver operating characteristic (ROC) curve. Pearson correlation was used to the analyze the correlations of FCD in brain regions with significantly different FCD with MoCA score and cognitive scores in various cognitive domains.Results:Among the 43 patients, 23 were into the PD-MCI group and 20 into the PD-NC group. PD-MCI group had significantly lower scores in the visuospatial and executive function, abstraction, and delayed memory cognitive domains than PD-NC group ( P<0.05). Brain regions with significantly different FCD among the 3 groups were the right parahippocampal gyrus, left gyrus rectus, right rolandic operculum, left middle occipital gyrus, right precentral gyrus, left middle frontal gyrus, and left medial superior frontal gyrus. Compared with the HC group, the PD-MCI group and PD-NC group had significantly increased FCD at the right parahippocampal gyrus, left gyrus rectus and right rolandic operculum, statistically decreased FCD at the right precentral gyrus, left middle frontal gyrus, and left medial superior frontal gyrus ( P<0.05). Compared with the HC group, the PD-MCI group had significantly increased FCD at the left middle occipital gyrus ( P<0.05). Compared with the PD-NC group, the PD-MCI group had significantly decreased FCD at the right parahippocampal gyrus, and statistically increased FCD at the left middle occipital gyrus and left middle frontal gyrus ( P<0.05). Area under ROC curve (AUC) of FCD in brain regions with significantly different FCD in discriminating PD-MCI and PD-NC was 0.878, with sensitivity of 90.0% and specificity of 91.3%. FCD at right parahippocampal gyrus, left middle occipital gyrus and left middle frontal gyrus was negatively correlated with MoCA score ( P<0.05); FCD at right parahippocampal gyrus was positively correlated with cognitive scores in the visuospatial and executive function, and delayed memory domains ( P<0.05); FCD at left middle occipital gyrus was negatively correlated with cognitive scores in the executive function and visual-spatial skills, and abstraction domains ( P<0.05); FCD at the left medial frontal gyrus was negatively correlated with cognitive scores in the visuospatial and executive function, abstraction and delayed memory domains ( P<0.05). Conclusions:Abnormal FCD can be noted in some brain regions of PD patients, enjoying differences between PD-MCI patients and PD-NC patients. Combined FCD in brain regions with significantly different FCD has high value in differentially diagnosing PD-MCI and PD-NC, and FCD in brain regions with significantly different FCD is correlated with cognitive function changes in PD patients.
4.Research progress in the mechanism of stimulator of interferon genes in type 2 diabetes mellitus and its microvascular complication
Min LI ; Xiaoyan QI ; Zhenyu YANG ; Weiran YE ; Yanbo LI
Chinese Journal of Diabetes 2024;32(3):227-230
Type 2 diabetes mellitus(T2DM)is a chronic metabolic disease that can lead to the damage of multiple tissues and organs throughout the body.Stimulator of interferon genes(STING)is an endoplasmic reticulum membrane protein that acts as an indirect cytoplasmic DNA sensor.The activation of the STING signaling pathway may be involved in T2DM and its microvascular complications through various mechanisms.This article reviews the research progress in the mechanism of STING in T2DM and its microvascular complications.
5.Assessment of the correlation between liver stiffness and pathological changes in Thioacetamide-induced acute hepatitis rat models using virtual touch tissue imaging quantification technology
Qi XU ; Zezheng LIU ; Zhenyu ZOU ; Jianbi ZHU ; Huanhuan DING ; Chunchun JIN ; Xiaohui XU
Chinese Journal of Ultrasonography 2024;33(3):252-259
Objective:To investigate the correlation between liver stiffness and histopathological changes in a rat model of acute hepatitis using virtual touch tissue imaging quantification (VTIQ) technology.Methods:A total of 100 SPF-grade SD rats were randomly divided into 3 groups: control ( n=30), low-dose ( n=35), and high-dose ( n=35) groups. Acute hepatitis models were induced in the low-dose and high-dose groups using 400 mg/kg and 600 mg/kg of Thioacetamide (TAA), respectively. Liver stiffness parameters of the right median lobe and right lobe were measured using VTIQ technology, Mean-H and Mean-L represent the liver lobes with higher and lower liver stiffness measurments, respectively, while Mean represent the average of the measurements from both liver lobes. Comparative analyses of liver stiffness parameters were performed across three groups and between the two lobes of the liver. The correlations between the Mean values of liver stiffness and semi-quantitative histopathological data were investigated. Ten rats were randomly selected from each of the 3 groups to test the repeatability of VTIQ values before and after euthanasia with intraperitoneal anesthesia. Subsequently, 10 rats after euthanasia from each 3 group were randomly chosen to assess the repeatability of VTIQ measurements for inter-observer and intra-observer variabilities. Results:VTIQ results showed statistically significant differences in Mean, Mean-H, and Mean-L among the 3 groups (all P<0.01). The high-dose group had higher measurements compared to the low-dose and control groups, with significant intergroup differences (all P<0.01). Significant differences in Mean-H and Mean-L were observed between the two liver lobes in both low and high-dose groups (all P<0.01). The Mean value showed significant positive correlations with semi-quantitative histopathological data of hepatocellular edema, periportal inflammatory cell infiltration, macrophage proliferation, and bile duct proliferation ( r=0.391, 0.648, 0.577, 0.542; all P<0.01). Multivariate linear regression analysis indicated that hepatocellular edema, eosinophilic change, and bile duct proliferation significantly and positively predicted the Mean value (β=-0.278, -0.196, -0.333; all P<0.05). There were no significant differences of VTIQ measurements befor and after euthanasia (all P>0.05), with repeatability coefficients of 0.166, 0.182, 0.185 for Mean, Mean-H, and Mean-L, respectively. Post-euthanasia, inter- and intra-observer VTIQ differences remained non-significant (all P>0.05), with Mean, Mean-H, Mean-L coefficients of 0.114, 0.194, 0.165 and 0.206, 0.322, 0.268, respectively. Conclusions:VTIQ technology demonstrates potential clinical value in assessing a rat model of acute hepatitis, offering a new perspective for non-invasive evaluation of acute hepatitis. However, its clinical application requires further validation.
6.Research advances in MRI on superficial zone and its injury of articular cartilage
Zhenyu LIU ; Meiling QI ; Junping ZHEN
Chongqing Medicine 2024;53(14):2207-2211
Articular cartilage superficial zone (SFZ) is the top layer of articular cartilage and its injuries are common in clinic.Therefore its find in time and conducting the treatment can delay the progress rate of os-teoarthritis (OA) and alleviate the pain and economic burden of the patients.At present,MRI is the most sen-sitive noninvasive examination technique to evaluate articular cartilage injury.Conventional MRI is limited in the early detection of subtle degeneration before cartilage morphological changes existence,and articular carti-lage lesions can only be detected when the injury is in an irreversible stage.In recent years,with the develop-ment of high field intensity MRI techniques such as 3T and 7T,the detection of water molecules,collagen fi-bers and tissue anisotropy in cartilage has considerable advantages,which can make the quantitative analysis and functional imaging for the ultrastructure and biochemical composition changes of SFZ in articular carti-lage.This article reviews the latest research progress on diagnostic value of MRI on articular cartilage SFZ and injuries.
7.Immune cell-mediated causal relationship between plasma metabolites and knee osteoarthritis:a Mendelian randomization study
Zhenyu WANG ; Hongmei ZHANG ; Lin JING ; Qi YAN ; Jixiang TANG ; Qirui GE
Military Medical Sciences 2024;48(10):778-785
Objective To evaluate both the causal relationship between plasma metabolites and the risk of knee osteoarthritis(KOA)and the potential mediating or masking effect of immune cells using Mendelian randomization(MR)systems.Methods The GWAS data on 1400 plasma metabolites,731 immune cell traits and KOA was retrieved from the genome-wide association study(GWAS)database.Two-way MR analysis was used to evaluate the causal relationship between plasma metabolism and KOA.Two-step mediation MR analysis was conducted to evaluate immune cell traits that might have mediating or masking effects.Results After sensitivity analysis and screening,65 plasma metabolites and 35 immune cell traits were found to have causal relationships with KOA(P<0.05).Mediation analysis found that CD45RA+CD28-CD8br%CD8br had a mediating effect in the causal relationship between three metabolites(2-hydroxyhi-ppurate,X-07765,X-23739)and the risk of KOA.2-hydroxyhippurate(salicylic acid)exerted a masking effect,and the effect ratio was 0.0412.Conclusion A variety of plasma metabolites and immune cell traits are causally related to KOA,which should not be regarded as a simple degenerative joint disease.The protective effect of salicylic acid against KOA may be weakened by its role in inducing the differentiation of Treg cells,which is worthy of more studies.
8.The effect of tissue inhomogeneity correction on the accuracy of dose calculation in brachytherapy of cervical carcinoma
Junjie HAN ; Huikuan GU ; Zhenyu QI
Chinese Journal of Radiation Oncology 2024;33(11):1049-1055
Objective:To explore the impact of tissue inhomogeneity correction on the accuracy of dose calculations in brachytherapy of cervical carcinoma by comparing the results of Monte Carlo (MC) dose simulation with those (TG43 algorithm) of treatment planning system (TPS).Methods:Firstly, the 192Ir source was modeled by using a MC code specially designed for brachytherapy, called egs_brachy. The accuracy of this model was verified by comparing it with the published data. Then, 8 brachytherapy plans of cervical carcinoma were selected which completed treatment at Sun Yat-sen University Cancer Center from January 2022 to May 2023, and their CT image data and treatment parameters were exported. Relevant plan information such as the source dwell positions and their corresponding dwell times were reconstructed on the patient's individualized CT images using a self-developed program. The MC dose distributions were calculated for each case and compared with the TPS calculations. When the anterior wall of the rectum was filled with gas, the differences between MC simulation and TPS calculation were compared. Additionally, 5 different calculation ranges were set for MC simulation, and the MC simulation results of different calculation ranges were compared with the TPS's, combining with the time of MC simulation, a reasonable MC calculation range was comfirmed. Then, the scipy.stats library of Python was utilized to perform independent sample t-test on dosimetric comparison results, including D 90% of high risk clinical target volume (HR-CTV) and D max, D mean, and D 2 cm3 of organs at risk (OAR). Results:The comparison between MC calculations and TPS results showed that the CTV's D 90%, the bladder's D mean and the small intestine's D mean were all within ± 1%, except for the D max difference of approximately 3% on the anterior wall of the rectum. The 2%/2 mm gamma pass rates were all>98%. When anterior wall of the rectum filled with gas, compared with MC, TPS overestimated the anterior wall of the rectum's D 2 cm3 and D mean by approximately 6.06% ( t=-6.80, P=0.002) and 5.35% ( t=-6.57, P=0.003), respectively. When the dose calculation range of MC was consistent with that of TPS, the MC calculation result underestimated the dose distribution in water by approximately 4%. When extending the MC dose calculation range by 2 cm beyond the TPS calculation range, the dose difference between MC and TPS in homogeneous water was approximately 1%, and the calculation time was saved by at least 8 h compared to MC dose calculation based on the whole CT. Conclusion:The existing TPS TG43 algorithm can ensure that the dose calculation of cervical carcinoma meets the basic accuracy requirements of clinical practice, but tissue inhomogeneity correction is recommended to improve the accuracy of dose calculation whenever possible.
9.Propensity score matching study of outcomes of elderly patients over 80 years of age with preoperative combined type 2 diabetes mellitus following laparoscopic colorectal cancer resection
Zhenyu ZHANG ; Zhi GUO ; Yang LIU ; Hengduo QI ; Wei ZHANG ; Guangshuai LIN ; Xiaojun LI
International Journal of Surgery 2023;50(5):299-306,C1
Objective:To investigate the outcome after laparoscopic radical surgery for colorectal cancer in patients over 80 years of age with preoperative combined type 2 diabetes (T2DM).Methods:Clinical data of 919 patients who underwent colorectal cancer laparoscopic resection surgery in Shaanxi Provincial People′s Hospital from January 2015 to January 2019 were retrospectively analyzed. The propensity score matching (PSM) method was used for 1∶1 matching of gender, ASA score, preoperative serum albumin level, body mass index(BMI), preoperative haemoglobin level, clinical tumour pathology TNM staging, tumour location, other medical comorbidities and history of abdominal surgery and finally group of 104 elderly diabetic patients aged ≥80 years with combined T2DM were successfully matched with another 104 non-elderly non-diabetic patients <80 years without combined diabetes group. (1) To compare the differences in operating time, intraoperative bleeding, number of intraoperative blood transfusions, number of lymph nodes dissected, number of ICU treatments, postoperative time to exhaustion and postoperative hospital stay, and postoperative adjuvant chemotherapy between the two groups after matching. (2)To observe the difference in major postoperative complications between the two groups. (3) Patients in both groups were observed for three years post-operative survival rate during the follow-up period. SPSS 25.0 statistical software was used for data analysis. The survival analysis was carried aut by the Kaplan-Meier curve method in parallel and the Log-Rank test.Results:Both groups were balanced in terms of baseline variable after PSM ( P>0.05). There was no difference between the two groups in terms of operative time, intraoperative bleeding, number of intraoperative blood transfusions, number of lymph nodes dissected, or time to postoperative evacuation ( P>0.05). There was a statistically significant difference between two groups in the number of people admitted to the ICU for treatment ( χ2=4.04, P=0.042), and ≥80 years diabetic group was higher. The difference in the incidence of postoperative complications between the two groups was not statistically significant [34.6% (36/104) vs 25.0% (26/104), χ2=2.30, P=0.130]; according to the Clavien-Dindo classification of postoperative complications, the incidence of Clavien-Dindo grade Ⅲ complications in the group ≥80 years with diabetes mellitus were was higher than that in the group <80 years without diabetes [12.5% (13/104) vs 4.8% (5/104), χ2=3.89, P=0.049]. For local surgical complications, the incidence of postoperative anastomotic leak was significantly higher in the ≥80 years diabetic group than in the <80 years non-diabetic group ( χ2=4.70, P=0.030), and the incidence of postoperative wound infection was no statistical significance in the two group. For non-surgical local complications, there was a statistically significant difference in pulmonary infection in the ≥80 years diabetic group compared to the <80 non-diabetic group ( χ2=4.68, P=0.031) and in acute coronary syndrome ( χ2=4.02, P=0.045). Compared with the <80 years non-diabetic group, patients in the ≥80 years diabetic group had significantly longer postoperative hospital stay [(13.3±4.4)d vs (9.2±3.2) d, t=3.41, P=0.019]. The difference in adjuvant chemotherapy after surgery between the two groups was not statistically significant (67.3% vs 76.0%, χ2=1.92, P=0.166). The survival rate at 3 years after surgery was not statistically significant in both groups [68.9% vs 74.2%, χ2=4.34, P=0.085]. Conclusions:The short-term and long-term outcomes of colorectal cancer in advanced age with type 2 diabetes are satisfactory. Adequate preoperative assessment of the patient's physical condition should be carried out, close intraoperative control of blood glucose, and close postoperative monitoring and regulation of blood glucose should be performed, except for patients with severe comorbidities and coexisting diseases that cannot tolerate surgery and advanced tumours that have lost their surgical significance.
10.Clinical characteristics of choledocholithiasis combined with periampullary diverticulum and influencing factor analysis for difficult cannulation of endoscopic retrograde cholangiopan-creatography: a report of 1 920 cases
Ping YUE ; Zhenyu WANG ; Leida ZHANG ; Hao SUN ; Ping XUE ; Wei LIU ; Qi WANG ; Jijun ZHANG ; Xuefeng WANG ; Meng WANG ; Yingmei SHAO ; Kailin CAI ; Senlin HOU ; Kai ZHANG ; Qiyong LI ; Lei ZHANG ; Kexiang ZHU ; Haiping WANG ; Ming ZHANG ; Xiangyu SUN ; Zhiqing YANG ; Jie TAO ; Zilong WEN ; Qunwei WANG ; Bendong CHEN ; Yingkai WANG ; Mingning ZHAO ; Ruoyan ZHANG ; Tiemin JIANG ; Ke LIU ; Lichao ZHANG ; Kangjie CHEN ; Xiaoliang ZHU ; Hui ZHANG ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Ling'en ZHANG ; Fangzhao WANG ; Wence ZHOU ; Wenbo MENG ; Xun LI
Chinese Journal of Digestive Surgery 2023;22(1):113-121
Objective:To investigate the clinical characteristics of choledocholithiasis com-bined with periampullary diverticulum and influencing factor for difficult cannulation of endoscopic retrograde cholangiopancreatography (ERCP).Methods:The retrospective case-control study was conducted. The clinical data of 1 920 patients who underwent ERCP for choledocholithiasis in 15 medical centers, including the First Hospital of Lanzhou University, et al, from July 2015 to December 2017 were collected. There were 915 males and 1 005 females, aged (63±16)years. Of 1 920 patients, there were 228 cases with periampullary diverticulum and 1 692 cases without periampullary diverticulum. Observation indicators: (1) clinical characteristics of patients with choledocholithiasis; (2) intraoperative and postoperative situations of patients undergoing ERCP for choledocholithiasis; (3) influencing factor analysis for difficult cannulation in patients undergoing ERCP for choledocholithiasis. Measurement data with normal distribution were represented as Mean±SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range) or M( Q1, Q3), and com-parison between groups was conducted using the Wilcoxon rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. The Logistic regression model was used for univariate and multivariate analyses. Results:(1) Clinical characteristics of patients with choledocholithiasis. Age, body mass index, cases with complications as chronic obstructive pulmonary disease, diameter of common bile duct, cases with diameter of common bile duct as <8 mm, 8?12 mm, >12 mm, diameter of stone, cases with number of stones as single and multiple were (69±12)years, (23.3±3.0)kg/m 2, 16, (14±4)mm, 11, 95, 122, (12±4)mm, 89, 139 in patients with choledocholithiasis combined with periampullary diverticulum, versus (62±16)years, (23.8±2.8)kg/m 2, 67, (12±4)mm, 159, 892, 641, (10±4)mm, 817, 875 in patients with choledocholithiasis not combined with periampullary diver-ticulum, showing significant differences in the above indicators between the two groups ( t=?7.55, 2.45, χ2=4.54, t=?4.92, Z=4.66, t=?7.31, χ2=6.90, P<0.05). (2) Intraoperative and postoperative situations of patients undergoing ERCP for choledocholithiasis. The balloon expansion diameter, cases with intraoperative bleeding, cases with hemorrhage management of submucosal injection, hemostatic clip, spray hemostasis, electrocoagulation hemostasis and other treatment, cases with endoscopic plastic stent placement, cases with endoscopic nasal bile duct drainage, cases with mechanical lithotripsy, cases with stone complete clearing, cases with difficult cannulation, cases with delayed intubation, cases undergoing >5 times of cannulation attempts, cannulation time, X-ray exposure time, operation time were 10.0(range, 8.5?12.0)mm, 56, 6, 5, 43, 1, 1, 52, 177, 67, 201, 74, 38, 74, (7.4±3.1)minutes, (6±3)minutes, (46±19)minutes in patients with choledocholithiasis combined with periampullary diverticulum, versus 9.0(range, 8.0?11.0)mm, 243, 35, 14, 109, 73, 12, 230, 1 457, 167, 1 565, 395, 171, 395, (6.6±2.9)minutes, (6±5)minutes, (41±17)minutes in patients with choledocholithiasis not combined with periampullary diverticulum, showing significant differences in the above indicators between the two groups ( Z=6.31, χ2=15.90, 26.02, 13.61, 11.40, 71.51, 5.12, 9.04, 8.92, 9.04, t=?3.89, 2.67, ?3.61, P<0.05). (3) Influencing factor analysis for difficult cannulation in patients undergoing ERCP for choledocholithiasis. Results of multivariate analysis showed total bilirubin >30 umol/L, number of stones >1, combined with periampullary diverticulum were indepen-dent risk factors for difficult cannulation in patients with periampullary diverticulum who underwent ERCP for choledocholithiasis ( odds ratio=1.31, 1.48, 1.44, 95% confidence interval as 1.06?1.61, 1.20?1.84, 1.06?1.95, P<0.05). Results of further analysis showed that, of 1 920 patients undergoing ERCP for choledocholithiasis, the incidence of postoperative pancreatitis was 17.271%(81/469) and 8.132%(118/1 451) in the 469 cases with difficult cannulation and 1 451 cases without difficult cannula-tion, respectively, showing a significant difference between them ( χ2=31.86, P<0.05). In the 1 692 patients with choledocholithiasis not combined with periampullary diverticulum, the incidence of postopera-tive pancreatitis was 17.722%(70/395) and 8.250%(107/1 297) in 395 cases with difficult cannula-tion and 1 297 cases without difficult cannulation, respectively, showing a significant difference between them ( χ2=29.00, P<0.05). In the 228 patients with choledocholithiasis combined with peri-ampullary diverticulum, the incidence of postoperative pancreatitis was 14.865%(11/74) and 7.143%(11/154) in 74 cases with difficult cannulation and 154 cases without difficult cannulation, respectively, showing no significant difference between them ( χ2=3.42, P>0.05). Conclusions:Compared with patients with choledocholithiasis not combined with periampullary divertioulum, periampullary divertioulum often occurs in choledocholithiasis patients of elderly and low body mass index. The proportion of chronic obstructive pulmonary disease is high in choledocholithiasis patients with periampullary diverticulum, and the diameter of stone is large, the number of stone is more in these patients. Combined with periampullary diverticulum will increase the difficult of cannulation and the ratio of patient with mechanical lithotripsy, and reduce the ratio of patient with stone complete clearing without increasing postoperative complications of choledocholithiasis patients undergoing ERCP. Total bilirubin >30 μmol/L, number of stones >1, combined with periampullary diverticulum are independent risk factors for difficult cannulation in patients of periampullary diverticulum who underwent ERCP for choledocholithiasis.

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