1.Drug-eluting bead TACE combined with apatinib and camrelizumab for treating massive hepatocellular carcinoma
Jinwei CHEN ; Jianzhuang REN ; Xuhua DUAN ; Pengfei CHEN ; Xingshu ZHU
Chinese Journal of Interventional Imaging and Therapy 2024;21(2):65-69
Objective To observe the value of drug-eluting bead TACE(D-TACE)combined with apatinib and camrelizumab for treating massive hepatocellular carcinoma(HCC).Methods Data of 35 patients with massive HCC who underwent D-TACE sequential apatinib and camrelizumab were retrospectively analyzed.The overall survival(OS)and progression free survival(PFS)were recorded,and the objective response rate(ORR),disease control rate(DCR)and treatment-related adverse event(TRAE)were evaluated.Results Combination treatment were all successfully performed in all 35 cases.At the last follow-up,the median PFS was 8.09 months,and the median OS was 20.00 months.One,3,6,and 12 months after treatments,ORR was 65.71%(23/35),71.43%(25/35),65.71%(23/35)and 60.71%(17/28),respectively,DCR was 94.29%(33/35),88.57%(31/35),80.00%(28/35)and 67.86%(19/28),respectively.TRAE of combination treatment mainly ranged from grade 1 to 2,and all relieved after symptomatic treatments.Conclusion D-TACE combined with apatinib and camrelizumab was effective and safe for treating massive HCC,with controllable adverse reactions.
2.Effect of TACE with drug-loaded microspheres versus with iodinated oil emulsion on liver fibrosis
Daqian HAN ; Hao LI ; Manzhou WANG ; Chao LIANG ; Jiacheng WANG ; Wenze XU ; Yangyang NIU ; Donglin KUANG ; Jianzhuang REN ; Xuhua DUAN
Chinese Journal of Hepatobiliary Surgery 2024;30(10):738-743
Objective:To compare the effects of drug-loaded microsphere TACE (D-TACE) and iodinated oil emulsion TACE (cTACE) on liver fibrosis in the treatment of advanced hepatocellular carcinoma (HCC).Methods:Clinical data of 113 patients with HCC treated with D-TACE or cTACE at the First Affiliated Hospital of Zhengzhou University from October 2019 to September 2020 were retrospectively analyzed, including 96 males and 17 females, aged (56.8±9.8) years old. According to treatment protocol, patients were divided into two groups: the D-TACE group ( n=57) and the cTACE group ( n=56). Liver fibrosis panel, fibrosis index (FIB-4), aspartate aminotransferase to platelet ratio index (APRI), and liver stiffness measurement (LSM) were compared between the groups at four timepoints: pre-treatment, one month after the first TACE, one month after the second TACE, and 12 months after the first TACE. Follow-ups were conducted through outpatient visits or telephone reviews to assess patient survivals. Data including the progression-free survival (PFS) and number of TACE sessions were compared between the two groups. Results:The D-TACE group received 2.84±1.12 sessions of treatment during the observation period, compared to 4.05±1.44 sessions of cTACE group ( t=4.94, P<0.001). The median PFS in D-TACE and cTACE groups were 10.0 and 5.0 months, respectively ( P<0.001). At one month after the second TACE and at 12 months after the first TACE, patients in cTACE group had a higher serum levels of fibrosis markers including hyaluronic acid, type IV collagen, type III procollagen N peptide and laminin than those in D-TACE group (all P<0.05). At the same timepoints, patients in cTACE group also had higher APRI, FIB-4 and LSM than those in D-TACE group (all P<0.05). Conclusion:Compared to cTACE, patients in D-TACE group received fewer sessions of treatment during the first year after initial TACE, and the degree of liver fibrosis was also lower in D-TACE group.
3.Efficacy and safety of 125I intraluminal irradiation combined with lenvatinib in treatment of progressive extrahepatic cholangiocarcinoma
Xingshu ZHU ; Pengfei CHEN ; Mengfan ZHANG ; Fangzheng LI ; Jinwei CHEN ; Wenguang ZHANG ; Xuhua DUAN ; Jianzhuang REN ; Xinwei HAN
Journal of Clinical Hepatology 2023;39(10):2406-2412
ObjectiveTo investigate the efficacy and safety of 125I intraluminal irradiation combined with lenvatinib in the treatment of progressive extrahepatic cholangiocarcinoma. MethodsA retrospective analysis was performed for 25 patients with progressive extrahepatic cholangiocarcinoma who attended Department of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, from January 2018 to November 2021, and according to the treatment modality, they were divided into combination group with 13 patients (125I intraluminal irradiation combined with lenvatinib) and control group (125I intraluminal irradiation alone). The two groups were compared in terms of technical success rates, changes in liver function, stent patency, survival time, and incidence rates of adverse events. The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Wilcoxon rank-sum test was used for comparison of continuous data with skewed distribution between two groups; the Fisher’s exact test was used for comparison of categorical data between groups. The Kaplan-Meier method and the log-rank test were used to evaluate survival time and stent patency. ResultsAll patients had successful implantation of biliary stents and 125I particles, with a technical success rate of 100%. After 1 month of treatment, both groups had significant improvements in the serum levels of total bilirubin, direct bilirubin, alanine aminotransferase, and aspartate aminotransferase (all P<0.05). There were significant differences between the control group and the combination group in the duration of stent patency (7.0 months vs 9.5 months, P=0.022) and median survival time (11.5 months vs 15.6 months, P=0.008). There were no intolerable adverse events in the combination group during treatment. ConclusionCompared with 125I intraluminal irradiation alone, 125I intraluminal irradiation combined with lenvatinib has better efficacy and is a safe and effective treatment regimen for progressive extrahepatic cholangiocarcinoma.
4.3D printed template assisted pre-fenestration of stent graft with reducing-diameter tie technique for complex abdominal aortic diseases
Wenguang ZHANG ; Zhanguo SUN ; Jianzhuang REN ; Mengfan ZHANG ; Pengfei CHEN ; Pengwei YANG ; Baoshou WANG ; Pengli ZHOU ; Xinwei HAN
Chinese Journal of General Surgery 2023;38(1):23-27
Methods:From Jan 2019 to Nov 2021, 20 patients underwent 3D printed template assisted pre-fenestration of stent graft with reducing-diameter tie technique and branched stents for the EVAR at the three hospitals. The clinical data patients were collected and analyzed.Results:All the 20 cases underwent 3D printed template assisted pre-fenestration of stent graft according to the data of pre-operative the computed tomographic angiography (CTA). EVAR was successfully performed in all patients(included 2 cases with one fenestration,5 cases with 2 fenestration,10 cases with 3 fenestration and 3 cases with 4 fenestration). Fifty-four reinforced fenestrations (20 in right renal artery, 18 in left renal artery, 13 in superior mesenteric artery and 3 in celiac artery) were performed. During the follow-up period (mean 14.6 months), 1 case died, and the one-stage patency rate of splanchnic artery branch stent was 98.1%. Four patients had endoleak, 1 patient died of intracranial hemorrhage during postoperative period. None of patients had postoperative paraplegia or organ ischemia.Conclusions:3D printed template assisted pre-fenestration of stent graft with reducing-diameter tie technique is feasible for EVAR in the treatment of complex abdominal aortic aneurysms and dissections. The technique is capable to reinforce the blood supply of visceral arteries with satisfied short-term effectiveness.Ojective:To evaluate 3D printed template assisted pre-fenestration of stent graft with reducing-diameter tie technique and branched stents for the endovascular aortic aneurysm repair (EVAR).
5.Safety and efficacy of camrelizumab added to second-line therapy after drug-eluting bead transarterial chemoembolization combined with apatinib for unresectable hepatocellular carcinoma
Yancang ZHANG ; Manzhou WANG ; Xinwei HAN ; Xuhua DUAN ; Jianzhuang REN ; Hao LI ; Wenhui WANG ; Wenze XU
Journal of Clinical Hepatology 2023;39(4):834-842
Objective To investigate the safety and efficacy of camrelizumab added to second-line therapy after drug- eluting bead transarterial chemoembolization (DTACE) combined with apatinib for unresectable hepatocellular carcinoma (HCC). Methods A retrospective analysis was performed for 89 HCC patients with camrelizumab added to second-line therapy who attended The First Affiliated Hospital of Zhengzhou University from December 2019 to December 2020. The primary endpoints were overall survival (OS) and progression-free survival (PFS) after the application of camrelizumab, and the secondary endpoints were objective remission rate (ORR), disease control rate (DCR), and treatment-related adverse events (TRAEs). The Kaplan-Meier method was used to plot survival curves, the Log-rank test was used for stratified analysis of subgroups based on baseline characteristics, and the influencing factors for prognosis were analyzed. Results A total of 89 patients were screened and followed up in this study. The patients were followed up to December 2021, with a median follow-up time of 16 months, a median OS time of 17.0 (95% confidence interval [ CI ]: 15.3-18.7) months, and a median PFS time of 7.0 (95% CI : 6.2-7.8) months. There were significant differences in OS and PFS between the patients with different ECOG-PS scores, liver function Child-Pugh classes, portal vein invasion, patterns of progression, times of DTACE treatment, durations of oral administration of apatinib, and durations of application of camrelizumab (all P < 0.05). At 3 and 6 months after the application of camrelizumab, ORR was 39.3% and 22.4%, respectively, and DCR was 80.9% and 54.1%, respectively. The univariate analysis using the Log-rank test showed that compared with the patients receiving 0 time of DTACE treatment, the patients receiving 3-4 or 1-2 times of DTACE treatment had significant improvements in median OS [22.0 (95% CI : 21.1-22.9) months and 17.0 (95% CI : 15.8-18.2) months vs 10.0 (95% CI : 7.0-13.0) months, χ 2 =31.423, P < 0.001] and PFS [10.0 (95% CI : 7.0-13.0) months and 7.0 (95% CI : 6.2-7.8) months vs 3.0 (95% CI : 1.9-4.1) months, χ 2 =20.741, P < 0.001]; compared with the patients using apatinib for ≤4 months, the patients using apatinib for > 4 months had significant improvements in median OS [21.0 (95% CI : 19.1-22.9) months vs 14.0 (95% CI : 10.4-17.6) months, χ 2 =19.399, P < 0.001] and PFS [9.0 (95% CI : 7.3-10.7) months vs 5.0 (95% CI : 4.0-6.0) months, χ 2 =27.733, P < 0.001]; compared with the patients using camrelizumab for ≤5 months, the patients using camrelizumab for > 5 months had significant improvements in median OS [22.0 (95% CI : 20.2-23.8) months vs 13.0 (95% CI : 9.3-16.7) months, χ 2 =22.336, P < 0.001] and PFS [9.0 (95% CI : 7.0-11.0) months vs 5.0 (95% CI : 4.1-5.9) months, χ 2 =26.141, P < 0.001]. Post-embolization syndrome was the adverse event after DTACE and resolved after symptomatic treatment. Adverse reactions related to targeted drugs and immunotherapy all resolved after symptomatic supportive treatment, with no grade ≥4 adverse reactions, and no patients withdrew from target-free therapy due to TRAEs. Conclusion As for DTACE combined with apatinib in the treatment of unresectable HCC, camrelizumab added after progression has a marked therapeutic efficacy with safe and controllable TRAEs.
6.The efficacy and safety of a novel domestic pulmonary artery thromoectomy system in the treatment of acute pulmonary embolization
Wenguang ZHANG ; Pengfei CHEN ; Mengfan ZHANG ; Hong LIU ; Shaoxia LIU ; Haibo YANG ; Yan SONG ; Deguang FENG ; Jianzhuang REN ; Xinwei HAN
Chinese Journal of Radiology 2023;57(10):1100-1105
Objective:To evaluate the efficacy and safety of a novel domestic pulmonary thromoboectomy system Tendvia TM in the treatment for high-risk patients complicated with acute pulmonary embolization (APE). Methods:The study was designed as a prospective single-center clinical trial. Twenty-four high-risk patients with APE were recruited and underwent percutaneous mechanical thromoectomy (PMT) with the Tendvia TM pulmonary thromoboectomy system. The primary efficacy endpoint was the reduction of RV/LV ratio at the post-operative 48 h. The secondary efficacy endpoints included technical success rate, mean pulmonary arterial pressure (mPAP), arterial PaO 2 and the instant post-operative thrombus clearance rate. The evaluation of the safety included the intraoperative complications and related complications during the follow-up period associated with the PMT operation and the major adverse event (MAE) rate within the post-operative 48 h. The pre-and post-operative data were compared with paired sample t-test or Wilcoxon rank sum test to evaluate the efficacy and safety of Tendvia TM pulmonary thromoboectomy system. Results:The technical success rate of PMT with Tendvia TM pulmonary thromoboectomy system was 100% (24/24). The 48 h pre-operative RV/LV ratio was 1.19±0.25 and the post-operative RV/LV ratio was 0.82±0.16. The mean RV/LV ratio of the patients was decreased by 0.37±0.25 at post-operative 48 h with significant statistical difference ( t=7.03, P<0.001). The 48 h pre-operative mPAP was (31.09±6.09) mmHg and the post-operative mPAP was (25.91±4.36) mmHg. The mPAP of the patients was reduced by 5.18 mmHg at post-operative 48 h with significant statistical difference ( t=6.73, P<0.001). The pre-operative PaO 2 was (74.66±11.28) mmHg and the post-operative PaO 2 was (88.01±10.57) mmHg. The pressure of oxygen in artery was increased by 13.36 mmHg. The differences were statistically significant( t=-4.08, P<0.001). The rate of thrombus removal was 68.17%±22.66%. 87.5% (21 cases) of patients achieved a thrombus removal greater than grade Ⅱ. One patient underwent catheter directed thrombolysis (CDT) after PMT based on the evaluation of operator. The patient′s thrombus removal achieved grade Ⅲ after 48 h and the CDT was ceased. Hemoptysis occurred intra-operatively in one case underwent PMT and the symptom of the patient was alleviated with conservative medication. The MAE incidence within the post-operative 48 h was 4.17% (1/24). No device-related mortality or all-cause mortality occurred in the trial. Conclusions:The Tendvia TM pulmonary thromoboectomy system is a safe and effective device to remove the pulmonary arterial thrombus for the treatment of patients with APE. The Tendvia TM pulmonary thromoboectomy system can be a new choice in the treatment for the patients with APE.
7.Clinical efficacy of transjugular intrahepatic portosystemic shunt for gastrointestinal hemorrhage in patients with idiopathic noncirrhotic portal hypertension
Wenguang ZHANG ; Jianzhuang REN ; Tao WEI ; Yaopu WANG ; Jinfeng XUE ; Pengfei CHEN ; Xueliang ZHOU ; Xinwei HAN
Chinese Journal of Internal Medicine 2022;61(5):548-551
Objective:To explore the medium-long term efficacy of transjugular intrahepatic portosystemic shunt (TIPS) for gastrointestinal hemorrhage in patients with idiopathic non-cirrhotic portal hypertension (INCPH).Methods:From March 2013 to July 2018, clinical data of 13 INCPH patients, including 5 males, 8 females,with gastrointestinal hemorrhage were retrospectively analyzed, who were diagnosed at the First Affiliated Hospital of Zhengzhou University, Anyang Fifth People′ s Hospital and Yuncheng Central Hospital. All patients received TIPS treatment. The general information, postoperative survival rate, the incidence of rebleeding, shunt dysfunction rate, and incidence of hepatic encephalopathy were analyzed.Results:All 13 patients with INCPH completed TIPS successfully with an average age of 45±8 (33 to 59) years. The hepatic venous pressure gradient (HVPG) decreased from 20.0-26.0 (22.6±1.9) mmHg before procedure to 8.0-14.0 (9.4±3.2) mmHg after. The median follow-up time was 44±7 (31 to 53) months. One patient died of liver failure 27 months after TIPS. Hepatic encephalopathy occurred cumulatively in 1 case (1/13), 1 case (1/13) and 1 case (1/13) in 12, 24 and 36 months after TIPS. Stent restenosis occurred cumulatively in 2 cases (2/13), 3 cases (3/13) and 3 cases (3/13) in 12, 24 and 36 months after TIPS. Portal vein thrombosis occurred cumulatively in 2 cases (2/13), and no primary liver cancer developed.Conclusions:TIPS is safe and effective in the treatment of INCPH with gastrointestinal bleeding with favorable medium-long term outcome.
8.The application of transjugular liver biopsy in patients with unexplained liver disease
Wenguang ZHANG ; Xianwei QI ; Jingqiang ZHANG ; Zhenhua TIAN ; Pengfei CHEN ; Xueliang ZHOU ; Fangzheng LI ; Yong NIU ; Jianzhuang REN ; Xinwei HAN
Chinese Journal of Hepatobiliary Surgery 2022;28(9):651-655
Objective:To investigate the clinical value of transjugular liver biopsy (TJLB) in patients with unexplained liver disease complicated with massive ascites or coagulopathy.Methods:A retrospective analysis was performed from patients underwent TJLB in the First Affiliated Hospital of Zhengzhou University, Zhoukou Central Hospital, Shangqiu First People's Hospital and Jincheng People's Hospital from March 2015 to January 2022 due to unexplained liver disease complicated with massive ascites or coagulopathy. A total of 37 patients were included, including 21 males and 16 females, aged (53.5±11.9) years. According to different puncture points, the patients were divided into two groups: transhepatic right vein TJBL and transhepatic middle vein TJBL. The obtained liver tissue sampling effect, puncture times, complications were analyzed.Results:The success rate of TJLB was 97.3%(36/37). Thirty-six patients were able to obtain more than three segments of liver tissue and obtain histological diagnosis, and the pathological diagnosis rate was 100.0%(36/36). The number of puncture times, the amount of hepatic tissue and the number of portal areas in the right hepatic vein group (21 cases) were (3.7±0.9), (3.7±0.7) and (6.5±0.9) respectively, and those in the middle hepatic vein group (15 cases) were (3.7±0.7), (3.7±0.7) and (6.3±0.8) respectively. There were no significant differences between the two groups (all P>0.05). Conclusion:TJLB is safe and feasible for patients with unexplained liver disease complicated with massive peritoneal effusion and coagulopathy. Good liver tissue specimens can be obtained by TJLB from both right hepatic vein and middle hepatic vein.
9.Dynamic observation of degradation property of novel magnesium alloy stents in Bama mini-pig models of carotid artery stenosis by high-resolution C-arm CT: a feasibility study
Tengfei LI ; Sun YU ; Chengcheng SHI ; Shuhai LONG ; Ji MA ; Zhen LI ; Jianzhuang REN ; Xinwei HAN
Chinese Journal of Neuromedicine 2022;21(12):1189-1194
Objective:To explore the degradation property of novel magnesium alloy stents in Bama mini-pig models of carotid artery stenosis, and evaluate the feasibility of observing their dynamic and continuous process by high-resolution C-arm CT.Methods:Twelve Bama mini-pigs were selected; carotid artery stenosis models were established by large balloon over-dilation and high-fat and high-salt diet in Bama pigs; 24 weeks after that, self-made braided degradable magnesium alloy stents were inserted into the carotid artery stenosis models (confirmed by DSA) by balloon dilation. Degrees of stent patency and in-stent restenosis were examined by DSA immediately after procedure and on the 30 th, 60 th and 90 th d of procedure. Four experimental pigs were sacrificed on the 30 th, 60 th and 90 th d of procedure, respectively; the degradation property of the novel magnesium alloy stents was observed according to results of high-resolution C-arm CT in the inserted-stent areas and staining results of specimens in the stenosis areas, and stent imaging features during degradation were summarized. Results:Twelve Bama mini-pig models of carotid artery stenosis were established and 12 magnesium alloy stents were successfully inserted with a technical success rate of 100%. Both immediate postoperative and follow-up angiography showed patency of the vascular lumens without obvious in-stent restenosis. High-resolution C-arm CT and pathological examination showed homogeneous stent lumens and clear delineation of the stent meshes, with slightly degraded stent on the 30 th d of procedure; the stent lumen was blurred and some magnesium alloy wires were fractured with developed degradation of the stent on the 60 th d of procedure; and the stent meshes and stent strut could not be visualized due to severe degradation of the stent on the 90 th d of procedure. Conclusion:Magnesium alloy degradable stent is almost completely degraded within 90 th d of procedure in Bama mini-pig models of carotid artery stenosis, and high-resolution C-arm CT can be used to dynamically monitor the degradation of the stent in vivo.
10.A cost-effect analysis of transarterial chemoembolization with CalliSpheres beads loaded with arsenic trioxide versus arsenic trioxide iodized oil emulsion in treatment of unresectable liver cancer
Wenhui WANG ; Xuhua DUAN ; Hao LI ; Shuguang JU ; Manzhou WANG ; Jianzhuang REN ; Xinwei HAN
Journal of Clinical Hepatology 2021;37(9):2125-2129
Objective To investigate the cost-effect of transarterial chemoembolization (TACE) with CalliSpheres beads loaded with arsenic trioxide (ATO) (CBATO) versus ATO iodized oil emulsion (conventional TACE, cTACE) in the treatment of unresectable liver cancer. Methods A total of 100 patients with advanced liver cancer who attended The First Affiliated Hospital of Zhengzhou University from May 2017 to December 2018 were enrolled and divided into CBATO group( n =45) and cTACE group( n =55) according to the treatment regimen. Progression-free survival (PFS) was used to evaluate the efficacy of quality-adjusted life year (QALY), and European Quality of Life-5 Dimensions (EQ-5D) index was used to evaluate quality of life. The t -test was used for comparison of continuous data between groups, and the chi-square test was used for comparison of categorical data between groups; the number of surgeries, length of hospital stay, treatment cost, and incremental cost-effectiveness ratio (ICER) were calculated for the two groups, and then a cost-effect analysis was performed. Results Within the PFS time, the per capita hospital cost was 96 446 yuan in the CBATO group and 91 230.43 yuan in the cTACE group. There were significant differences between the two groups in the mean number of surgeries (2.5±0.7 vs 3.4±0.8, t =16.911, P < 0.01) and mean hospital stay (5.8±1.2 days vs 7.5±1.8 days, t =12.459, P < 0.01). The CBATO group had a significantly higher QALY than the cTACE group (0.804 vs 0.512). Compared with the cTACE group, the CBATO group had an ICER of 17 861.53 yuan/QALY for unresectable liver cancer. Conclusion Although CBATO has a higher surgery cost than cTACE, CBATO has a better clinical effect than cTACE and can reduce the number of surgeries and length of hospital stay, with a better postoperative quality of life than cTACE, suggesting that CBATO has marked cost-effect advantages.

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