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Experimental And Clinical Study Of Domestic Medical Adhesive In Interventional Therapy Of Artery Hemorrhagic Disease

Posted on:2020-10-08Degree:DoctorType:Dissertation
Country:ChinaCandidate:M XuFull Text:PDF
GTID:1484306308985429Subject:Medical imaging and nuclear medicine
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Artery injury hemorrhage is a common clinical disease and can be caused by trauma,Surgical surgery or complication of intervention and spontaneous artery rupture.Conservative treatment can be carried out for self-healing in mild cases,but timely surgical treatment is recommended for severe cases.Traditional surgical treatment methods were incision and repair of organs,ligation of bleeding artery and nephrectomy,however they were not accepted by doctors and patients because of serious trauma,high risk and impairment of organ function.Transcatheter embolization of peripheral artery for hemorrhagic has successfully solved the above problems and achieved good therapeutic effects due to its minimally invasive,good effect and maximum protection of organ function and it has become the first choice for artery hemostasis.The appropriate application of embolic materials is crucial for hemostasis,which is generally determined by factors such as etiology,vascular anatomy,availability of the embolic agent,and personal preference of the operator.The solid embolic agents,such as spring coil and gelatin sponge particles,are commonly used in embolization of renal artery.Coil embolization depends on the ability of the patient to form thrombus;Coagulopathic states such as thrombocytopenia,platelet dysfunction,and abnormal clotting factors may hinder complete vessel occlusion.The use of multiple coils may significantly increase the cost of the procedure.In the renal setting,control of the distribution of Gelfoam can be difficult and it can be re-absorption and hemostasis depends on coagulation function like the coils.N-Butyl Cyanoacrylate(NBCA),as a liquid embolic agent,has the characteristics of not being affected by coagulation function,strong controllability,good vascular conformability,instant permanent embolization,and makes up for the deficiency of solid embolism in the transcatheter embolization of renal artery for hemorrhagic.However,NBCA,as an imported medical adhesive,is not only expensive,but also the solvent has vascular toxicity and requires special catheter,which limits its clinical application.Domestic medical adhesive has similar characteristics to NBCA.It is nontoxic,does not need a special catheter,has low price and easy to obtain as a domestic medical glue.However,its instructions do not mention the utility and safety in interventional therapy.For the above problems,some research of animal and clinical experiments were choosed to study the feasibility and safety of renal artery embolization with domestic medical adhesive and providing basis for rational selection of clinical application.Part 1 Feasibility study of rabbit renal artery embolization withDomestic Medical AdhesiveObjective:To sutdy the feasibility and safety of the rabbit renal artery embolization with domestic medical adhesive and lipiodol mixture by animal experiments.The concentration of different embolic agents that influence the process and the effect of embolization were observed in order to lay the groundwork for clinical application.Materials and methods:120 healthy rabbits were randomly divided into 3 groups with 40 rabbits per group.A mixture of different ratios of lipiodol:domestic medical adhesive(5:1?4:1?3:1)were prepared.After the administration of general anesthesia and fixture the right femoral artery was punctured and cannulated to the side of renal artery.The embolic agent was slowly injected into the renal artery under the strict fluoroscopy,significantly slowing down blood flow to the termination,then re-angiography to observe the results of embolization.Rabbits in each group were executed at different times after embolization.Acute group were killed 24 hours after embolization with no re-angiography,Angiogrpahic evaluation were made at 7 days?30 days after the embolization procedure in the sub-acute and chronic groups to review of whether the observed vasculars were recanalized.Then all the rabbits were sacrificed and histological evaluation of the embolized kidneys was performed.Hematological and biochemical evaluation(including hepatic and renal function and blood routine)were compared before and after embolization.Results:Five rabbits died(add 5 rabbits to the experiment)of excessive anesthesia,failure of femoral artery separation and cannulation,embolic agents refluxing,sticking to cathete and ectopic embolization.After improving the experimental techniques there was no recurrence of the above situation.Embolic agents can be seen under the fluoroscopy,easy to control and inject transcatheter,also can be repeated injected by one micro-catheter with safety and effectiveness.Angiography review of sub-acute and chronic phase showed a reliable embolization,no vascular recanalization and no spillover of contrast agent.There was no significant difference of renal tissue degeneration and necrosis among the 3 groups(P>0.05).Postoperative renal function was transient damage,leukocyte was a transient increaseing.Optical microscope examination after HE staining showed irregular-shaped embolic agents or branch-like refractive index of transparent material can be seen in the embolized artery.In the 5:1 group and 4:1 group,arteriole and small artery were mainly embolized,there was no significant difference between the two groups(P>0.05);Whereas medium-sized artery was mainly embolized in the 3:1 group,compared with the 5:1 group and 4:1 group there were significantly different(P<0.05).Renal vasodilator,congestition,mild inflammatory cell infiltration and renal tissue degeneration can be seen during acute stage,but no significant coagulation necrosis and fibrous tissue hyperplasia.Endovascular embolization agents still exist during sub-acute and chronic phase,there were coagulation necrosis,calcification in the corresponding segments of renal tissue.A wide range of inflammatory cell infiltration and fibrous tissue proliferation can be seen around the necrotic tissue.Conclusion:It is feasible,safe and effective for domestic medical adhesive to embolize rabbit renal artery,the different concentration of the embolic agent can embolize the different branches of rabbit renal renal artery.It is worthy to have a further investigation and clinical trial.Part 2 Application of Transcatheter Arterial Embolization of Arterial Gastrointestinal Hemorrhage Embolization with Domestic Medical AdhesiveObjective:To investigate the clinical safety and effectiveness of domestic medical adhesive with superselective catheterization in endovascular embolotherapy for the treatment of internal medicine and gastroscopy-invalid gastrointestinal hemorrhage(GIH).Methods:the clinical data of a total of 25 GIH patients,confirmed by angiography while gained invalid results after internal medicine or gastroscopy from Oct.2016 to May 2019,were retrospectively analyzed.The mixture of lipiodol and domestic medical adhesive(1:1)was used to embolized the bleeding vessel.The follow-up compared and analyzed the operation time,domestic medical adhesive amount,technical success rate,clinical success rate,postoperative complications,and survival conditions.Results:among the 25 GIH patients,23 cases were singly applied domestic medical adhesive,and two cases were applied microcoil+domestic medical adhesive;all the patients were successfully performed hemostasis with the hemostasis success rate as 100%.Two patients with embolotherapy relapsed bleeding within 30 days,but were performed successful hemostasis using domestic medical adhesive;four patients died during follow-up,and three patients with advanced cancer progressed to cachetic failure and died;one death case was caused by severe necrotizing pancreatitis induced severe infection.Three patients occurred postoperative intestinal ischemic symptoms,among who 2 patients relieved by themselves and one patient's abdominal pain aggravated progressively,which was resected surgically and confirmed to be colonic neoplasms,and the intraoperative view revealed obvious ischemia of local normal bowel near the tumor,but the patient finally healed and was discharged after surgery.The rest patients exhibited good survival during the postoperative follow-up.Conclusions:domestic medical adhesive embolotherapy has higher success rate toward internal medicine and gastroscopy-invalid atrial GIH while lower postoperative bleeding and complications,so its cost-efficacy is higher.Part 3 Application of Transcatheter Arterial Embolization of Traumatic Hemorrhage Embolization with Domestic Medical AdhesiveObjective:Our objective was to review the feasibility and clinical outcomes of transcatheter embolization of traumatic hemorrhage with domestic medical adhesive.Materials and methods:44 consecutive traumatic hemorrhage patients underwent domestic medical adhesive embolization between August 2016 and June 2019,hepatic artery rupture(n=17),renal artery hemorrhage(n=14)and femoral/brachial artery injury(n=13).Among the hepatic arterial bleeding patients,iatrogenic hepatic arterial bleeding in 7 patients-percutaneous transhepatic cholangiography catheter drainage(n=2),liver biopsy(n=2),Surgical operation(n=3)and traumatic hepatic arterial bleeding in 1 0 patients-traffic accident injuries(n=6),falling injuries(n=3),stab wounds(n=1).The causes of renal bleeding were post biopsy(n=5),blunt trauma(n=5),percutaneous lithotripsy of kidney stones(n=3),and complication of nephrostomy(n=1).there were 13 pseudoaneurysms on the peripheral artery(femoral artery n=9,brachial artery n=4)and in femoral artery injury hemorrhage 2 cases were caused by drug abuse and the remaining 11 cases were caused by interventional operation.Super-selective transcatheter arterial embolization of hepatic bleeding artery with mixtures of domestic medical adhesive and iodized oil(1:1)was performed in all patients when we found the lesions after radiography.The technical success rate,clinical success rate,Complications were recorded.Results:The findings of radiography in 17 hepatic artery rupture patients included extravasation of contrast(n=3),pseudoaneurysm(n=6),arteriovenous fistula(n=6)and arteriovenous fistula combine with pseudoaneurysm(n=2).The rate of successful embolization was 100%during the operation(17/17),the average volume of mixtures of domestic medical adhesive and iodized oil used was 0.6ml(0.3-1.1ml)and the average operational time was 15.5 minutes(11-23 minutes)and Average cost of domestic medical adhesive for each procedure was ?479± 174.No one appearred rebleeding and no serious complications occurred after the operation during the fellow-up;Bleeding was effectively controlled with a single injection of domestic medical adhesive in renal artery hemorrhage patients.Mean volume of domestic medical adhesive mixture(domestic medical adhesive:Lipiodol,1:1)was 0.5 mL(range,0.2-0.8 mL).No reflux of the embolic agent was noted.Average cost of domestic medical adhesive for each procedure was ?414± 123.Postembolization clinical follow-up showed no evidence of recurrent hematuria,progression of hematoma,hypertension.There was no significant increase in WBC,creatinine and blood pressure after operation(P>0.05).Doppler ultrasound examinations in 13 patients demonstrated no abscess,renal parenchyma infarction,or renal artery abnormalities.13 patients included 13 pseudoaneurysms during femoral/brachial artery injury.9 femoral artery pseudoaneurysms and 4 brachial artery pseudoaneurysms were treated with mixtures of domestic medical adhesive and iodized oil(1:1)after radiography.The lesions(n=11)were cured successfully at the first operation and supplementary embolization implemented on the other 2 patients.The average volume of domestic medical adhesive used was 1.46ml(0.5-5.5ml).Ectopic embolism occurred in 1 patient through radiography after embolization,but no distal ischemia occured.There was no rebleeding and complications associated with therapy during the fellow-up(3 months).Conclusion:It is safe and effective to embolize traumatic arterial hemorrhage with domestic medical adhesive.Compared with other embolizing agents,it has the characteristics of rapidity,high success rate and low cost.
Keywords/Search Tags:domestic medical adhesive, renal artery, embolization, gastrointestinal hemorrhage, embolism, complications, Arterial injury, Hemorrhage, Embolization
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