| Part One: Experimental study of a novel suture clip device on endoscopic closure of large perforations in gastrointestinal tractPurpose: Perforation in gastrointestinal tract is a serious complication of endoscopic diagnosis and treatment with a high fatality rate.With the wide spread use of endoscopic screening for early cancer in gastrointestinal tract and expanded indications for therapeutic endoscopy,the incidence of iatrogenic perforation continues to increase every year.TTSC is currently the most common perforation-closure device due to its low price and simple operation.However,its closing ability is limited by the restricted opening span of its clamp valve.This part of the study intends to evaluate the feasibility and effectiveness of the novel self-design suture clip device for closing large gastrointestinal perforations through in vitro animal models.Methods: Five fresh isolated colons were obtained from domestic pigs.Two standardized linear perforations were created in each specimen using a surgical scalpel.The diameter of each perforation ranged from 3-4 cm,and the two perforations in the same colon were spaced apart at a considerable distance.There were 10 perforations in 5 models.The perforation was closed with the novel suture clip device under the endoscope.The procedure time,the number of metal clips during the operation and the success rate of closure were observed and recorded.Furthermore,the leak pressure at the closed perforation sites was measured.Result: All perforations were successfully closed using the novel suture clip device.The average procedure time was(24.30?4.42)min,the number of metal clips used during the operation was(5.10±0.99),and the average leak pressure was(28.30?9.49)mm Hg.Conclusion: The novel suture clip device can close the large perforation conveniently and reliably in the in vitro porcine model,and seems to be a promising option for closing large gastrointestinal defects.Part Two: Experimental study of a novel suture clip device on endoscopic closure of large wounds after ESDPurpose: This part of the study used live animal models to compare the effect of the novel suture clip device with purse-string suture using endoloop in closing large postoperative wounds after Endoscopic mucosal dissection(ESD),and evaluate the safety and effectiveness of the novel suture clip device.Methods: Twelve healthy female Bama pigs were randomly divided into 3 groups.ESD was performed on esophagus,stomach or rectum according to the group.Each subject had two 3-5cm ESD wounds.4 Bama pigs in the experimental group(24 wounds)were closed with the novel suture clip device,4 Bama pigs in the control group(24 wounds)were closed with purse-string suture using nylon rope,and 4 Bama pigs in the blank group(24 wounds)were left open and not closed after ESD.The ESD operation time,wound healing score,postoperative complications,preoperative and postoperative blood routine examination and body temperature fluctuations were compared among the three groups.The time and success rate of closing one wound,the number of additional metal clips used during suturing,and the rate of metal clips falling off the wound were compared between the experimental group and the control group.Endoscopic follow-ups were performed on 3 days,7 days,14 days and 28 days after operation.Animals of each group were sacrificed at the corresponding time points(n=3),and gross anatomy was performed to observe whether there were visible lesions and wound healing at the surgical site.The tissues from the wound healing area were stained with HE and MASSON to evaluate the degree of inflammation and the proliferation of collagen fibers in the healing area.Results: The ESD operations were successfully completed on all subjects.One Bama pig in the experimental group had rectal perforation during the operation.The operation time of the experimental group,control group and blank group were(14.92±11.33)min,(18.91±11.41)min and(22.33±17.36)min respectively,and the difference was not statistically significant(p > 0.05).The success rate of closing the defects for the experimental group and control group were both 100%.The experimental group had shorter closing time than the control group,which were(13.61±5.48)min and(17.36±6.83)min,respectively.The difference was statistically significant(p<0.05);The number of additional metal clips used in the experimental group was less than that in the control group,which were(2.58±1.77)and(6.00±1.14)respectively,and the difference was clearly statistically significant(p<0.01).At 3 days after operation,the wound healing score of the experimental group was(1.12±0.61),and the drop rate of metal clip was(19%±25%);the wound healing score of the control group was(1.25±0.68),and the drop rate of metal clip was(8%±13%);The wound healing score of the blank group was(0.00±0.00).The difference in wound healing scores between the three groups was clearly statistically significant(p<0.01);the difference in wound healing scores between the experimental group and the control group was not statistically significant(p>0.05);the drop rate of metal clip was higher in the experimental group than that in the control group,and the difference was statistically significant(p<0.05).At 7 days after operation,the wound healing score of the experimental group was(1.83±0.62),and the drop rate of metal clip was(51%±32%);the wound healing score of the control group was(1.89±0.68),and the drop rate of metal clip was(51%±39%);The wound healing score of the blank group was(1.11±0.47).The difference in wound healing scores between the three groups was clearly statistically significant(p<0.01);there was no statistically significant difference in wound healing scores and drop rate of metal clip between the experimental group and the control group(p>0.05).At 14 days after operation,the wound healing score of the experimental group was(2.58±0.67),and the drop rate of metal clip was(68%±32%);the wound healing score of the control group was(2.50±0.67),and the drop rate of metal clip rate was(67%±35%);The wound healing score of the blank group was(2.25±0.45).There was no statistically significant difference in wound healing scores between the three groups(p>0.05);there was no statistically significant difference in wound healing scores and drop rate of metal clip between the experimental group and the control group(p>0.05).At 28 days after operation,the wound healing scores of the experimental group,the control group and the blank group were all(3.00±0.00),and the difference was not statistically significant(p>0.05);the drop rate of metal clip of the experimental group was(82%±31%),and(100%±0%)for the control group,and the difference was not statistically significant(p>0.05).The HE staining and MASSON staining of the wound healing tissues indicated that the experimental group and the control group had earlier inflammation and collagen fiber proliferation than the blank group,and the degree of inflammation was lighter;there was no significant difference between the experimental group and the control group in inflammation and collagen fiber proliferation.The rate of postoperative infection in the three groups was 25.00%、25.00% and 50.00% respectively;the rate of postoperative bleeding was 8.33%、0% and 12.50% respectively;and the rate of postoperative perforation was 0%、4.17% and 0%,respectively.And all the difference was not statistically significant(p>0.05).Conclusion: The novel suture clip device is superior to purse-string suture using endoloop in terms of closing time and the number of additional metal clips,and it does not increase the risk of postoperative complications such as infection.Therefore,the novel suture clip device is a safe,effective,simple,and economical technique for endoscopic closure,especially for hospitals where only ordinary single-channel endoscopy is available.It has great practical value and is worthy of clinical application. |
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