Safety and efficacy of nickel-titanium memory alloy compression anastomosis clip in gastroenterostomy

doi:10.3969/j.issn.2095-4344.2016.43.011

Abstract

Abstract:

BACKGROUND: The nickel-titanium memory alloy has been extensively used in blood vessel prosthesis, internal fixation, and orthopedic stents, and its biological characters have obtained better understanding. In the meanwhile, the compression anastomosis technology has been mature.
OBJECTIVE: To evaluate the safety and efficacy of nickel-titanium memory alloy compression anastomosis clip (CAC) in gastrointestinal anastomosis.
METHODS: Totally 64 patients undergoing distal subtotal gastrectomy from June 2013 to February 2016 in Sichuan Provincial People’s Hospital were divided into two groups. Patients in CAC and control groups underwent gastrointestinal anastomosis using the CAC and disposable tantalum nail stapler, respectively.
RESULTS AND CONCLUSION: There were no significant differences in the operation time, stomach jejunum anastomosis time, postoperative exhaust time, eating time and hospitalization time between groups (P > 0.05). No complications such as anastomotic bleeding, anastomotic leakage and delayed gastric emptying occurred in the two groups. There was no anastomotic stenosis in the CAC group, but one case in the control group with the incidence of 3%. The abdominal X-ray examination of CAC group at postoperative 3 days showed that the CAC did not move, and was excreted at postoperative 9-28 days. Six months after operation, the gastrointestinal anastomosis was smooth without congestion and edema under endoscopy. In conclusion, the CAC for gastrointestinal anastomosis is safe and reliable, achieving the same or even better results with a disposable tantalum nail stapler, and will not cause anastomotic complications due to good histocompatibility.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

CLC Number:

R318

Zheng Hang, Yang Chun, Guo Zhi-yi, Wang Kang, Zhang Wei, Hou Neng-yi.

Safety and efficacy of nickel-titanium memory alloy compression anastomosis clip in gastroenterostomy

[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(43): 6458-6464.

Figures/Tables 6

References

[1]李心翔,叶建新,石铮,等.镍钛记忆合金加压吻合夹用于全胃切除术后消化道重建效果分析[J].中国实用外科杂志, 2008,28(7):559-560.
[2]傅木海.镍钛记忆合金加压吻合夹227例胃肠吻合手术的应用体会[D].福州:福建医科大学,2012.
[3]李良庆,傅木海,潘敦.镍钛记忆合金加压吻合夹在胃肠吻合中的应用[J].中华消化外科杂志,2013,12(7):504-507.
[4]曾毅,陈夏,应敏刚.镍钛记忆合金加压吻合夹在腹腔镜结肠癌手术中的应用[J].中华胃肠外科杂志, 2007,10(6): 539.
[5]吴宏梓,史平平,王建民.镍钛记忆合金压力吻合夹在消化道吻合术中疗效及安全性的Meta分析[J].中国循证医学杂志,2014,14(8):942-949.
[6]Ku?nierz K, Lampe P. Long term results of the use of compression anastomosis clips (CAC) in gastrointestinal surgery – the first report. Pol Przegl Chir. 2015;87(6):295-300.
[7]Lee HY, Woo JH, Park SY, et al. Intestinal Anastomosis by Use of a Memory-shaped Compression Anastomosis Clip (Hand CAC 30): Early Clinical Experience. J Korean Soc Coloproctol. 2012;28(2):83-88.
[8]Ku?nierz K, Kajor M, Zaworonkow D, et al. Compression Anastomosis Clips Versus a Hand-Sewn Technique for Intestinal Anastomosis in Pigs. Adv Clin Exp Med. 2015;24(6):1019-1029.
[9]Kusnierz K, Lekston Z, Zhavoronkov D, et al. A nickel-titanium memory-shape device for gastrojejunostomy: comparison of the compression anastomosis clip and a hand-sewn anastomosis. J Surg Res. 2014;187(1):94-100.
[10]Li XX, Zheng CZ, Yin K, et al. Application of laparoscopic compression anastomosis clip for laparoscopic gastrointestinal anastomosis. Zhonghua Wei Chang Wai Ke Za Zhi. 2008;11(3):228-230.
[11]Hua S, Xiong L, Wen Y, et al. Safety and efficacy of gastrointestinal anastomosis with nickel titanium compression anastomosis clip. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2011;36(4):351-354.
[12]Zhang D, Zheng C, Song C. A modified method of using laparoscopic compression anastomosis clip for gastrointestinal anastomosis. Minim Invasive Ther Allied Technol. 2010;19(6):350-354.
[13]Liu PC, Jiang ZW, Zhu XL, et al. Compression anastomosis clip for gastrointestinal anastomosis. World J Gastroenterol. 2008;14(31):4938-4942.
[14]Liem RK, Niloff PH. Clinical experience using the computerized digital stapling system in open gastric bypass surgery for morbid obesity. Obes Surg. 2003; 13(6):837-841.
[15]Tucker ON, Beglaibter N, Rosenthal RJ. Compression anastomosis for Roux-en-Y gastric bypass: observations in a large animal model. Surg Obes Relat Dis. 2008;4(2):115-121.
[16]Li NN, Zhao WT, Wu XT. Can a nickel-titanium memory-shape device serve as a substitute for the stapler in gastrointestinal anastomosis? A systematic review and meta-analysis. J Surg Res. 2016;201(1): 82-93.
[17]Kusnierz K, Morawiec H, Lekston Z, et al. NiTi shape memory compression anastomosis clip in small- and large-bowel anastomoses: first experience. Surg Innov. 2013;20(6):580-585.
[18]Kim HR, Lee WY, Jung KU, et al. Early surgical outcomes of NiTi endoluminal compression anastomotic clip (NiTi CAC 30) use in patients with gastrointestinal malignancy. J Laparoendosc Adv Surg Tech A. 2012;22(5):472-478.
[19]Koo EJ, Choi HJ, Woo JH, et al. Anastomosis by use of compression anastomosis ring (CAR™ 27) in laparoscopic surgery for left-sided colonic tumor. Int J Colorectal Dis. 2012;27(3):391-396.
[20]Chun J, Lee D, Stewart D, et al. Comparison of the compression anastomosis ring (EndoCAR) with a circular stapled anastomosis in a porcine model. Surg Innov. 2011;18(3):235-240.
[21]Stewart D, Hunt S, Pierce R, et al. Validation of the NITI Endoluminal Compression Anastomosis Ring (EndoCAR) device and comparison to the traditional circular stapled colorectal anastomosis in a porcine model. Surg Innov. 2007;14(4):252-260.
[22]Tucker ON, Beglaibter N, Rosenthal RJ. Compression anastomosis for Roux-en-Y gastric bypass: observations in a large animal model. Surg Obes Relat Dis. 2008 r;4(2):115-121.
[23]Song C, Frank T, Cuschieri A. Shape memory alloy clip for compression colonic anastomosis. J Biomech Eng. 2005;127(2):351-354.
[24]Shalimov AA, Kopchak VM, Khomiak IB, et al. Application of the compression biliary-digestive anastomosis in surgical treatment of the biliary ducts obstruction. Klin Khir. 2000;(12):5-8.
[25]Rebuffat C, Rosati R, Fumagalli U, et al. Experimental oesophagogastric anastomosis: preliminary report of a new compression device that also fragments. Br J Surg. 1996;83(11):1616-1619.
[26]Nudelman IL, Fuko VV, Morgenstern S, et al. Gastrointestinal anastomosis with the nickel-titanium double ring. World J Surg. 2000;24(7):874-877.
[27]李良庆,栗大伟,杨洋.镍钛记忆合金加压吻合夹行小肠吻合182例[J].广东医学,2014,35(3):390-392.
[28]蔡绍环,徐志峰,杨永锐,等.镍钛记忆合金加压吻合夹在全胃切除术中的应用[J].医学综述,2013,19(2):379-380.
[29]栗大伟.应用镍钛记忆合金加压吻合夹行小肠吻合的安全性与有效性分析[D].福州:福建医科大学,2012.
[30]华颂文,熊力,文宇,等.应用镍钛记忆合金加压吻合夹行胃肠吻合的安全性与有效性分析[J].中南大学学报(医学版), 2011,36(4):351-354.
[31]Tulchinsky H, Kashtan H, Rabau M, et al. Evaluation of the NiTi Shape Memory BioDynamix ColonRing™ in colorectal anastomosis: first in human multi-center study. Int J Colorectal Dis. 2010;25(12):1453-1458.
[32]Detweiler MB, Kobos JW, Fenton J. Gastrointestinal sutureless anastomosis in pigs using absorbable intraluminal stents, stent placement devices, and fibrin glue - a summary. Langenbecks Arch Surg. 1999; 384(5):445-452.
[33]Robak AN. Use of the shape memory effect of a titanium nickelide spring in a suturing device for the formation of compression esophageal anastomoses. Bull Exp Biol Med. 2008;146(5):620-623.
[34]Jiang ZW, Li N, Li JS, et al. Small bowel anastomosis performed with the nickel-titanium temperature-dependent memory-shape device. Zhonghua Wei Chang Wai Ke Za Zhi. 2006;9(5): 392-394.
[35]Detweiler MB, Verbo A, Kobos JW, et al. Gastrointestinal sutureless anastomosis using fibrin glue: reinforcement of the sliding absorbable intraluminal nontoxic stent and development of a stent placement device. J Invest Surg. 1996;9(2):111-130