A preclinical animal study on a novel domestic endoscopic clip for digestive tract perforation
10.3760/cma.j.cn321463-20240325-00138
- VernacularTitle:国产新型内镜夹治疗消化道穿孔的临床前动物实验研究
- Author:
Dan MA
1
;
Fan YANG
;
Zhendong JIN
;
Yunfeng WANG
Author Information
1. 海军军医大学第一附属医院消化内科，上海 200433
- Keywords:
Animal experimentation;
Gastrointestinal perforation;
Domestically produced novel endoscopic clip;
Over-the-scope-clip system
- From:
Chinese Journal of Digestive Endoscopy
2024;41(9):723-728
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the feasibility, safety and efficacy of a domestic novel endoscopic clip for the treatment of gastrointestinal perforation in an animal model, and discuss its potential clinical adoption.Methods:Eight experimental pigs were randomly assigned to either an experimental group receiving the domestic novel endoscopic clip or a control group receiving an over-the-scope clip system (OTSC) using the random number table. Each animal underwent the creation of 2 cm perforations in the stomach and rectum, which were immediately sealed with clips. The performance, safety, and immediate closure rate of the clips during surgery were evaluated. Endoscopic examinations were conducted on days 3, 7, 14, 21, and 35 post-surgery to assess clip retention and wound healing. At the end of the observation period, animals were euthanized to evaluate wound healing, and histological examinations of the wound sites were conducted.Results:Both groups, consisting of 4 pigs each, successfully created and closed artificial perforations in both the stomach and rectum without intraoperative adverse events in either group such as accidental activation, device failure, or malfunctions in the delivery system. Endoscopic clip performance in the stomach were uniformly rated as 3 in all 4 pigs in the control group, while in the experimental group, 3 pigs were scored as 3 and 1 as 2. For rectal clip performance, 3 pigs were scored as 3 in both groups. One pig were scored as 1 in the experimental group, and the remaining pig in the control group were 2. All pigs survived the observation period without any postoperative complications. One clip (in the control group, rectal site) naturally dislodged during the observation period, while the other clips remained in place. Gross pathological examination revealed that the gastric surgical sites in all 8 pigs and the rectal sites in 7 pigs had healed, with wound healing scores of 3. However, 1 pig (control group) exhibited poor healing of the rectal mucosal incision, with persistent redness and swelling, and a wound healing score of 2. Histopathological examination showed similar levels of inflammation, cell necrosis, and vascular proliferation between the two groups, without ulcer formation observed.Conclusion:The domestically produced novel endoscopic clip exhibits simplicity in operation and demonstrates comparable technical feasibility, safety, and efficacy to OTSC. Its promising clinical application warrants further investigation and promotion through additional clinical research.
