CHwapi Union Site, 9 Avenue Delmee, 7500, Tournai, Belgium.
Heilig Hart Ziekenhuis Lier, Tournai, Belgium.
Surg Endosc. 2022 Dec;36(12):9462-9468. doi: 10.1007/s00464-022-09616-w. Epub 2022 Nov 1.
The CADISS® system combines the use of a topical formulation of mesna (sodium 2-Mercaptoethane sulfonate) to facilitate selective dissection of pathological and fibrotic tissues with a non-cutting instrument for a safer dissection. A prospective, multi-site, clinical trial was performed to explore the use of the CADISS® system in laparoscopic cholecystectomy for acute cholecystitis.
A total of 15 patients were enrolled at different severity stages of pathology according to Tokyo classification. They were operated on prior to, or after 72 h of, the onset of symptoms. The primary measure was the number of critical dissection steps successfully achieved using the CADISS® system without cutting instruments.
Five patients were operated on before 72 h of symptom onset and ten after. All the dissections were successfully achieved using the CADISS® method. No mortality was recorded. No conversion to open surgery was performed. No bile duct injury was observed. Other endpoints (facilitation of dissection of critical structures, identification of cleavage planes and reduction of risk) had scores of above nine on our Likert scale. Four postoperative serious adverse events including cholangitis, fever, pulmonary embolism and right hepatic artery pseudoaneurysm were reported. However, they seemed to be more related to cholecystitis or local conditions rather than the use of the CADISS® method.
This is the first study to investigate the use of the CADISS® System in cholecystectomy. The CADISS® system seemed to facilitate dissection in acute cholecystitis. Encouraging results are reported independently of the severity grade of cholecystitis and the delay in performing the surgery. Even now, laparoscopic cholecystectomy for acute cholecystitis remains a surgical challenge. Techniques that could facilitate this operation and reduce surgical complications may be helpful. Further studies should be conducted to confirm our preliminary results. Trial registration Clinical trials.gov NCT05041686.
CADISS®系统结合了一种局部制剂的美司钠(巯基乙磺酸二钠)的使用,以促进病理性和纤维组织的选择性解剖,同时使用非切割器械进行更安全的解剖。进行了一项前瞻性、多中心临床试验,以探索 CADISS®系统在急性胆囊炎腹腔镜胆囊切除术中的应用。
根据东京分类,根据病理严重程度的不同,共有 15 名患者入选。他们在症状发作前或发作后 72 小时内进行手术。主要测量指标是使用 CADISS®系统在不使用切割器械的情况下成功完成的关键解剖步骤数量。
5 例在症状发作前 72 小时内手术,10 例在症状发作后手术。所有的解剖均成功地使用 CADISS®方法完成。无死亡病例记录。无中转开腹手术。无胆管损伤发生。我们的李克特量表上其他终点(关键结构的解剖辅助、解剖平面的识别和风险降低)的评分均在 9 分以上。报告了 4 例术后严重不良事件,包括胆管炎、发热、肺栓塞和右肝动脉假性动脉瘤。然而,这些似乎与胆囊炎或局部情况更相关,而不是与 CADISS®方法的使用有关。
这是第一项研究 CADISS®系统在胆囊切除术中应用的研究。CADISS®系统似乎有利于急性胆囊炎的解剖。报告了令人鼓舞的结果,与胆囊炎的严重程度分级和手术延迟无关。即使是现在,急性胆囊炎的腹腔镜胆囊切除术仍然是一项手术挑战。能够促进这一手术并减少手术并发症的技术可能会有所帮助。应进一步开展研究以证实我们的初步结果。试验注册:Clinicaltrials.gov NCT05041686。