Department of General Surgery, Peking University Third Hospital, Beijing 100191, China.
Chin Med J (Engl). 2019 Jun 5;132(11):1354-1358. doi: 10.1097/CM9.0000000000000219.
The enteric reconstruction procedure of pancreatic stump after pancreaticoduodenectomy remains to be the critical factor influencing the mortality and morbidity. No widely accepted surgical procedure for the pancreaticojejunostomy has been erected yet. We have developed a new technique of pancreaticojejunostomy named "shark mouth pancreaticojejunostomy." The aim of this study is to assess the efficacy of "shark mouth pancreaticojejunostomy."
This is a prospective single-arm observational study to evaluate the clinical efficacy of "shark mouth pancreaticojejunostomy." Patients with diseases, in whom a pancreaticoduodenectomy is indicated, would be recruited from Peking University Third Hospital. The hypothesis to be tested is that a "shark mouth pancreaticojejunostomy" will reduce fistula rate from around 20% to less than 10%. A sample size of 120 patients will be needed. The primary endpoint is the incidence rate of postoperative pancreatic fistula (POPF). The secondary endpoints of the study are anastomosis time, postoperative hospital stay, and morbidities besides the POPF such as the hemorrhage. Enrolled patients will undergo pancreaticoduodenectomy and be followed up for 3 months. The relevant data will be monitored and recorded.
The current trial will explore the therapeutic value of the newly raised pancreaticojejunostomy procedure as the "shark mouth pancreaticojejunostomy." Its theoretical base and pragmatic feature will promise high external validity.
Clinical Trials.gov: NCT03366038; https://www.clinicaltrials.gov.
胰十二指肠切除术后胰瘘的肠重建仍是影响死亡率和发病率的关键因素。尚未建立广泛接受的胰肠吻合术。我们开发了一种新的胰肠吻合术，称为“鲨鱼口胰肠吻合术”。本研究旨在评估“鲨鱼口胰肠吻合术”的疗效。
这是一项前瞻性单臂观察性研究，旨在评估“鲨鱼口胰肠吻合术”的临床疗效。将从北京大学第三医院招募因疾病需要行胰十二指肠切除术的患者。待检验的假设是“鲨鱼口胰肠吻合术”将使术后胰瘘（POPF）的发生率从 20%左右降低到 10%以下。需要 120 例患者的样本量。主要终点是术后胰瘘（POPF）的发生率。研究的次要终点是吻合时间、术后住院时间以及 POPF 以外的并发症，如出血。入组患者将接受胰十二指肠切除术，并随访 3 个月。将监测和记录相关数据。
本研究将探讨新提出的胰肠吻合术“鲨鱼口胰肠吻合术”的治疗价值。其理论基础和实用特征将保证较高的外部有效性。
ClinicalTrials.gov：NCT03366038；https://www.clinicaltrials.gov。
