Prevention of Clinically Relevant Postoperative Pancreatic Fistula in Pancreaticoduodenectomy With the Novel Technique of Connexion the Pancreatic Duct to Jejunum Stented (CONDUCTJE-ST).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy
研究概览
简要总结
Objective: To assess the efficacy of the "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)" technique to prevent clinically relevant postoperative pancreatic fistula (CR-POPF) after pancreaticoduodenectomy (PD).
Summary Background Data: CR-POPF remains the most determining cause of morbidity and mortality after PD. The incidence of CR-POPF (grades B and C, ISGPS) is around 20% and is a potential source of severe secondary complications that are associated with a mortality of up to 40%.
Methods: A prospective pilot study included 50 consecutive patients who underwent PD with the CONDUCTJE-ST technique, the steps of which are described, performed by the same surgical team from January 2018 to February 2020. No patient received prophylactic or therapeutic somatostatin or its analogues. The primary endpoint was the incidence of CR-POPF. Secondary endpoints were postoperative mortality and morbidity, hospital course and during the first year of follow-up.
In a prospective study we have evaluated a "novel" technique, modification of the preexisting ones, for the reconstruction of the digestive continuity of the corporocaudal remnant in the PD, termed "connexion pancreatic duct to jejunum stented (CONDUCTJE-ST)", applicable to any type of pancreatic remnant, regardless of its texture and the diameter of the main pancreatic duct. The study was planned with the objective of achieving a significant reduction in the incidence of CR-POPF, so that CONDUCTJE-ST could be considered as a surgical procedure of choice in the management of the pancreatic remnant in PD.
详细描述
From January 2018 to February 2020, a PD was performed with the CONDUCTJE-ST technique in 50 consecutive patients by the same surgical team, whose main surgeon has make more than 250 PD, in our Hepatobiliopancreatic Surgery and Liver Transplantation Unit. The study was carried out in accordance with the Declaration of Helsinki and was approved by the Research Ethics Committee of the Community of Aragon (CEICA), Act No. 16/2018. Patient care and study conduct complied with good clinical practices and written informed consent was obtained from each patient.
The selection of patients for surgery was decided collectively by the Multidisciplinary Committee for Tumors of the Liver, Bile ducts and Pancreas of our hospital. No patient received neoadjuvant treatment.
Technical aspects:
Patients received general anesthesia and multimodal pain therapy with an epidural catheter. All patients underwent resection with curative intent, performing PD with antrectomy and standard lymphadenectomy. Immediately after sectioning the pancreas at the level of the isthmus-body, a tissue slice is biopsied from the section margin. In the reestablishment of digestive continuity, we successively perform four reconstructions. The restoration of the flow of pancreatic juice from the corporocaudal remnant towards the intestine was carried out with the technique of "connection of the pancreatic duct to the jejunum with stent (CONDUCTJE-ST)".
Patient characteristics:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age> 18 years
- •informed surgical and anesthetic consents
- •scheduled surgical intervention
- •intention to carry out PD with the CONDUCTJE-ST technique
排除标准
- •emergency PD
- •performing another pancreatic resection technique other than PD
- •associated resection of another viscus
- •metastasis or locally advanced unresectable tumor detected during surgery.
结局指标
主要结局
Incidence of clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy
时间窗: From surgery up to 30 days after pancreaticoduodenectomy
According to the 2016 updated of the ISGPS16, POPF has been defined as any volume of fluid collected in the abdominal drainage on postoperative day 3 or from this day with an amylase level 3 times higher than the normal value serum amylase. CR-POPF has been considered when the criteria for grades B or C were met, while grade A has been replaced by the denomination of biochemical leak. The volume and appearance of the fluid from the abdominal drains was recorded daily. The amylase concentration in the fluid of each of the drains was analyzed on the third and sixth postoperative days, as well as before removing the drain and on any day in which there was a substantial increase in volume or change in the appearance of the fluid.
次要结局
- Incidence of exocrine pancreatic insufficiency(One year after pancreaticoduodenectomy.)
- Severity of postoperative complications(From surgery up to 30 days after pancreaticoduodenectomy)
- Postoperative mortality(From surgery to 30 days after pancreaticoduodenectomy)
- Delayed gastric emptying (DGE)(From surgery up to 30 days after pancreaticoduodenectomy)
- Postoperative hemorrhage(From surgery up to 30 days after pancreaticoduodenectomy)
- Incidence of new-onset diabetes mellitus(One year after pancreaticoduodenectomy.)