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临床试验/NCT04281680
NCT04281680已完成不适用

Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Helsinki University Central Hospital0 个研究点目标入组 258 人开始时间: 2014年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
258
主要终点
CR-POPF

研究概览

简要总结

Between 2000 and 2016 258 distal pancreatectomies were performed at our University Hospital which were included in our analysis. Pasireotide was used in between July 2014 and April 2016. Patients received 900-ug pasireotide administered twice daily perioperatively. We analyzed patients who received octreotide treatment separately. Complications such as fistulas (POPF), delayed gas-tric emptying (DGE), postoperative hemorrhage (PPH), reoperations and mortality were recorded and analyzed 90 days postoperatively

详细描述

In total, between 2000 and 2016 in our University Hospital there were 276 elective distal pancreatectomies performed. In this retrospective cohort study, we included 258 of those distal pancreatectomy patients in the database in to our analysis. Pasireotide was administered preoperatively to all patients undergoing distal pancreatic resection between July 2014 to April 2016, as a part of a new practice in our clinic. One patient received both pasireotide and octreotide, for whom drug delivery was stopped after one day, and who was ex-cluded from analysis. We also excluded nine patients because insufficient data were found. Seven patients were excluded because they were recruited to another clinical study.

In total, 47 patients (18%) received 900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital. We analyzed separately 31 (12%) patients who re-ceived octreotide peri-operatively. All other 180 (70%) distal resection patients operated on beween 2000 and 2016 constituted the control group.

The drug used in this study, pasireotide (Signifor), was supplied by Novartis Europharm Ltd. (Novartis, Basel, Switzerland). The drug manufacturer did not take part in the study nor did it cover any costs.

We collected information about the patient age, gender, the American Society of Anesthesiologists (ASA) Physical Status Classification, tumor histology and grade and type of resection. In addition, we recorded postoperative information, the length of the hospital stay, fever following surgery (>38 °C), complications and surgical and other re-operations.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All distal pancreatic resection patients in our time frame

排除标准

  • Included in another clinical trial, received both medications, inadequite patient records

研究组 & 干预措施

Pasireotide

Patients who received pasireotide perioperatively

干预措施: Pasireotide 0.9 MG/ML (Drug)

结局指标

主要结局

CR-POPF

时间窗: 90 days

clinically relevant postpancreatectomy fistula

次要结局

  • Postpancreatectomy complication(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tiina Vuorela

LL, attending surgeon

Helsinki University Central Hospital

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