Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections
Ключевые слова
абстрактный
Описание
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.
Даты
Последняя проверка: | 01/31/2020 |
Первый отправленный: | 02/18/2020 |
Предполагаемая регистрация отправлена: | 02/20/2020 |
Первое сообщение: | 02/23/2020 |
Последнее обновление отправлено: | 02/20/2020 |
Последнее обновление опубликовано: | 02/23/2020 |
Фактическая дата начала исследования: | 06/30/2014 |
Предполагаемая дата завершения начальной школы: | 04/29/2016 |
Предполагаемая дата завершения исследования: | 04/29/2016 |
Состояние или болезнь
Вмешательство / лечение
Drug: Pasireotide
Фаза
Группы рук
Рука | Вмешательство / лечение |
---|---|
Pasireotide Patients who received pasireotide perioperatively | Drug: Pasireotide 900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital |
Octreotide Patients who received perioperative octreotide | |
Control Patients who received no additional medication in the timely cohort |
Критерии приемлемости
Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
Полы, имеющие право на обучение | All |
Метод отбора проб | Non-Probability Sample |
Принимает здоровых добровольцев | да |
Критерии | Inclusion Criteria: All distal pancreatic resection patients in our time frame Exclusion Criteria: Included in another clinical trial, received both medications, inadequite patient records |
Результат
Основные показатели результатов
1. CR-POPF [90 days]
Меры вторичного результата
1. Postpancreatectomy complication [90 days]