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Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

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Helsinki University Central Hospital

Cuvinte cheie

Abstract

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

Descriere

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.

Datele

Ultima verificare: 01/31/2020
Primul depus: 02/18/2020
Inscriere estimată trimisă: 02/20/2020
Prima postare: 02/23/2020
Ultima actualizare trimisă: 02/20/2020
Ultima actualizare postată: 02/23/2020
Data actuală de începere a studiului: 06/30/2014
Data estimată de finalizare primară: 04/29/2016
Data estimată de finalizare a studiului: 04/29/2016

Stare sau boală

Surgical Complications

Intervenție / tratament

Drug: Pasireotide

Fază

-

Grupuri de brațe

BraţIntervenție / tratament
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

Criterii de eligibilitate

Vârste eligibile pentru studiu 18 Years La 18 Years
Sexe eligibile pentru studiuAll
Metoda de eșantionareNon-Probability Sample
Acceptă voluntari sănătoșida
Criterii

Inclusion Criteria:

All distal pancreatic resection patients in our time frame

Exclusion Criteria:

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

Rezultat

Măsuri de rezultate primare

1. CR-POPF [90 days]

clinically relevant postpancreatectomy fistula

Măsuri de rezultate secundare

1. Postpancreatectomy complication [90 days]

Any other surgical or no-surgical complication

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