Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Conditions
-----------------
Surgical Complications

Intervention / Treatment
-----------------
* Drug: Pasireotide 0.9 MG/ML


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All distal pancreatic resection patients in our time frame Exclusion Criteria: Included in another clinical trial, received both medications, inadequite patient records

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pasireotide<br>Patients who received pasireotide perioperatively | Drug: Pasireotide 0.9 MG/ML<br>* 900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital<br>* Other names: Control, no-medication group;|
| Octreotide<br>Patients who received perioperative octreotide | |
| Control<br>Patients who received no additional medication in the timely cohort | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR-POPF | clinically relevant postpancreatectomy fistula | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpancreatectomy complication | Any other surgical or no-surgical complication | 90 days |