Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

NCT ID: NCT04281680

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 258 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2016-04-30

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.

Conditions

Surgical Complications

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pasireotide

Patients who received pasireotide perioperatively

Pasireotide 0.9 MG/ML

Intervention Type: DRUG

900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital

Octreotide

Patients who received perioperative octreotide

No interventions assigned to this group

Control

Patients who received no additional medication in the timely cohort

No interventions assigned to this group

Interventions

Pasireotide 0.9 MG/ML

900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital

Intervention Type: DRUG

Other Intervention Names

Octreotide; Control, no-medication group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tiina Vuorela

LL, attending surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Helsinki UCH

Identifier Type: -

Identifier Source: org_study_id