Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Surgical Complications Clinical Trial

Official title:

Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281680
• Other study ID #: Helsinki UCH
• Status: Completed
• Start date: July 1, 2014
• Est. completion date: April 30, 2016

Study information

• Verified date: February 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All distal pancreatic resection patients in our time frame

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Surgical Complications

Intervention

Drug:
• Pasireotide 0.9 MG/ML
900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CR-POPF	clinically relevant postpancreatectomy fistula	90 days
Secondary	Postpancreatectomy complication	Any other surgical or no-surgical complication	90 days