Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

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

Study Overview

• Status: Completed
• Conditions: Surgical Complications
• Intervention / Treatment: Drug: Pasireotide 0.9 MG/ML

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.

• Study Type: Observational
• Enrollment (Actual): 258

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who had pancreatic distal resection done between 2000 and 2016 at our institution.

Description

Inclusion Criteria:

All distal pancreatic resection patients in our time frame

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pasireotide; Patients who received pasireotide perioperatively	Drug: Pasireotide 0.9 MG/ML; 900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital; Other Names: Octreotide; Control, no-medication group
Octreotide; Patients who received perioperative octreotide
Control; 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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): April 30, 2016

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula; Physiological Effects of Drugs; Antineoplastic Agents; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Octreotide; Pasireotide
• Other Study ID Numbers: Helsinki UCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data contains sensitive information, retrospective data analysis. no statements from participants to share information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No