Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

NCT04281680 | Completed

• 1 other identifier: Helsinki UCH
• Study Type: observational
• Target: 258
• Locations: 0 countries
• Sites: N/A

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

Conditions

Surgical Complications

Outcome Measures

Primary Outcomes (1)

• CR-POPF

  clinically relevant postpancreatectomy fistula

  90 days

Secondary Outcomes (1)

• Postpancreatectomy complication

  90 days

Study Arms (3)

Pasireotide

Patients who received pasireotide perioperatively

Drug: Pasireotide 0.9 MG/ML

Octreotide

Patients who received perioperative octreotide

Control

Patients who received no additional medication in the timely cohort

Interventions

Pasireotide 0.9 MG/ML DRUG

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

Also known as: Octreotide, Control, no-medication group

Pasireotide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All distal pancreatic resection patients in our time frame

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Interventions

pasireotide; Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LL, attending surgeon

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: July 1, 2014
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share