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Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04281680
Collaborator
(none)
258
Enrollment
22
Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
258 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections
Actual Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Apr 30, 2016
Actual Study Completion Date :
Apr 30, 2016

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. CR-POPF [90 days]

      clinically relevant postpancreatectomy fistula

    Secondary Outcome Measures

    1. Postpancreatectomy complication [90 days]

      Any other surgical or no-surgical complication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    All distal pancreatic resection patients in our time frame

    Exclusion Criteria:

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Helsinki University Central Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tiina Vuorela, LL, attending surgeon, Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT04281680
    Other Study ID Numbers:
    • Helsinki UCH
    First Posted:
    Feb 24, 2020
    Last Update Posted:
    Feb 24, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pancreatic Fistula
    Fistula
    Octreotide
    Pasireotide

    Study Results

    No Results Posted as of Feb 24, 2020