Current partner codePEPTIDESDE
NCT04281680·Not applicable·OBSERVATIONAL

Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Status

Completed

Phase

Not applicable

Enrollment

258

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

Pasireotide 0.9 MG/ML

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

Timeline

From registration to results.

  1. First posted

    Feb 24, 2020

  2. Study start

    Jul 1, 2014

  3. Primary completion

    Apr 30, 2016

  4. Study completion

    Apr 30, 2016

  5. Results posted

    Not reported

  6. Registry updated

    Feb 24, 2020

Outcomes

What the study measures.

Primary outcomes

CR-POPF

Time frame · 90 days

clinically relevant postpancreatectomy fistula

Secondary outcomes

Postpancreatectomy complication

Time frame · 90 days

Any other surgical or no-surgical complication

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pasireotide.

Related PeptideStat pages

Put the record in context.

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