NCT01460615

Brief Summary

The purpose of this randomized, placebo-controlled trial is to investigate whether postoperative pancreatitis and other immediate complications after pancreaticoduodenectomy or distal pancreatic resection may be reduced with cortisone treatment. Treatment is administered to high risk patients (defined by high amount of acinar cells in the cut edge of pancreas).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 29, 2018

Status Verified

October 1, 2011

Enrollment Period

5.9 years

First QC Date

October 25, 2011

Last Update Submit

November 27, 2018

Conditions

Postoperative ComplicationsPostoperative Pancreatitis

Keywords

Postoperative pancreatitisPostoperative complicationsDelayed gastric emptyingLeakageFistulaAcinar cellRisk patientPancreaticoduodenectomyWhippleCortisone

Outcome Measures

Primary Outcomes (1)

  • Postoperative overall complications of pancreatic resection

    e.g. Postoperative pancreatic fistula, delayed gastric emptying, postpancreatectomy hemorrhage, biliary fistula, wound infection, postoperative pancreatitis.

    within the first 30 days after surgery

Interventions

HydrocortisoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreaticoduodenectomy and distal pancreatectomy patients in Tampere University Hospital

You may not qualify if:

  • Patients with an ongoing cortisone treatment
  • Cefuroxime allergy
  • Chronic pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

Location

Related Publications (1)

  • Laaninen M, Sand J, Nordback I, Vasama K, Laukkarinen J. Perioperative Hydrocortisone Reduces Major Complications After Pancreaticoduodenectomy: A Randomized Controlled Trial. Ann Surg. 2016 Nov;264(5):696-702. doi: 10.1097/SLA.0000000000001883.

    PMID: 27429037DERIVED

MeSH Terms

Conditions

Postoperative ComplicationsGastroparesisFistula

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 27, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 29, 2018

Record last verified: 2011-10

Locations

FI(1)