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CompletedNCT03566056Updated Sep 25, 2019

Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

An observational study in Pancreas Cancer, sponsored by Eske Kvanner Aasvang. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Eske Kvanner Aasvang · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

Today the Whipple procedure is the preferred operation for malignancy in the pancreas. In abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (GDT). Despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at Rigshospitalet. Therefore there is still a challenge in the patients who have undergone the Whipple procedure in the acute postoperative phase. This shows in for example at Rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation.

Nevertheless, no studies have in detail described the acute (\<24h) postoperative phase. There is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc..

The purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. Furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. Therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.

02

Conditions studied

  • Pancreas Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients included is chosen from all the patients in the surgery ward when they have undergone the Whipples procedure and furthermore meet the criteria listed above.

Inclusion criteria

  • the patient has undergone the Whipple procedure
  • The patient is over 18 years ol
  • The patient has signed a consent statement from the postoperative therapy ward

Exclusion criteria

Exclusion Criteria:

  • The patient did not receive 125 mg of methylprednisolone prior to the operation
  • The patient did only undergo pancreatectomy
  • The patient wasn't given epidural anesthesia
  • the patient was given anesthesia through a mask
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (actual)
Target follow-up
30 Days
Patient registry
Yes

Interventions

  • OtherComplications to Whipples procedure

    Patients undergoing the Whipple procedure often tend to have a lot of complications. This study aims to investigate what complications these patients experience

05

What researchers measure

Primary outcomes

  1. Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)

    Number of patients with the need for nor-adrenalin infusion to maintain mean arterial blood-pressure \>65 mmHg, the first morning after surgery

    Time frame: 6 am on the day after surgery

06

Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
07

References and documents

Individual participant data

Plan to share: Undecided — This has jet not been discussed within the group

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03566056
Lead sponsor
Eske Kvanner Aasvang
Responsible party
Eske Kvanner Aasvang (Principle investigator, Associate professor, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Jun 21, 2018
Start date
Jan 18, 2018
Primary completion
Jul 18, 2018
Completion
Jul 18, 2018
Last update
Sep 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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